Dissertations / Theses on the topic 'Pregnancy and safety'

Class of 2010 Abstract
OBJECTIVES: The purpose of the study was to determine the knowledge of third year pharmacy students about the safety of certain medications during pregnancy and to assess their awareness of an important resource available on medication safety. METHODS: The study used an analytical cross-­‐sectional design. A pre-­‐test was administered to determine baseline knowledge. Dee Quinn provided a presentation on teratogens. The same test was then administered as a post-­‐test to assess the amount of knowledge gained from the presentation. The pre and post-­‐tests were matched for data analysis. A mean and standard deviation were developed for pre and post-­‐test data and the results were compared to each other using a t-­‐test for dependent groups. RESULTS: Students showed a significant increase in knowledge after the presentation (p<0.0001). 78% of students had improved scores after the presentation. 100% of students felt that pharmacists could help make a difference in preventing malformations due to teratogen exposure. There was no significant difference between men and women or students with children and without children. Work experience did not affect knowledge scores. 64% of students felt more comfortable counseling pregnant patients after the presentation. Awareness of the Teratology Information Service improved after the presentation. CONCLUSIONS: After the presentation, students rated themselves as more comfortable speaking with pregnant patients and showed improved knowledge of teratogens. Gender, being a parent and work experience had no relevance on knowledge scores. The investigators recommend that this presentation be given to all students at the College of Pharmacy to improve knowledge in this area.

Worldwide, there is a general lack of knowledge about medication safety during pregnancy. This problem is even greater in developing countries such as Cameroon with no epidemiological data. This PhD thesis provides data on the two arms of pharmacoepidemiological safety studies - use and risk - for anti-infectives in pregnancy. Between February and August 2015, 795 pregnant women attending 23 hospitals in SW Cameroon for antenatal (ANC) or other care were interviewed on first trimester medication use using structured questionnaires. Findings indicated that use of orthodox (73.1%) or traditional (36.9%) medications were common, with a proportion of women (28.7%) combining both. Antimalarials (33.6%) and antibiotics (20.8%) were the 3rd and 4th most commonly consumed group of orthodox medication. Sulfadoxine/pyrimethamine, contraindicated in the first trimester of pregnancy, was the most commonly used antimalarial (13%). Health unit and gestational age at ANC booking were consistent statistically significant predictors of use of different medications. In the second study, 30 congenital anomaly (CA) signals related to antibiotics use identified from the literature were tested in a case-malformed control study using the European Surveillance of Congenital Anomaly (EUROCAT) database covering 8 million births and records for 155,630 livebirths, stillbirths and terminations of pregnancy with CA. Cases were babies/fetus with CAs identified in the 30 signals, and controls were all other malformed babies/fetus. Binary logistic regression results confirmed two signals: congenital glaucoma related to general antibiotics intake (AOR2.11; CI: 1.05, 4.23); and atrioventricular septal defect related to intake of macrolides (AO2.97; CI: 1.47, 5.98). Eight new signals were generated requiring independent confirmation. The last part of this thesis combines the results from both studies to estimate the burden of CAs associated with first trimester use of antibiotics in SW Cameroon and recommends public health measures for safer use of medication in pregnancy in Cameroon.

Unsafe abortions pose serious threats to women's health. Medical abortion provides safer abortion access to many. The lengthy interval between misoprostol and mifepristone creates multiple barriers for women and providers. A paucity of research exists about medical abortion protocols that allow single day procedures. The efficacy and the safety of 3 medical abortion protocols of varying lengths were explored in this study. A secondary data set of over 55,000 patients from the United Kingdom was retrospectively analyzed using binomial logistic regression. Efficacy results showed no significant difference between the conventional and the simultaneous protocols; when compared to those, the 6- to 8- hour protocol showed a 79% higher risk (OR = 0.210, 95% CI = 0.178 - 0.246) of failure. Safety of the simultaneous protocol was 48% lesser (OR = 0.524, 95% CI = 0.447 - 0.613) and the safety of the 6- to 8- hour protocol 61% lesser (OR = 0.386, 95% CI = 0.304- 0.489) compared to the conventional protocol. The absolute risk of complications or severe adverse events of all protocols (0.98%, 1.97%, and 2.67%) was very low. The results suggest the simultaneous protocol is a viable alternative to the conventional protocol up to 10 weeks' gestation. The results could promote the adoption of the simultaneous protocol by health systems, give millions more women access to safe and effective single day medical abortions, reduce the need for skilled clinicians, and reduce cost burdens for both women and for healthcare systems overall. Implementation of these social changes could make abortion safer globally.

Purpose To investigate associations between maternal use of selected medications during early pregnancy and the risk of hypospadias in male infants. Methods We used data from the National Birth Defects Prevention Study, a multi-site, population-based, case-control study. We analyzed data from 1,537 case infants with second or third degree isolated hypospadias and 4,314 male control infants born from 1997-2007. Exposure was based on reported use of any prescription or over-the-counter medication or herbal product, for which there were at least 5 exposed cases, from 1 month before to 4 months after conception, excluding topicals, vitamins, minerals, and products for which the components were unknown. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were estimated using multivariable logistic regression, adjusting for several confounders. Results Of the 195 medication components with at least 5 exposed cases, 89 components met the inclusion criteria and were assessed-28 herbal and 61 non-herbal components. Hypospadias was associated with reported use of cephalexin (aOR 3.06; 95% CI 1.02, 9.18), phenylpropanolamine HCl (aOR 2.68; 95% CI 1.06, 6.80), and ibuprofen (aOR 1.16; 95% CI 1.00, 1.34), in primary analyses. Conclusions We replicated a previously observed association between maternal exposure to phenylpropanolamine HCl and hypospadias. The associations with cephalexin and ibuprofen have not previously been reported. Given the exploratory nature of the analyses, these results should be considered hypothesis-generating. Better understanding of the potential fetal effects will allow clinicians and women of childbearing age to make more informed decisions regarding the use of medications during pregnancy.

Background: In recent years, there has been an increase in the use of automated healthcare databases for drug safety in pregnancy evaluation; their suitability for this purpose needs to be evaluated. Aim: To evaluate the utility of the United Kingdom’s General Practice Research Database (GPRD) to act as an alternative to pregnancy registries, using anticonvulsants as a case study. Methods: Pregnancies in women with epilepsy were identified and first trimester anticonvulsant exposure was determined. Major congenital malformations in the offspring were identified and verified. The risk of major congenital malformations following exposure to a range of anticonvulsants was calculated and compared to those reported by the UK Epilepsy and Pregnancy Register. The ability to identify a known teratogenic association using GPRD data was also assessed. An algorithm was created to identify and classify different types of pregnancy loss in an automated manner. Results: The risks of a pregnancy outcome with a major congenital malformation following first trimester anticonvulsant exposures, were found to be similar in the GPRD to those of the UK Register. The number of exposures to individual products in the GPRD was often small and therefore lacked statistical power. It was, however, possible to identify a known teratogenic association using data from the GPRD. Verification of the algorithm developed to classify pregnancy losses demonstrated that, although not perfect, it would be a beneficial tool when using the GPRD for drug safety in pregnancy research. Conclusion: It is unlikely a single data source or study design will be sufficient for monitoring all aspects of the safety of medicine use during pregnancy. The GPRD has the potential to make a valuable contribution to this field of research and could play an important role in complementing the work of other surveillance systems.

Thesis (MNutr)--Stellenbosch University, 2012.
ENGLISH ABSTRACT: Background: Nausea and vomiting during pregnancy (NVP) is a common medical condition. Due to possible harmful side-effects that conventional medicine may pose to the fetus, many mothers choose not to use it, and are left helpless against NVP. There is a need for alternative treatment to relieve NVP symptoms. Objectives: This systematic review (SR) investigated current evidence regarding ginger for the treatment of NVP. The primary objective was to assess the effectiveness of ginger in treating NVP. The secondary objective was to assess the safety of ginger during pregnancy, by identifying adverse events or side-effects. Search strategy: Electronic search of bibliographic databases (1966-February 2011). Selection criteria: Randomized controlled trials (RCTs) of the efficacy of ginger by any route, as treatment for NVP in pregnant women regardless of their age or stage of pregnancy. Data collection and analysis: The principal investigator and independent reviewer individually identified relevant studies, extracted data and assessed trial quality. Data analysis was performed using the RevMan5 software. Differences at the level of p<0.05 were considered to be statistically significant. Results: Eleven RCTs involving 1176 pregnant women were included. The quality of evidence was low, hence the high risk of bias and imprecision of results. Ginger significantly improved the symptoms of nausea when compared to placebo, when comparing the results of this SR to past SRs, and taking into account a meta-analysis performed on two relatively large included studies (mean difference (MD) 1.20, 95% confidence interval (CI) 0.56-1.84, p=0.0002, I2=0%). However, another meta-analysis on two smaller studies indicated no significant improvement in nausea. Ginger did not significantly improve nausea when compared to vitamin B6 (MD 0.34, 95% CI -1.52-2.20, p=0.7, I2=91%). Similarly, ginger did not significantly reduce the number of vomiting episodes during NVP, when compared to placebo, although there was a trend towards improvement (MD 0.72, 95% CI -0.03-1.46, p=0.06, I2=71%). Subgroup analyses performed seemed to favor the lower daily dosage of <1500mg ginger to possibly be more effective for the relief of nausea. Ginger did not pose a significant risk for spontaneous abortion when compared to placebo (RR 3.14, 95% CI 0.65-15.11, p=0.15; I2=0%), or to vitamin B6 (RR 0.49, 95% CI 0.17-1.42, p=0.19, I2=40%). Similarly, ginger did not pose a significant risk for the side effects of heartburn or drowsiness when compared to placebo or vitamin B6. When compared to dimenhydrinate, ginger posed a smaller risk for drowsiness (RR 0.08, 95% CI 0.03-0.18) and no increased risk for heartburn. Conclusions: This review suggests potential benefits of ginger in reducing nausea symptoms in pregnancy (bearing in mind the limited number of studies, variable outcome reporting and quality of evidence). Ginger did not have a significant impact on vomiting episodes, nor pose a risk for side effects or adverse events during pregnancy. Based on evidence from this SR, ginger could be considered a harmless and possibly effective alternative option for women suffering from the symptoms of NVP. Large RCTs are necessary to confirm the possible benefit of ginger as treatment for NVP.
AFRIKAANSE OPSOMMING: Agtergrond: Naarheid en vomering tydens swangerskap (NVS) is ‘n algemene mediese toestand. As gevolg van moontlike skadelike newe-effekte wat konvensionele medikasie kan veroorsaak vir die fetus, vermy baie moeders dit en word hulpeloos gelaat teen NVS. Dus is daar behoefte aan alternatiewe behandeling vir NVS. Doelwitte: Hierdie sistematiese literatuuroorsig (SO) het huidige literatuur ondersoek wat verband hou met gemmer vir behandeling van NVS. Die primêre doelwit was om effektiwiteit van gemmer as behandeling vir NVS te assesseer. Die sekondêre doelwit was om veiligheid van gemmer tydens swangerskap te assesseer, deur ongunstige gebeure en newe-effekte te identifiseer. Soektogstrategie: Elektroniese soektog van bibliografiese databasisse (1966-Februarie 2011). Seleksiekriteria: Verewekansigde gekontrolleerde proewe (RCTs) van gemmer deur enige roete as behandeling van NVS, in swanger vroue ongeag ouderdom of stadium van swangerskap. Dataversameling en –analise: Die hoof navorser en ‘n onafhanklike hersiener het individueel relevante studies geidentifiseer, data ekstraksie onderneem en studie-kwaliteit geassesseer. Data-analise is uitgevoer deur die RevMan5 sagteware te gebruik. Verskille by die vlak van p<0.05 was beskou as statisties betekenisvol. Hoof resultate: Elf RCTs waarby 1176 swanger vroue betrokke was, is ingesluit. Die studie-kwaliteit was swak, dus die hoë risiko vir sydigheid en onakkuraatheid van resultate. Gemmer het beduidend die simptome van naarheid verbeter in vergelyking met plasebo, wanneer die resultate van hierdie SO met vorige SO’s vergelyk word, en die meta-analise in ag geneem word wat op twee relatiewe groot ingeslote studies uitgevoer is (gemiddelde verskil (MD) 1.20, 95% vertrouens interval (VI) 0.56-1.84, p=0.0002,I2=0%). Kontrasterend, het ‘n ander meta-analise van twee kleiner studies geen beduidende verbetering in naarheid aangedui nie. Gemmer het nie beduidend naarheid verbeter wanneer dit met vitamien B6 vergelyk word nie (MD 0.34, 95% VI -1.52-2.20, p=0.7, I2=91%). Soortgelyk, het gemmer nie die aantal vomerings-episodes verminder, in verglyking met plasebo nie, maar daar was wel ‘n neiging na verbetering (MD 0.72, 95% VI -0.03-1.46, p=0.06, I2=71%). Die subgroup-analise blyk ten gunste te wees van die laer daaglikse dosis van <1500mg gemmer om meer effektief te wees vir die behandeling van naarheid. Gemmer het nie ‘n beduidende risiko ingehou vir spontane aborsie, wanneer dit vergelyk word met plasebo (relatiewe risiko (RR) 3.14, 95% VI 0.65-15.11,p=0.15;I2=0%), of vitamien B6 nie (RR 0.49, 95% VI 0.17-1.42,p=0.19;I2=40%). Soortgelyk, het gemmer nie ‘n beduidende risiko ingehou vir newe-effekte van sooibrand of duiseligheid, wanneer dit vergelyk word met plasebo of vitamien B6 nie. Wanneer dit vergelyk word met dimenhidrinaat, het gemmer ‘n kleiner risiko ingehou vir duiseligheid (RR 0.08, 95% VI 0.03-0.18) en geen verhoogde risiko vir sooibrand nie. Gevolgtrekkings: Hierdie SO dui ‘n potensiële voordeel van gemmer aan in vermindering van naarheid tydens swangerskap (inagnemend van die klein hoeveelheid studies, wisselende uitkomste-rapportering en studie-kwaliteit). Gemmer het nie ‘n beduidnede impak gehad op vomerings-episodes nie, en ook nie ‘n risiko ingehou vir newe-efekte of ongunstige gebeure tydens swangerskap nie. Volgens bewyse uit hierdie SO, kan gemmer beskou word as ‘n skadelose en moontlike effektiewe alternatiewe opsie vir vroue wat lei aan NVP. Grootskaalse RCTs is nodig om die moontlike voordeel van gemmer as behandeling vir NVS te bevestig.

The thesis presents an investigation of pregnant women s safety and comfort needs during car travel. A survey is used to investigate all aspects and problems of car travel. This survey is a comprehensive examination of the entire driving activity with much detail of reported difficulties from pregnant women that forms a novel resource for the automotive engineers. The survey results are used to generate guidelines for the automotive industry. A series of sled tests are presented that investigate seat belt use in pregnancy including the use of lap belt positioners. The peak abdominal pressure results clearly agree with current guidelines that the lap belt should be positioned across the hips and not across the abdomen. This research includes a novel anthropometric dataset for 107 pregnant women including measurements especially selected for the field of automotive design and to describe the changes of pregnancy. This includes investigation of pregnant driver s proximity to the steering wheel. A novel measurement of knee splay is used to define the pregnant women s preference to sit with their knees widely spaced instead of knees together, in both normal sitting and in a car. Comparison is made between the pregnant women's measurements and the available data in the literature for non-pregnant women and males, and this shows that pregnant women can be excluded from designs if the accommodation does not consider their needs. The pregnant women's anthropometric data is presented as a novel website in order to make the data available to the automotive industry. This website is generated for use by automotive engineers and is designed to suit their usability needs and the general trends within the industry, in order to make the site more user-friendly and more likely to be used as a reference for pregnant occupant's needs.

Motor vehicle accidents are statistically the major cause of accidental severe injuries for pregnant women and fetuses fatality. Volunteers, post mortem human surrogates, anthropomorphic crash test devices and computational occupant models are used to improve human safety in motor vehicle accidents. However, due to the ethical issues, pregnant women and their fetuses cannot be used as volunteers or post mortem human surrogates to investigate the effects of crashes on them. The only anthropomorphic test device representing pregnant women is very limited in design and lacks a fetus. There is no computational pregnant occupant model with a fetus other than 'Expecting'. This thesis focuses on understanding the risk of placental abruption for pregnant drivers involved in road accidents, hence assessing the risk to fetus fatality. An extensive review of existing models in general and pregnant women models in particular is reported. The time line of successive development of crash test dummies and their positive effect on automotive passive safety design are examined. 'Expecting', the computational pregnant occupant model with a finite element uterus and a multibody fetus, is used in this research to determine the strain levels in the uteroplacental interface. External factors, such as the effect of restraint systems and crash speeds are considered. Internal factors, such as the effect of placental location in the uterus, and the inclusion and exclusion of a fetus are investigated. The head of the multibody fetus is replaced with a deformable head model to investigate the effects of a deformable fetus head on strain levels. The computational pregnant driver model with a fetus offers a more realistic representation of the response to crash impact hence provides a useful tool to investigate fetus safety in motor vehicle accidents. Seat belt, airbag and steering wheel interact directly with the pregnant abdomen and play an important role on fetus safety in motor vehicle accidents. The results prove that the use of a three-point seat belt with the airbag offer the greatest protection to the fetus for frontal crash impacts. The model without a fetus underestimates the strain levels. The outcome of this research should assist automobile manufacturers to address the potential safety issues at the design level.

Thesis (MMed)-- Stellenbosch University, 2013.
ENGLISH ABSTRACT: Background: Studies about management of prolonged pregnancy dealt with pregnancy with certain gestational age, confirmed with early ultrasound scans. Objective: The primary aim for the study is to review the current management of uncertain gestational age (GA) post term pregnancy in Tygerberg Academic Hospital (TBH). Women at 42 weeks with an uncertain GA and an amniotic fluid index (AFI) of ≥ 10 cm as well as reassuring cardiotocographs (CTG) would be assessed to determine whether follow up over one week or two weeks are required. Method: A retrospective descriptive study included all patients with an uncertain gestation of 42 weeks referred to TBH. Results: A total of 135 pregnant women were studied. Booking fundal height (BFH) was used to determine GA in 99% and last menstrual period (LMP) in 1% of patients. The time interval between first evaluation at 42 weeks and delivery varies between 0 to 46 days (median 10 days); 104 women delivered vaginally (71% spontaneously, 6% after induction of labour (IOL)); 31 women (23%) by caesarean section; 1 elective, 4 due to cephalopelvic proportion (CPD), 5 had failed IOL, 3 poor progress and 18 fetal distress. Out of the total 11 (8%) women with AFI ≥ 10 had caesarean sections for fetal distress within 2 weeks of the visit at 42 weeks. No neonatal morbidity or mortality was noted in this study. Conclusion: Weekly monitoring with AFI and CTG for women at 42 weeks with unsure gestation is safe. A follow-up following 2 weeks cannot be recommended as 8% of women required caesarean sections within less than 2 weeks due to fetal distress.
AFRIKAANSE OPSOMMING: Agtergrond: Studies oor verlengde swangerskap handel oor swangerskappe met seker swangerskapsduurte, bevestig met vroeë ultraklank skandering. Doelwit: Die primêre doelwit van die studie is om die huidige hantering van verlengde swangerskap met onseker swangerskapsduurte by Tygerberg Hospitaal (TBH) te beoordeel. Vroue wat volgens onseker swangerskapsduurte 42 weke swanger is met ‘n amnionvogindeks (AVI) van >10 en gerusstellende kardiotokogramme (KTG) sal nagegaan word om te bepaal of opvolg oor een of twee weke nodig is. Metode: ‘n Retrospektiewe studie wat alle pasiënte insluit wat na Tygerberg Akademiese Hospitaal verwys word wat ‘n onseker swangerskapsduurte van 42 weke het. Resultate: ‘n Totaal van 135 vroue is bestudeer. Die fundale hoogte is gebruik om swangerskapsduurte te bepaal in 99% van gevalle en die laaste menstruasie in 1%. Die tydsinterval tussen die eerste evaluasie op 42 weke en verlossing wissel tussen 0 en 46 dae (mediaan 10 dae); 104 vroue het ‘n vaginale verlossing gehad (71% met spontane aanvang van kraam, 6% na induksie van kraam); 31 (23%) is met keisersnitte verlos; 1 elektief, 4 as gevolg van skedelbekken disproporsie, 5 gefaalde induksies, 3 swak vordering en 18 met fetal nood. Uit die totaal was daar 11 (8%) vroue met ‘n AVI ≥ 10 wat keisersnitte vir fetale nood binne 2 weke van die besoek op 42 weke gehad het. Geen neonatale morbititeit of mortaliteit het in die studie voorgekom nie. Gevolgtrekking: Weeklikse monitering met AVI en KTG vir vroue wat 42 weke swanger is met onseker swangerskapsduurte, is veilig. Opvolg na 2 weke kan nie aanbeveel word nie want 8% het keisersnitte vir fetale nood gehad na minder as 2 weke.

Research involving human subjects must be performed with standards that promote protection of their rights. Several codes were developed and all are unanimous in the following ethic principles: respect for persons, beneficence and justice. The fulfilment of these principles will assure that the dignity, rights, safety and well-being of the participants in a biomedical research are guaranteed.

The need of a special protection to those with diminished autonomy is a common requirement to all codes. Pregnant women are defined as a vulnerable population because of the potential risk of harm of the foetus. Apart from the foetal risk, pregnant women in developing countries have additional potential for vulnerability, as in most of the cases they are economically or/and educationally disadvantaged individuals. Their generally low level of education may put them in a difficult situation to fully understand consent forms and the risk-benefit assessment provided by the researchers.

In recent years, the evidence-based medicine has been an important international goal. Mechanisms to support the use of research-based evidence in developing health policy are being promoted. The research must be sensitive to the potential for vulnerability when designing evidence-based trials and they have to assure that the vulnerable population is being protected.

With the intention to protect the vulnerable population, some groups such as pregnant women have being traditionally excluded from clinical trials. As a result of this exclusion, pregnant women are being exposed to medicines in situations where no evidence-based information is available on efficacy and safety. They are deprived of the benefits of treatment in order to be protected themselves and their offspring from an unknown risk. Although is very clear that protection of a vulnerable population, particularly the pregnant women, is mandatory in the design of any trial, the challenges of the implementation of this principle should be taken into account in order to not increase the gap between the introduction of a pharmaceutical product in the market and the availability of safety information for its use in pregnancy.

In developing countries maternal mortality is an important public health problem. Most maternal deaths occur in the poorest countries particularly in Sub-Saharan Africa. In Mozambique the rate could be between 408-1000 per 100 000 live births according to the source of information. Several studies have addressed different causes of maternal mortality in Africa, eclampsia and malaria being part of the five most reported.

There is strong evidence of the effectiveness of magnesium sulphate (MGSO4) in women with pre-eclampsia and eclampsia but the drug is not available in some countries. The example of MgSO4 has being used to describe failure in translating results of research into policy and/or practice.

For malaria treatment few drugs were considered effective and safe for use during pregnancy including chloroquine, sulphadoxine-pyrimethamine and quinine. The information on safety comes from a long experience of use. The emergency of resistance of P. falciparum to these drugs is limiting its use in most of endemic areas. The artemisinin derivatives are being strongly recommended to be used in combination with other antimalarial drugs. Preclinical studies have consistently shown that artemisinin and its derivatives are embryolethal and teratogenic in animals. Current available information is not adequate to extrapolate the results in animals to humans.

Limited data on the safety profile of antimalarial drugs during pregnancy is a challenge. Nowadays these drugs are used in pregnant women based on retrospective cumulative risk-benefit assessment. Mechanisms of prospectively monitoring the drugs use are required to protect pregnant women from the potential risk.

The aim of this thesis is to describe the (un)availability of drugs and their reasons, as well as, the (un)availability of safety information on drugs needed to be used during pregnancy in Southern Africa, and to propose mechanisms to effectively monitor drug safety in pregnancy in developing countries.

In order to achieve this objective four studies were performed. In the first study a qualitative case-study based on interviews and bibliographic review was performed in Mozambique and Zimbabwe. Factors affecting the (un)availability of MgSO4 were assessed. This study showed that research evidence regarding the effectiveness of MgSO4 for the treatment of eclampsia and pre-eclampsia, was widely known in the study countries. However, the registration, approval, acquisition and distribution of MgSO4, and hence its availability to clinicians, was affected by market and systems failures. With this study we concluded that the low cost of magnesium sulphate, as well as the mechanisms through which it is procured, means that market forces alone cannot be relied upon to ensure its availability. Governments and international organizations must be prepared to intervene to ensure the wide availability of low cost, effective drugs critical to improving public health in Africa.

The second and the third studies shown that antimalarial drugs are being used in pregnant women even without information on its safety profile in this particular group. Robust safety monitoring systems are clearly needed in developing countries to accompany the deployment of new drugs, especially those with a potential teratogenic risk.

The fourth study showed that spontaneous reporting system may be a tool for drug safety monitoring. This system could be used to increase health care providers' and patients' awareness of possible ADRs, and to develop a culture to report these reactions. Spontaneous reporting and pregnancy registries were presented as examples of mechanisms that could and should be in place.

Recommendations on how these systems could be effectively implemented in resource constrained countries were also presented.

All these studies suggest that the definition of vulnerability of pregnant women in developing countries should not be restricted to the potential risk of harm of the foetus (harm-based definition) or to the difficulty of fully understanding consent forms (consent-based definitions). Women are also vulnerable because of the high risk of dying from any cause related to or aggravated by the pregnancy. The implementation of these ethic principles need to take into account the urgent need to implement effective and safe drugs targeted to reduce the burden of maternal morbidity and mortality.
La investigación relativa a los seres humanos debe realizarse dentro de unos estándares que promuevan la protección de sus derechos. Varios códigos han sido desarrollados y todos ellos coinciden unánimemente en los siguientes principios éticos: el respeto por las personas, la beneficencia y la justicia. La realización de estos principios debe asegurar la dignidad, los derechos, la seguridad y el bienestar de los participantes en una investigación biomédica sean preservados.

La necesidad de una protección especial hacia aquellos seres cuya autonomía sea limitada es un requerimiento común para todos los códigos. Las mujeres embarazadas están definidas como un grupo de población vulnerable dado el riesgo potencial de causar daño al feto. Además del riesgo para el feto, las mujeres embarazadas en los países en desarrollo son potencialmente más vulnerables, y suelen contar con desventajas a nivel económico y/o educativo. Su nivel de educación, por lo general bajo, les pone en una situación difícil, dificultando la comprensión de los formularios de consentimiento y la evaluación del riesgo-beneficio que prestan los investigadores.

En los últimos años, la medicina basada en la evidencia ha sido una meta muy importante a nivel internacional. Se están promoviendo mecanismos para respaldar el uso de la evidencia científica para la definición de política de desarrollo de la salud. La investigación debe ser sensible a la vulnerabilidad potencial cuando se diseñan ensayos basados en la evidencia. Además, se debe asegurar que la población vulnerable esté siendo protegida.

Con la intención de proteger a esa población vulnerable, algunos grupos como los de mujeres embarazadas han sido tradicionalmente excluidos de los ensayos clínicos. Como resultado de esta exención, algunas mujeres embarazadas están siendo expuestas a medicamentos de los que no hay información basada en la evidencia en cuanto a su eficacia y seguridad. Este hecho las priva de los beneficios del tratamiento que debería protegerlas, a ellas y sus hijos, de un riesgo desconocido. Aunque está muy claro que proteger a una población vulnerable, particularmente a las mujeres embarazadas, es obligatorio en el diseño de un ensayo clínico, los retos de la implementación de este principio no deberían aumentar el vacío entre la introducción de un producto farmacéutico en el mercado y la disponibilidad de información sobre su seguridad para uso en el embarazo.

En los países en vías de desarrollo la mortalidad materna es un problema importante de salud pública. La mayoría de muertes maternas ocurren en los países más pobres, particularmente en África Subsahariana. En Mozambique el índice puede ser entre 408-1000 por 100000 nacidos vivos, dependiendo de la fuente de información. Diferentes estudios han señalado diversas causas de mortalidad materna en África, encontrándose la eclampsia y la malaria entre las cinco primeras.

Existe una gran evidencia de la eficacia del sulfato de magnesio (MGSO4) en mujeres con pre-eclampsia y eclampsia, sin embargo el fármaco no está disponible en algunos países. El ejemplo del sulfato de magnesio se ha utilizado para describir el fracaso en el traslado de los resultados de la investigación a la práctica y/o política.

Para el tratamiento de la malaria, se consideró seguro el uso durante el embarazo de algunos fármacos incluyendo cloroquina, sulfadoxinapirimetamina y quinina. La información sobre seguridad responde a una gran experiencia de uso. El aumento de resistencia de P. falciparum a estos fármacos está limitando su uso en la mayoría de las zonas endémicas. Actualmente se está recomendando el uso de los derivados de la artemisinina en combinación con otros fármacos antimaláricos. Los estudios preclínicos han mostrado sistemáticamente que la artemisina y sus derivados son embrioletales y teratogénicos en animales. La información disponible hasta la fecha no es adecuada para extrapolar los resultados de los animales a los humanos.

Los datos limitados en el perfil de seguridad de los fármacos antimaláricos durante el embarazo constituyen un desafío. Hoy en día, estos fármacos se usan en mujeres embarazadas basándose en una valoración retrospectiva acumulativa de riesgo-beneficio. Se necesitarían mecanismos de monitorización prospectiva del uso de los fármacos para proteger a las mujeres de su riesgo potencial.

El objetivo de esta tesis es el de describir la disponibilidad o no disponibilidad de los fármacos y sus razones; describir la disponibilidad o no disponibilidad de información sobre la seguridad de estos fármacos que son de uso necesario en el sureste de África. Se pretende también proponer mecanismos efectivos para monitorizar la seguridad de los fármacos en el embarazo en los países en desarrollo.

Para alcanzar estos objetivos se llevaron a cabo cuatro estudios. El primero consistía en un estudio cualitativo de casos basados en entrevistas y en una revisión bibliográfica en Mozambique y Zimbawe. Se evaluaron los factores que afectaban a la disponibilidad o no disponibilidad del sulfato de magnesio. El estudio mostró que la evidencia científica respecto a la eficacia del sulfato de magnesio para el tratamiento de la eclampsia y la pre-eclampsia fue ampliamente conocida en los países del estudio. Sin embargo, el registro, aprobación, adquisición y distribución del sulfato de magnesio y como consecuencia, su disponibilidad para los médicos se vio afectada por fallos de mercado y de sistema. Este estudio concluye que el bajo coste del sulfato de magnesio, así como el mecanismo a través del cual se obtiene, significa que las fuerzas del mercado por si solas no pueden asegurar su disponibilidad. Los gobiernos y las organizaciones internacionales deben estar preparados para intervenir y para asegurar una amplia disponibilidad de fármacos efectivos de bajo coste, críticos para mejorar la salud pública en África.

El segundo y tercer estudio mostraron que los fármacos antimaláricos se están usando en mujeres embarazadas sin contar con información sobre su perfil de seguridad en este grupo particular. Se necesita claramente una monitorización fuerte y segura en los países en vías de desarrollo para acompañar el despliegue de los nuevos fármacos, especialmente aquellos que conllevan un potencial riesgo teratogénico.

El cuarto estudio mostró que el sistema de notificación espontánea puede ser una herramienta para la monitorización de la seguridad de los fármacos. Este sistema se podrá usar para incrementar la consciencia en proveedores de salud y en enfermos sobre las posibles reacciones adversas de fármacos. Ello permitirá desarrollar una cultura de notificación de estas reacciones. La notificación espontánea y los registros de embarazo se presentaron como ejemplos de mecanismos que podrían y deberían ser implementados. Las recomendaciones de cómo estos sistemas podrían ser implementados de forma efectiva en países con recursos limitados también fueron presentadas.

Todos estos estudios sugieren que la definición de vulnerabilidad de las mujeres embarazas en los países en desarrollo no se puede restringir a causa del riesgo potencial de daño al feto, o debido a la dificultad de entender por completo los formularios de consentimiento. También son vulnerables por el riesgo elevado de morir por alguna causa relacionada o agravada por el embarazo. La implementación de estos principios éticos necesita tener en cuenta la necesidad de implementar fármacos diana efectivos y seguros para reducir la mortalidad y morbilidad materna.

This program evaluated the effectiveness of the program interventions implemented during the 2002-2003 school year in the Riverside County Office of Education's Cal-SAFE pregnant and parenting minor program. Two researchers divided the twelve school sites, gathered data and formulated information to assess the effectiveness of the program on continuance or completion of high school after teen pregnancy.

Fescue toxicosis is a condition that afflicts livestock grazing endophyte-infected tall fescue and is particularly detrimental to pregnant mares. A two year evaluation study of a novel endophtye-infected cultivar, AGRFA-144 (A-144), did not induce fescue toxicosis in late-term pregnant mares. All mares delivered viable foals except in E+ group which had two viable foals, one stillborn-dystocia and one compromised foal which was euthanized at 72 h pp. Serum P4 concentrations were similar among A-144, NE+, and E- mares (p>0.05). Foal BW and foal/placental weight ratios were similar for A-144, NE+, and E- (p>0.05). Foal serum P4 was similar on 1 d and 2 d in all groups, but was lower (p = 0.049) in the A-144 group than the E- foals on day 0. Neutrophil/lymphocyte ratios were similar (~5:1) in all foals on d 0 and 2. IgG values were similar (p>0.05) among A-144, NE+, and E-.

A safety study was then carried out in VIVO III normal pregnant mice. The most commonly used single herb, Largehead Atractylodes Rhizome, at relevant clinical doses was administered orally to the pregnant animals at different or throughout gestational periods, beneficial and adverse effects on both mothers and offspring were studied. At higher clinical dosage, significant decreased maternal weight, fetal/neonatal growth and weight; and significant increased incidences of fetal resorption, congenital caudal regression and hip dysplasia were recorded . Bone CT examination and skeleton staining confirmed congenital skeleton abnormality, including shoulder joint dislocation, congenital absence of ulna and distal digits, oligodactyly, long bone shortening, congenital hip dislocation and caudal regression In vitro whole embryo culture confirmed that Largehead Atractylodes Rhizome induced abnormal limb development during early development. Molecular study suggested the effects of Largehead Atractylodes Rhizome on Tbx suppression for early limb development.
For more than 3,000 years of history, Traditional Chinese Medicine has been used in pregnant women. Nowadays, it is principally applied in Mainland China but has become more and more widely used worldwide to promote both mothers ' and fetuses ' health and treat common pregnancy disorders.
Over 3,000 publications were identified and selected to assess Chinese medicines for pregnancy, including their indications, contraindications, formulae , individual medicines, regimes, effectiveness , efficacy, safety, adverse effects and toxicity. Amongst all clinical applications, threatened miscarriage was the most common clinical indication. Shou Tai Pill, containing 4 major herbal medicines Chinese Dodder Seed, Chinese Taxillus Twig, Donkey-hide Glue, and Himalayan Teasel Root, was the most commonly used formula in preventing miscarriage and promoting pregnancy. The top 10 most frequently prescribed single herbal medicines in wide variety of formulas were identified. The average clinical dose for each medicine ranged from 6g to 28g daily, however the dosage of Chinese medicines was not significantly correlated with its overall efficacy. Randomized controlled trials evaluating the effectiveness of the medicines were selected for meta-analysis. The results showed Chinese medicines in combination with other pharmaceuticals were more effective to improve the clinical outcomes of threatened miscarriages than other pharmaceuticals. No specific safety problem was reported, but potential adverse and toxic effects on reproductive system by certain medicines were identified from other publications.
To date, no data are available to provide an overview of Chinese medicines in pregnancy. In the first part of this study, the clinical applications, and therapeutic effects and safety of Chinese medicines for pregnancy were reviewed and studied. In the second part of this study, the safety of most commonly used Chinese medicine during pregnancy was studied in pregnancy animal models, in vivo and in vitro.
Li, Lu.
Adviser: Wang Chi Chiu.
Source: Dissertation Abstracts International, Volume: 73-04, Section: B, page: .
Thesis (Ph.D.)--Chinese University of Hong Kong, 2011.
Includes bibliographical references (leaves 299-330).
Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web.
Electronic reproduction. [Ann Arbor, MI] : ProQuest Information and Learning, [201-] System requirements: Adobe Acrobat Reader. Available via World Wide Web.
Abstract also in Chinese.

L’asthme est l’une des maladies chroniques les plus fréquentes durant la grossesse, affectant environ 4% à 12% des femmes enceintes et ayant une prévalence qui a augmenté au cours des dernières décennies. Plusieurs études ont identifié l'asthme comme un facteur de risque pour plusieurs enjeux de santé défavorables chez le fœtus et la mère. Les lignes directrices de traitement recommandent l’utilisation de médicaments antiasthmatiques pendant la grossesse afin de contrôler l’asthme et d’éviter les problèmes de santé maternels et fœtaux. L’évaluation de la littérature sur l'utilisation maternelle de médicaments antiasthmatiques et le risque de malformations congénitales majeures a relevé plusieurs études sur l’innocuité des bêta2-agonistes inhalés à courte durée d’action (BACA) et des corticostéroïdes inhalés (CSI) pendant la grossesse, mais peu de données sur les bêta2-agonistes à longue durée d’action (BALA) ainsi que sur les thérapies combinées (BALA-CSI). Un programme de recherche en trois volets a été développé pour combler ces lacunes. Dans le premier volet, nous avons entrepris une revue systématique de la littérature sur l'impact de l'utilisation de BACA et de BALA pendant la grossesse sur le risque de différents problèmes périnataux. Vingt et une études originales ont été identifiées. Quatre études ont rapporté une augmentation significative du risque de malformations congénitales avec BACA, une étude a rapporté une augmentation significative du risque de malformations congénitales avec BALA et quatre études ont rapporté un risque significatif accru de malformations congénitales avec bêta2-agonistes (BACA et/ou BALA). Toutefois, aucun risque majeur n’a été trouvé pour les autres complications périnatales. Fait important, la plupart des études récupérées ont subi plusieurs limitations méthodologiques, y compris l'utilisation des femmes non-asthmatiques comme groupe de référence et la faible puissance statistique. De plus, les résultats qui en découlent doivent être interprétés avec prudence. Dans le deuxième volet, nous avons utilisé la base de données Québec Asthma and Pregnancy Database qui comprend toutes les grossesses de femmes asthmatiques et un échantillon aléatoire de femmes non-asthmatiques ayant accouchées entre 1990 et 2010 pour effectuer deux études. La première était une étude comparant la prévalence des malformations congénitales majeures entre les femmes enceintes asthmatiques traitées avec une combinaison de BALA-CSI et celles traitées avec une dose plus élevée de CSI en monothérapie. Dans une sous-cohorte, il y’avait 643 femmes qui utilisaient un BALA plus CSI à dose faible et 305 qui ont utilisé une dose moyenne de CSI ; l'autre sous-cohorte comprenait 198 utilisatrices de BALA plus CSI à dose moyenne et 156 utilisatrices de CSI à dose élevée. La prévalence de malformations majeures a été 6,9% et 7,2%, respectivement. Le risque de malformations congénitales majeures était similaire entre ces deux groupes de femmes avec un odds ratio ajusté (OR) de 1,1 (IC 95%: 0,6-1,9) pour les femmes souffrant d’asthme modéré et un OR ajusté de 1,2 (IC 95%: 0,5-2,7) pour les femmes souffrant d’asthme sévère. La seconde était une étude méthodologique visant à étudier l’impact de six différentes définitions opérationnelles de malformations congénitales qui varient selon la source des données et la méthode de classification sur l’estimation de la prévalence des malformations et de l'association entre l'asthme maternel et les malformations majeures. Sur 467,946 grossesses, 12,3% étaient de femmes enceintes souffrant d’asthme actif. Nous avons démontré que la source des données et la méthode de classification ont eu un impact considérable sur la prévalence des malformations congénitales majeures (augmentation entre 10,0% et 50,4%), alors qu’elles ont eu peu d’influence sur l’association entre l’asthme maternel et les malformations congénitales. Dans le troisième volet du programme de recherche, nous avons développé une procédure systématique pour la classification des médicaments utilisés au cours du premier trimestre de grossesse en agents tératogènes et potentiellement tératogènes dans un contexte de recherche. Nous avons développé une procédure systématique qui s’actualise facilement, avec des composantes objectives dans la plupart de ses processus. Nous avons établi une liste comprenant 91 médicaments tératogènes, et une autre liste comprenant 81 médicaments potentiellement tératogènes. Les résultats présentés dans cette thèse ont fourni des données importantes sur l’innocuité des traitements de l'asthme pendant la grossesse, aidant les cliniciens et les femmes enceintes à choisir un traitement pharmacologique sécuritaire pour maintenir l’asthme sous contrôle. De plus, les données présentées dans cette thèse sur la minimisation du biais d'indication, les définitions opérationnelles de malformations congénitales et l’identification des médicaments tératogènes pourront aisément être utilisées par les chercheurs en pharmacoépidémiologie, en tératologie et en épidémiologie périnatale.
Asthma is one of the most prevalent chronic diseases during pregnancy, affecting about 4% to 12% of pregnant women and shows an increasing prevalence over time. In the past decades, several studies have identified asthma as a risk factor for several poor fetal and maternal outcomes. A consensus exists on favoring the use of asthma medications during pregnancy to maintain asthma under control to prevent adverse maternal and fetal outcomes. An assessment of the published literature on maternal asthma medications and the risk of major congenital malformations revealed more data on the safety of short-acting beta2-agonists (SABA) and inhaled corticosteroids (ICS) during pregnancy compared to long-acting beta2-agonists (LABA), as well as a paucity of data on the fetal safety of combination therapies (e.g. LABA-ICS). A three-part research program was developed to fill this knowledge gap and answer other intriguing questions we faced, adding necessary evidence in this field. In the first part, we summarized the published evidence on the impact of maternal use of SABA and LABA during pregnancy and different perinatal outcomes in a comprehensive systematic review. Twenty-one original studies were identified. Four studies reported a significant increased risk of congenital malformations with SABA, one study reported a significant increased risk of congenital malformations with LABA and four studies reported a significant increased risk of congenital malformations with beta2-agonists (SABA and/or LABA). However, no major increased risk was found for the other perinatal outcomes. Importantly, most of the retrieved studies suffered several methodologic limitations, including using non-asthmatic women as the reference group and low statistical power. Moreover, the non-significant results reported should be interpreted with caution. In the second part, we used the Quebec Asthma and Pregnancy Database – which includes all pregnancies in asthmatic women and a random sample in nonasthmatic women between 1990 and 2010 – to conduct two studies. The first was a comparative safety study examining the prevalence of major congenital malformations in pregnant asthmatic women treated with a combination of LABA-ICS compared to those treated with a higher dose of ICS monotherapy. In one subcohort there were 643 women who used a LABA plus low-dose ICS and 305 women who used a medium-dose ICS; the other subcohort included 198 users of a LABA plus a medium dose ICS and 156 users of a high-dose ICS. The prevalence of major malformations was 6.9% and 7.2%, respectively. The risk of major malformations did not differ when a combination therapy was used among both moderate and severe asthmatic women (aOR: 1.1; 95% CI: 0.6–1.9 and aOR: 1.2; 95% CI: 0.5–2.7 respectively). The second was a methodological study aiming to compare the prevalence of major malformations using six different case ascertainment definitions that vary by the source of data and the classification method, as well as to evaluate the impact of these definitions on the association between maternal asthma and major malformations. From the 467,946 pregnancies, 12.3% were with active asthma. We demonstrated that the source of data and the classification method had a considerable impact on the prevalence of major malformations (increases between 10.0% and 50.4%), but only a small influence on the measure of association. In the third part of the research program, we aimed at constructing a systematic procedure for the classification of proven and potential teratogenic medications during the first trimester of pregnancy to be used for research. We structured a procedure that is both systematic and updatable, with objective components in most of its processes. We identified a substantial list of teratogenic medications, including 91 medications, and an extensive list of potentially teratogenic medications, including 81 medications. The results presented in the current thesis provided essential evidence on the safety of asthma treatments during pregnancy, helping clinicians and mothers to choose the optimal therapeutic regimen to keep asthma under control. The added knowledge on indication bias minimization, congenital malformations ascertainment and teratogenic medications are directly transferable to researchers in pharmacoepidemiology, teratology and other related research fields.

碩士
嘉南藥理大學
觀光事業管理系
106
The birth population in Taiwan has been declining year by year. Many literatures support moderate exercise to help the development of the fetus. Especially in the third trimester, there are general problems of lower extremity edema and low back pain. The hydrostatic pressure is used to reduce the burden during pregnancy, but it is based on traditional practices in Taiwanese pregnant women. The attitude towards the use of recreational activities in the waters is still conservative. In this study, pregnant women were surveyed using the safety and health awareness of recreational activities in the waters during pregnancy. The facets included: efficacy identification, consumption cognition, risk identification and safety and health identification in the use of water recreation activities during pregnancy. The survey targets pregnant women in Chiayi and Tainan. There are 137 valid questionnaires. The results showed that the willingness to use recreational activities in the waters during pregnancy was only 38, compared with 68 in the non-pregnancy period, a clear 56% difference. In any case, respondents had a high level of recognition for the use of recreational activities in the waters during pregnancy, with 85.4% of those who agreed and strongly agreed to improve sleep quality. A survey of consumption perceptions in the field of recreational activities in the waters shows that pregnant women have the highest demand for “emergency SOS” conditions, and 97.1% agree and agree. The risk identification survey using leisure activities during pregnancy showed that “water quality sanitation management conditions” was the first choice, with 94.9% consent and non-consensus. According to the safety and health approval survey, "the difference between water temperature and room temperature is too large" is the worrying item that pregnant women think is the safest and the healthest, and the agreement and the unrecognized person are up to 84.7%. Cross-analysis results show that the socio-economic background is different, and the efficacy identification, consumption cognition, risk identification and safety and health identification of the use of water leisure activities during pregnancy, and most cross-analysis items all show significant differences in chi-square test, but cross-analysis The items are still quite different from each other. On behalf of the pregnant women's society and the background of pregnancy, their views are still different. It means that the leisure activities of the waters should provide a multi-use thinking and relatively safe and healthy environment for pregnant women. In addition, the fear of increasing the risk of miscarriage is the reason for indirectly affecting the frequency of recreational activities in the waters during pregnancy. The research results suggest that in the era of user payment, the industry should comprehensively examine the needs of the consumer groups, and should indirectly reflect the service quality management of hardware equipment and water quality sanitation and safety to obtain consumer recognition.

Untreated depression in pregnancy may result in adverse health outcomes to both the mother and her unborn child. Pharmacotherapy with antidepressants is the most common treatment option for depression; however, the decision to treat with medication becomes complicated by pregnancy. Risk benefit assessments are critical tools to guide the treatment decision. Factors that should be included in these analyses include the pharmacokinetics and pharmacodynamics of antidepressants in pregnancy and their maternal and fetal safety. The economic cost of untreated maternal depression is also important to keep in mind. When the pharmacokinetics of the antidepressants venlafaxine and bupropion were studied in pregnancy it was found that the apparent oral clearance rate of bupropion was increased in late pregnancy when compared to early pregnancy (p = 0.03). There was a trend for lower area under the curve for these medications when the third trimester was compared to the first trimester. When the metabolism of antidepressants was investigated using hair analysis it was found that there was increased metabolism in pregnancy when compared to the postpartum period for citalopram (p = 0.02) but not venlafaxine (p = 0.77). Follow up of depressive symptoms throughout pregnancy identified that depression scores were highest in the first trimester of pregnancy, which may be due to concurrent nausea and vomiting of pregnancy. A meta-analysis of paroxetine use in early pregnancy demonstrated that there was no increased risk for cardiac malformations; case-control studies had an odds ratio of 1.18 (CI95: 0.88 – 1.59) while a weighted average difference of 0.3% was found in case-control studies (CI95: -0.1 – 0.7%, p = 0.19) The direct medical costs incurred by the Ontario government due to discontinuation of antidepressant medications in pregnancy was estimated to exceed $20,000,000 CAD. The management of depression in pregnancy with pharmacotherapy is an important and complex issue. My study documents the advantages of conducting risk benefit assessments for vulnerable populations such as pregnant women with depression.

The following thesis seeks to inquire whether the recent phenomenon of women seeking out and indeed actively engaging with a medicalised birth stems from a shift in not only perceptions of risk, but also how a shift in responsibility, choice and control has impacted on the birthing women of Australian society. The thesis examines sociology of risk employing the work of both Beck and Giddens, although an emphasis will be placed on the work of Ulrich Beck. The three major themes that underpin the work of Beck, namely his risk society thesis, reflexive modernization and individualization are employed to explore some of the issues that concern the relationship between risk and society, the ramifications of this form of society on its inhabitants and specifically in relation to its impact on those experiencing pregnancy and childbirth. The Risk Society as an explanatory framework was empirically tested by conducting 45 interviews with women who had recently given birth from three separate birthing environments: private birth mothers, birth centre and home birth mothers. The argument is put forward that whilst previous research into the area of childbirth is clearly important in shedding a critical light upon childbirth practices, it does nevertheless neglect some important current social changes. In this respect, the application of Beck and Giddens work to the area of sociology of reproduction captures more adequately the ideological shift which this thesis examines. It is argued, through the scrutinizing gaze of the public, that the pregnant woman is the least able to escape the consequences of risk society where changed notions of health and responsibility have created a cultural acceptance of medical intervention of childbirth.
Doctor of Philosophy (PhD)

Trabalho de projecto de mestrado, Tradução, Universidade de Lisboa, Faculdade de Letras, 2009
The present paper deals mainly with semantic points from the translation of Medication Safety in Pregnancy and Breastfeeding The Evidence Based A-to-Z Clinician's Pocket Guide, by Gideon Koren, which choice was motivated by the lack of translated material in medical literature in European Portuguese language. It is necessary to mention that a great part of the literature was translated into Brazilian Portuguese, making doctors and students of medical sciences to turn to these translations or, as a last resort, to the original texts written on a foreign language. In any of the cases, since Portuguese health professionals frequently have little or any skills in foreign languages, and due to stressful differences between European Portuguese and the variety of Brazilian Portuguese, neither of the solutions is perfect. In this way, this translation project volunteers, somehow, to minimize the lack of translated scientific texts in European Portuguese. The practical point of this paper concerns to the translation of the textes into two different registres, bearing in mind that the book is not only for public health professionals, but also for general public. That way, on the one hand, it was necessary to translate the sequencies of question-answer for the general public into current European Portuguese and, on the other hand, the sequencies of question-answer for public health professionals into medical specialized language.
O presente relatório lida fundamentalmente com questões semânticas decorrentes da tradução de Medication Safety in Pregnancy and Breastfeeding The Evidence Based A-to-Z Clinician's Pocket Guide, da autoria de Gideon Koren, cuja escolha foi motivada pela escassez de obras traduzidas para Português Europeu na área da medicina. Registe-se que grande parte do material nesta área foi traduzido para Português do Brasil, forçando assim médicos e estudantes da área de ciências médicas a recorrerem a estas traduções ou, em último caso, aos originais em língua estrangeira. Em qualquer dos casos, uma vez que os profissionais de saúde portugueses têm competências muitas vezes reduzidas ou nulas em línguas estrangeiras, e em virtude das acentuadas divergências entre o Português Europeu e a variedade do Português do Brasil, nenhuma das soluções é perfeita. Deste modo, este projecto de tradução prontifica-se, de algum modo, a minimizar a escassez de textos científicos traduzidos para Português Europeu. A questão central deste relatório prende-se com a tradução dos textos para dois registos diferentes, tendo em conta que a obra se dirige quer a profissionais de saúde pública quer ao público em geral. Assim, por um lado, foi necessário traduzir as sequências de pergunta-resposta da obra destinadas ao público em geral para Português Europeu corrente e, por outro, as sequências de perguntar - resposta destinadas a especialistas de saúde pública para a língua especializada da medicina.

Relatório de Estágio do Mestrado Integrado em Ciências Farmacêuticas apresentado à Faculdade de Farmácia
A fitoterapia tem sido usada ao longo de toda a história da humanidade, assim é normal que a utilização de plantas medicinais tenha passado de geração em geração para aliviar e tratar problemas de saúde. Nos dias de hoje a ciência tem capacidade de procurar os fundamentos teóricos que estão na origem desse uso tradicional, definir as indicações terapêutica, procurar os princípios ativos, estudar os mecanismos de ação, estabelecer as doses terapêuticas, prever interações com fármacos ou outras plantas, e investigar os efeitos secundários da utilização de plantas medicinais. Durante a gravidez a mulher passa por grandes alterações e experiencia sintomas causados pela própria gravidez. Para satisfazer as necessidades desta fase davida procura recursos que a ajudem. Numa tentativa de ter uma abordagem mais natural e mais segura sobre esta fase da sua vida procura plantas medicinais como uma solução. Nomeadamente o Zingiber officinale, o Vaccinium macrocarpon, a Vitis vinífera, o Prunus dulcis, a Valeriana officinalis, o Hypericum perforatum, o Ricinus communis, a Rubus idaeus, o Silybum marianum, e a Trigonella foenum-graecum. Contudo, as plantas medicinais podem provocar problemas na saúde e no desenvolvimento do seu bebé, como também problemas na sua própria saúde. Desta forma é necessário fornecer mais informação sobre este tema às grávidas e às mulheres em período de amamentação. Para isso também é preciso transmitir a informação já existente aos profissionais de saúde, e continuar a investigar acerca do uso de plantas medicinais na gravidez. Apenas o conhecimento nesta área pode prevenir e evitar consequências adversas para a mãe e para o bebé.
Phytotherapy has been used throughout human history, so it is normal that the use of medicinal plants has passed from generation to generation to alleviate and treat health problems. Nowadays, science has the capacity to search for the theoretical foundations behind this traditional use, to define therapeutic indications, to search for active principles, to study the mechanisms of action, to establish therapeutic doses, to predict interactions with drugs or other plants, and investigate the side effects of the use of medicinal plants. During pregnancy the woman undergoes major changes and suffers from some symptoms caused by the pregnancy itself. To meet the needs of this phase of life they look for resources to help them. In an attempt to take a more natural and safer approach on this phase of life they look at medicinal plants as a solution. In particular, Zingiber officinale, Vaccinium macrocarpon, Vitis vinifera, Prunus dulcis, Valeriana officinalis, Hypericum perforatum, Ricinus communis, Rubus idaeus, Silybum marianum, and Trigonella foenum-graecum. However, medicinal plants can cause problems in the health and development of the baby, as well as problems in the mother’s health. It is therefore necessary to provide more information on this topic to pregnant women and to breastfeeding women. For this, it is also necessary to transmit the information already available to health professionals, and to continue the investigation in the use of medicinal plants in pregnancy. Only knowledge in this area can prevent and avoid adverse consequences for the mother and the baby.

Social security of women during pregnancy and maternity and protection of their work Abstract The diploma thesis deals with the security of women during pregnancy and motherhood and the safety of their work. The whole work illustrates the development of social security in the Czech Republic, in particular the current situation of social security with the main focus on pregnant women and parents taking care of their children. The diploma thesis is divided into four chapters. The first chapter deals with the historical development of social security in the territory of the Czech Republic, in particular the development in the 20 century which is decisive for the current state of social security in the Czech Republic. The second chapter focuses on the international context of social security. The Czech Republic is a member state of several international organisations whose legislation has a significant impact on our social area. Therefore, this chapter is also devoted to international organisations and international law regulations focused on the social area, in particular on the rights of social security. The third chapter, which is the most extensive, is dedicated to the social security of women during pregnancy and motherhood. It deals with the security arising from both the sickness insurance system and the...

This dissertation presents three separate studies exploring parents’ perceptions and recommendations for communicating with their third, fourth, and fifth grade children about human sexuality. First, a systematic literature review is presented summarizing past qualitative studies completed in the United States focusing on parents with children aged 18 years and under. This review summarizes (1) demographic information of parents from past studies, (2) perceived communication barriers experienced by parents regarding sexuality communication, and (3) perceived communication facilitators experienced by parents regarding sexuality communication. Second, noting the lack of research within a specific population of parents in the United States, a naturalistic study of parents with children in the third, fourth, and fifth grade is presented. Utilizing an emergent design, one-on-one interviews were conducted with 20 parents living in a town in central Texas. By coding collected data, a thematic analysis was used to summarize emergent themes. Themes included techniques parents utilized to have parent-child conversations about sexuality and discussed topics. Although different techniques and topics were raised, parents showed overall inconsistency in experiences or past discussions. Third, using data from the same 20 interviews, themes emerged from parents regarding recommendations. These included the recommendations that a booklet with age appropriate information on sexuality topics be developed for parents and parent workshops or classes covering age appropriate sexuality knowledge as well as techniques to use in parent-child communication be offered. Schools were the recommended source for these resources. Parents also shared feedback on the newly released National Sexuality Education Standards. Comparing past parent-child conversations on sexuality topics to the NSES, certain topics were discussed yet inconsistency was shown. In addition, parents disagreed on specific standards including those pertaining to the functions of reproductive parts, reproduction, and same sex orientation. Implications of this study are that parental resources are needed to help parents communicate with their children about sexuality beginning at a young age. And, for those resources already existing, including workshops, books, and on-line sources, parents need to be made aware of their existence. In addition, future research is needed to explore if younger children are learning from parent-child conversations about sexuality.

This thesis was funded by the Department of Human Services (South Australia) to test the acceptability of nicotine patches to pregnant women and to assess the safety of nicotine patches for pregnant women, at least in terms of overall exposure to nicotine. The study was conducted in the antenatal clinics at the Women's and Children's Hospital, Adelaide and was a pilot for a planned larger study. If the pilot indicated that the nicotine patches could be used safely by this group of women, the larger study would examine the effectivemess of patches in a smoking cessation program. Four focus groups, three with pregnant women and one with their care providers, were used to elucidate issues for pregnant women related to smoking and the use of nicotine patches to aid cessation.

Objective: To determine if paternal preconception exposure to ionizing radiation through uranium mining increases the risk of congenital anomaly (CA) in offspring. Methods: A population-based matched case-control study was conducted. Cases were infants with CAs recorded in the Canadian Congenital Anomalies Surveillance System and born alive in Ontario 1979-86 (ICD-9 codes 740-759); controls were liveborn infants without CAs identified from Ontario birth certificates and individually matched to cases (case-control file {CCF}). Exposed fathers were identified through the linkage of the CCF to the Mining Master File or the National Dose Registry file, which include those who worked in Ontario uranium mines 1952-1986. For men who linked with a case or control child, radon, gamma and total gonadal doses were estimated for three preconception periods: entire, 3-months and 6-months. Odds ratios were estimated using conditional logistic regression. Results: Linkage of 28,991 uranium miners and 40,482 case-control pairs of fathers and offspring in the CCF identified 431 discordant pairs. There was no evidence of increased risk of a child having a CA if the father was ever a uranium miner before conception of the child (OR=0.89, 95% CI=0.74–1.08). Since gamma radiation (especially during the 6-month preconception period) is more biologically relevant to gonads than radon, further analyses were performed on 117 discordant pairs where data on gamma exposures were available. When ever/never miner, exposed to gamma (yes/no), and gamma dose-response variables were all in the model, there was no ever/never miner effect (OR=1.20, 95% CI=0.85–1.69, p-value=0.30), an inverse association for exposure to gamma (OR=0.42, 95% CI=0.25–0.71, p-value=0.001), but most importantly, there was no statistically significant dose-response relationship between gamma dose during the 6-month preconception period and all CAs (OR=1.15 per loge {mSv+0.01}, 95% CI=0.83–1.59, p-value=0.40). Similarly, no dose-response relationship was observed for exposure to gamma radiation in the 3-month preconception period, or for radon or total gonadal radiation in the 3- or 6-month preconception periods. Conclusion: There was no increased risk of a CA among liveborn children of Ontario uranium miners who were exposed to radon, gamma or total radiation during the 3- or 6-month periods before conception.

Trabalho Final do Mestrado Integrado em Medicina apresentado à Faculdade de Medicina
Introduction: Caffeine is a widely consumed stimulant that can be found in a range of beverages such as coffee, tea, chocolate, and even some medicine, which makes it easily ingested in considerable amounts during pregnancy. This stimulant can freely transfer across all biological membranes, including the blood–placental barrier. The main enzyme involved in caffeine metabolism (cytochrome P450 1A2) is absent in both the placenta and the fetus. Therefore, the fetus depends on maternal caffeine metabolism. However, throughout gestation, there is a delayed maternal clearance of caffeine, and the rate of caffeine metabolism decreases progressively from the first to the third trimester. Consequently, the fetus is exposed to caffeine and its metabolites for a prolonged period, which can lead to caffeine accumulation in fetal tissues and leaves neonates at risk of adverse outcomes.Several authors of observational studies established an association between maternal caffeine intake and adverse fetal, neonatal, and pregnancy outcomes. Nevertheless, conflicting results found in the literature make it difficult for health professionals to advise pregnant women about avoiding caffeine during pregnancy, since the precise level of intake above which the risk increases, remains unknown.Aims: We aimed to systematically review the published literature on the effects of caffeine intake by mother on fetal, neonatal and pregnancy outcomes with the purpose to establish a safe quantity of caffeine that could be ingested during gestational period, without increasing the risk of adverse outcomes.Methods and results: We systematically searched PubMed, EMBASE, and Web of Science on 27, 29, and 31 of January, respectively. The search was limited by language (English and Portuguese), type of subjects (human) and in time (since 1990, in the last 30 years). We searched for articles that related maternal caffeine consumption with fetal, neonatal and pregnancy outcomes under analyses (spontaneous abortion, stillbirth, low birth weight, intrauterine growth restriction, small for gestational age, preterm birth, congenital anomalies, SIDS and gestational diabetes mellitus). A total of 57 studies were included in the review; only 46 were included in the meta-analyses. We conducted a meta-analysis using a random-effects model (heterogeneity evaluated by Higgins e Thompson I2) and selected as a final result the model that separated further cases and control groups, being the one who presented a lower p-value. According to the results, the absence of caffeine consumption seems to increase the chance of occurrence of events such as spontaneous abortion (5 times), intrauterine growth restriction (4 times), small for gestational age (11 times), preterm birth (6 times) or congenital anomalies (43 times); therefore, we can infer that caffeine consumption may have a protective effect on the occurrence of those events in pregnant women and newborns. Additionally, we verified that a maternal caffeine intake higher than 200 mg/day seems to increase the risk of intrauterine growth restriction and congenital anomalies. A caffeine consumption above 300 mg/day also appears to enhance spontaneous abortion and small for gestational age events. Caffeine intake beyond 400 mg/day seems to increase the risk of low birth weight and preterm birth by more than ten times (10. 061 and 12. 825 on average, respectively).Conclusion: According to these results, the ingestion of caffeine until 200 mg/day is secure and protective.KEYWORDS: CAFFEINE; COFFEE; PREGNANCY; PERINATAL OUTCOME; MATERNAL CONSUMPTION;
Introdução: A cafeína é um estimulante encontrado no café, chá, chocolate e até em alguns medicamentos, pelo que acaba por ser facilmente consumida em grande quantidade por gestantes.A placenta é permeável à cafeína precocemente na gestação. No entanto, a principal enzima responsável pela metabolização da cafeína (citocromo P450 1A2) está ausente quer na placenta quer no feto. Devido à redução da atividade da enzima hepática que a metaboliza, bem como devido à redução da sua clearance durante a gravidez, a semi-vida da cafeína está significativamente aumentada no organismo de uma mulher grávida. Este facto combinado com a imaturidade hepática fetal que retarda a excreção deste metabolito, pois está dependente da metabolização materna, tornam prolongada a exposição do feto a este estimulante pelo que a probabilidade de existirem repercussões no desenvolvimento fetal aumenta. Vários estudos observacionais associam o consumo materno de cafeina durante a gestação ao aumento do risco de aborto espontâneo, morte fetal, parto pré-termo, restrição do crescimento intrauterino, baixo peso ao nascimento, recém-nascido pequeno para a idade gestacional, anomalias congénitas, síndrome de morte súbita e diabetes gestacional. Os resultados da literatura divergem relativamente a esta temática e, como tal, atualmente existe ainda alguma ambiguidade quanto ao aconselhamento da grávida relativamente à quantidade de cafeína que é seguro consumir durante a gravidez. Objetivo: O objetivo deste trabalho é rever a literatura publicada que relaciona o consumo materno de cafeína com as diferentes consequências a nível fetal, neonatal e na gestação e, consequentemente, estabelecer a quantidade segura de cafeína que a grávida pode consumir sem que o risco seja significativo.Métodos e Resultados: Para cumprir o objetivo proposto, realizamos uma pesquisa sistemática de artigos nas bases de dados Pubmed, Web of Science e EMBASE que relacionam o consumo materno de cafeína com os eventos fetais, neonatais e gestacionais incluídos na revisão (aborto espontâneo, morte fetal, baixo peso ao nascimento, restrição do crescimento intrauterino, recém nascido pequeno para idade gestacional, parto pré-termo, anomalias congénitas, síndrome de morte súbita e diabetes gestacional). A pesquisa realizada incluiu os artigos publicados nos últimos 30 anos em inglês e português. Após esta abordagem inicial, os artigos foram selecionados de acordo com a pertinência do título e do resumo, tendo sido excluídos aqueles que não se enquadravam no âmbito desta revisão. Posteriormente, procedeu-se a uma leitura integral dos artigos restantes. De 1002 artigos inicialmente identificados, 57 foram incluídos na revisão sistemática e apenas 46 na meta análise. Realizamos uma meta análise usando um modelo de efeitos aleatórios, dado que é esperada elevada heterogeneidade entre os estudos (avaliada pelo I2 de Higgins e Thompson), para cada um dos possíveis pontos de corte de consumo de cafeína tendo sido selecionado como resultado final o modelo com maior significância estatística. Este procedimento foi repetido para cada um dos 9 eventos considerados.De acordo com os resultados, o consumo materno de cafeína aparenta ter um efeito protetor na ocorrência de eventos, sendo que a ausência de consumo de cafeína parece aumentar o risco de ocorrência de aborto espontâneo (5 vezes), restrição do crescimento intrauterino (4 vezes), recém-nascido pequeno para a idade gestacional (11 vezes), parto pré-termo (6 vezes) ou anomalias congénitas (43 vezes).Contudo, este efeito protetor não é independente do nível de consumo, uma vez que simultaneamente verificamos que um consumo materno de cafeína superior a 200 mg/dia parece potenciar o risco de restrição de crescimento intrauterino e anomalias congénitas, superior a 300 mg/dia parece aumentar o risco de aborto espontâneo e de um recém-nascido pequeno para a idade gestacional, e consumos de cafeína acima de 400 mg/dia parecem aumentar o risco de baixo peso ao nascimento e parto pré-termo em mais de 10 vezes (respetivamente 10,061 e 12,825). Conclusão: De acordo com a metodologia utilizada, um consumo materno de cafeína até 200 mg/dia é seguro e parece ser simultaneamente protetor. PALAVRAS-CHAVE: CAFEÍNA; CAFÉ; GRAVIDEZ; CONSEQUÊNCIAS PERINATAIS; CONSUMO MATERNO;

University of Technology Sydney. Faculty of Health.
Aim: The aim of this project is to explore the use of complementary and alternative medicine (CAM) products and services by women during pregnancy, with a focus upon: determining the current prevalence of CAM use and examining the determinants, characteristics and attitudes of women who use CAM; investigating the utilisation of various information sources used by pregnant women to make decisions about the use of CAM; and examining the extent to which pregnant women choose to self-prescribe certain CAM products. Method: The study sample was obtained via the Australian Longitudinal Study on Women’s Health (ALSWH). The ALSWH is a longitudinal study of women in three age groups (“young” 18-23, “mid age” 45-50 and “older” 70-75 years), who were randomly selected from the Australian national Medicare database to investigate multiple factors affecting health and wellbeing of women over a 20-year period. This research project analyses data from a sub-study survey administered in 2010. Participants in the sub-study were identified based upon their reporting of being pregnant or as having recently given birth in the 2009 ALSWH Survey 5 (n=2,316) of the young cohort. A total of 1,835 women responded to the sub-study survey and were included in the analysis (79.2% response rate). Results: CAM use during pregnancy is high with 91.7% (n=1,485) of women using a CAM product (52.0% excluding vitamins and minerals) and 48.1% (n=623) of women consulting a CAM practitioner. CAM practitioner visits were more likely for selected pregnancy-related health concerns, namely back pain or backache, and neck pain. Employment was also found to be predictive of pregnant women’s visits to a CAM practitioner. Significant health history and demographic predictors of CAM product use were tiredness and fatigue, embarking on preparation for labour and having a university education. Further analysis found that of the 447 women who did consult a CAM practitioner prior to pregnancy 62.4% (n=279) continued to utilise a CAM practitioner during pregnancy. Certain attitudes were found to be associated with women who use CAM products during pregnancy and women were more likely to use herbal medicine if they suffered from anxiety, sleeping problems and/or fatigue. The self-prescription of herbal medicine was also found to be widespread. Of the women deciding whether or not to visit a CAM practitioner, nearly half (48%, n=493) were influenced by their own personal experience of CAM and 43% (n=423) by family and friends. Conclusion: CAM use by women during pregnancy is high. Maternity health care professionals need to inquire about CAM use during routine antenatal visits in order to ensure safe maternal outcomes.

Effective case management of malaria is hampered by the spread of parasite resistance to nonartemisinin antimalarials. To counteract the impact of drug resistance, the World Health Organization (WHO) has endorsed artemisinin-based combination therapy (ACT) as the first-line treatment for uncomplicated Plasmodium falciparum malaria. Currently recommended ACTs are artemether-lumefantrine, artesunate plus amodiaquine, artesunate plus mefloquine, artesunate plus sulfadoxine-pyrimethamine and dihydroartemisinin-piperaquine. This study sought to review evidence of the efficacy and safety of different non-artemisinin antimalarials in combination with artesunate, artemether or dihydroartemisinin for the treatment of uncomplicated P. falciparum malaria in non-pregnant adults and children. The search for randomized controlled trials (RCTs) was conducted in the Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, EMBASE and in ClinicalTrials.gov in January 2009. The eligibility and the methodological quality of trials were assessed and data were extracted, using standard forms. Data were captured and analyzed in Review Manager Software, versions 4.2 and 5.0. The outcomes assessed were: treatment failure, fever and parasite clearance time, calculating the relative risk (RR) and a weighted mean difference (WMD) with a 95% confidence interval and p-values, indicating statistical significance at 0.05. Thirty-seven trials with 6862 participants were included. Artesunate combined with amodiaquine had a statistically significant lower risk of treatment failure compared to the combination of artesunate with sulfadoxine-pyrimethamine (RR=0.57, 95% CI [0.33, 0.97], p=0.04, seven trials, N=1341). In addition, treatment with artesunate plus mefloquine was significantly associated with a lower risk of treatment failure compared to artesunate plus azithromycin (RR=0.04, 95% CI [0.00, 0.64], p=0.02, one trial, N=54). There was no significant difference when either mefloquine or atovaquone-proguanil were combination partners with artesunate (RR=2.6, 95% CI [0.93; 7.24], p=0.07, one trial, N=1066). When artesunate was combined with chloroquine, primaquine or azithromycin and compared with artesunate monotherapy, there was no statistically significant difference in the risk of unadjusted treatment failure. Each of these comparisons had one trial each. Artesunate plus chloroquine was quicker at clearing fever compared to artesunate plus sulfadoxinepyrimethamine (WMD= -7.20, 95% CI [-12.53, -1.87], one trial, N=132). Few trials adequately reported adverse events. There was no significant difference observed in the risk of adverse events between artesunate plus amodiaquine compared with artesunate monotherapy, however, adverse events were significantly less in artesunate plus amodiaquine compared to artesunate plus methylene-blue. Artesunate plus amodiaquine on the other hand had significantly more adverse events reported compared to artesunate plus sulfadoxine-pyrimethamine. The findings of this study support the implementation of artemisinin-based combination therapy for the treatment of uncomplicated malaria. Most crucially, this review found a greater advantage of combining amodiaquine with artesunate compared to sulfadoxine-pyrimethamine. The efficacy of artesunate plus mefloquine was superior to that of artesunate plus azithromycin. Furthermore, the combination of artemisinins with chloroquine, primaquine and azithromycin has shown very low efficacy and these combination therapies should not be recommended. The reporting of efficacy was not standardized as many trials did not differentiate between re-infections and recrudescences. Adverse events were also not adequately reported.
Thesis (M.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2011.

This study identified pregnancy-related challenges encountered by student nurses at SAMHS Nursing College, with an aim of identify factors contributing to student nurses' pregnancies as well as finding ways to deal and minimize the rate of the pregnancies amongst the student nurses. Thirty (30) structured interviews were conducted with student nurses who were pregnant and those who delivered their babies during the period 2002 to 2007. It has been revealed that ignorance is the major contributing factor for student nurses' pregnancies, 63% of the pregnancies were not planned, 52% of the respondents related their pregnancies to risk taking as they engaged in unprotected sex without the use of contraceptives, and thus it was concluded that student nurses are engaging themselves in risk behaviours and also engaging in unsafe sexual practices. The study also found that student nurses face physical, social, emotional as well as academic problems during pregnancy and after the delivery of their babies. Student nurses should be encouraged to use condoms and other methods of contraception, coupled with educating them on life skills, provision of recreational facilities; provision of counseling and support services may be the tool to minimise the unplanned pregnancies.
Health Studies
(M.A.(Public Health ))

The aim of the study was to explore the perceptions of the HIV negative pregnant women, after their hiv negative results, towards preventive sexual behaviour. Methodology: A qualitative approach was used in exploring the perceptions of hiv negative pregnant women and describing their behaviour according to the findings. Fifteen participants were interviewed. Two semi - structured interviews were conducted with each participant, an initial interview and a verifying interview, for the purpose of saturation and verification. Each interview lasted for 20 - 30 minutes. The interviews were recorded and transcribed. Manual data analysis was used to identify categories and themes. Findings: The study revealed that the participants knew what the negative status entailed. They were also aware that there is a chance of hiv negative person being infected by hiv virus if they do not engage in preventive sexual behaviour. Furthermore, they had also disclosed their hiv negative status to their partners and most of the partners refused to go for testing. Though the participants believed that it was necessary to use condoms even if they were hiv negative, most of them had not use condoms during their last sexual intercourse. Reasons for not engaging in preventive sexual behaviour were revealed by the study. Recommendations were suggested for clinical practice, nursing education, management and research.
Thesis (M.A.)-University of KwaZulu-Natal, Durban, 2005.

The purpose of this study was to analyse and describe the factors that influence the choice of site of delivery by pregnant women in Mukono district. By employing quantitative, non experimental research methods, 431 women were interviewed by using structured questionnaires. These women had either delivered at; home, TBA, private or public clinic and 72% had been delivered by skilled attendants. Choice of delivery site was influenced by the attitudes of health workers which were rather poor in public sites, proximity of site, attendance of antenatal clinic at a site, availability of supplies and drugs, plus level of care including emergency obstetric care.
Health Studies
M. A. (Public Health)

Research Doctorate - Doctor of Philosophy (PhD)
In the last decade, there has been improvement in the life expectancy of people living with HIV due to improved drug therapy and care and support programs. Improved health and survival allows women living with HIV (WLHIV) to provide and care for their families. Importantly, WLHIV who intend to have children need information and services focused on safe conception strategies while those who do not desire a child need access to effective contraceptive methods. However, fertility rates, contraceptive use and reproductive plans among this population are largely unknown, as are the ways in which practitioners and WLHIV might discuss fertility. This thesis therefore aimed to assess fertility, contraceptive use and client-provider discussions regarding reproductive plans among WLHIV in western Ethiopia. A multi-method approach comprising of a systematic review, a cross-sectional survey and qualitative study was used. The first aim was to determine the magnitude of unintended pregnancies in WLHIV in sub-Saharan Africa and to summarise findings on factors associated with unintended pregnancies among these women. A high magnitude of unintended pregnancy was found (55.9%) and unintended pregnancy was significantly higher among women living with HIV than for women who do not have HIV. The remaining four aims were based on original data. A facility-based cross-sectional survey was conducted in 2018 among 1,082 reproductive-aged (15-49 years) WLHIV in western Ethiopia. The second aim was to examine fertility (defined as live births) and its associated factors among WLHIV in western Ethiopia in the last 3 years. A total of 12.5% of WLHIV in Ethiopia reported having children in the last 3 years. Among these, 18.2% of pregnancies were reported as mistimed and 26.4% as unwanted suggesting that strengthening family planning programs for WLHIV is important. The third aim was to assess contraceptive use among sexually active WLHIV in western Ethiopia. Among sexually active WLHIV who reported being fecund and sexually active within the previous six months but not wanting to have another child within the next two years (n=360), 75% used contraception and 25% had an unmet need for contraception. Compared to women having no children after HIV diagnosis, having two or more children after HIV diagnosis was associated with increased use of contraception. However, sexually active unmarried women were less likely to use contraception compared to their sexually active married counterparts. Importantly, WLHIV who reported high and medium perceived susceptibility towards pregnancy were associated with higher prevalence of contraceptive use than WLHIV with low perceived susceptibility. The fourth aim assessed discussions between healthcare providers and sexually active WLHIV in western Ethiopia regarding their reproductive plans. Among sexually active WLHIV (n=475), 30.7% reported having had a general discussion regarding pregnancy and HIV with healthcare providers. However, only 16.8% of WLHIV had discussions with their providers regarding their personal reproductive plans. Unmarried sexually active women and women accessing health centers for antiretroviral therapy (ART) were less likely to report both general and personalized discussions than married women and women who accessed ART through hospitals, respectively. Following this, the fifth aim used a qualitative approach to gain deeper insights into the perceptions surrounding fertility plan discussions between WLHIV in western Ethiopia and their healthcare providers. Thirty-one interviews (27 with WLHIV and 4 with healthcare providers working at HIV clinics) were conducted. Training of healthcare providers regarding safer conception, non-judgmental counselling, improving the integration of services along with improved human resources, and improving partner involvement were found to be crucial to client-centered reproductive healthcare. Given WLHIV are both having and intending to have children, it is important to provide safe conception practices that eliminate or lower the chance of HIV being passed on to the child during pregnancy and childbirth. The findings in this thesis highlighted that the delivery of fertility plan discussions occur inconsistently and underscore the need for policy and provider-training in order to provide clear, consistent and sensitive reproductive counselling to WLHIV. Importantly, redirecting tasks such as fertility plan counselling to mother support groups and adherence counsellors could be used as a strategy for people to achieve safer conception. It is also important to strengthen family planning services given the high rate of unplanned pregnancies, and the high rate of unmet needs for contraception.

1 ABSTRACT The issue of births outside a medical facility is currently a controversial topic between specialists as well as in the public sector. While the specialists concur in refusing home births, the society is divided. There are voices that refuse home births but there are also plenty of people who support the right of mothers to give birth outside of a medical facility. Very sensitive topic is the legal and ethical aspects of the protection of unborn children and the issue of a safely conducted delivery. In the last decades, the life value of an unborn child has been seen as an ethical problem. The right to life is one of the fundamental human rights, which is enshrined in the constitutional system of the Czech Republic and also in the international human rights conventions. Because there are different opinions regarding this issue, it is necessary to establish a view that is widely accepted so that legal standards can be approved provided that the opinions of minorities are being respected. The main objective of this presented dissertation was to ascertain why are people losing confidence in a doctor's role during delivery and what is the reason for some of the mothers being unsatisfied with current institutional system of obstetrics. On the basis of these factual findings, which emerged during the...

Adolescent pregnancies are high risks obstetric occurrences. Antenatal care (ANC) provides opportunities to recognise and treat obstetric complications, enhancing the pregnancy outcomes for mothers and babies. This study investigated factors influencing pregnant adolescents' utilisation of ANC services in Bulawayo, using the Health Belief Model's major tenets. A quantitative descriptive design was used in four phases: 80 adolescents' ANC records were audited; structured interviews were conducted with 200 adolescents attending ANC and with 80 adolescents who had delivered their babies without attending ANC; and 52 midwives completed questionnaires portraying their perceptions on adolescents' utilisation of ANC services in Bulawayo. Documentation of ANC services provided to adolescents did not meet the expected standards. Poor or non utilisation of ANC services was influenced by socio demographic factors, individual perceptions of adolescents about antenatal care, perceived benefits of and perceived barriers to the utilisation of ANC. Most pregnant adolescents could not access these services because they could not pay the ANC and/or delivery fees charged at government clinics/hospitals. Midwives required more training in providing and recording adequate ANC services. Free ANC and delivery services could enhance adolescents' pregnancy outcomes in Zimbabawe. An information brochure on the importance of ANC attendance for adolescents has been compiled, based on the research results (see Annexure J).
Health Studies
D.Litt. et Phil. (Health Studies)