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1

HERBST, ANDREAS, and KARIN KÄLLÉN. "TERM BREECH DELIVERY." Fetal and Maternal Medicine Review 16, no. 4 (November 2005): 289–322. http://dx.doi.org/10.1017/s0965539505001634.

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In October 2000, Hannah et al published a randomised controlled trial comparing perinatal and maternal outcome between planned vaginal and planned caesarean deliveries of term breech pregnancies. The study was closed after an interim analysis, showing a reduced perinatal morbidity and mortality with planned caesarean section. The result was not unexpected, although a trial like this had been called for over many years to resolve the issue. Many cohort- and case-control studies, and two small randomised studies had been performed since 1959, when Wright reported a reduced perinatal mortality and morbidity with CS. A few large registry studies had shown a better perinatal outcome with caesarean delivery, whereas smaller studies often showed no statistically significant difference in outcome, often with the conclusion that vaginal delivery (VD) is safe.
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2

Semrau, Katherine EA, Kate A. Miller, Stuart Lipsitz, Jennifer Fisher-Bowman, Ami Karlage, Bridget A. Neville, Margaret Krasne, et al. "Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India." BMJ Global Health 5, no. 9 (September 2020): e002268. http://dx.doi.org/10.1136/bmjgh-2019-002268.

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BackgroundEvidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.MethodsWithin the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants’ practice adherence to perinatal mortality.FindingsAcross 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.InterpretationAdherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.FundingBill & Melinda Gates Foundation.Trial registration detailsClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.
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3

Green, Sheryl M., Eleanor Donegan, Randi E. McCabe, David L. Streiner, Arela Agako, and Benicio N. Frey. "Cognitive behavioral therapy for perinatal anxiety: A randomized controlled trial." Australian & New Zealand Journal of Psychiatry 54, no. 4 (January 20, 2020): 423–32. http://dx.doi.org/10.1177/0004867419898528.

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Background: Up to one in five women meet diagnostic criteria for an anxiety disorder during the perinatal period (i.e. pregnancy and up to 1 year postpartum). While psychotropic medications are effective, they are associated with risks for mothers and babies. There is a growing demand for evidence-based non-pharmacological treatments for perinatal anxiety. Objective: To evaluate the effectiveness of a cognitive behavioral group therapy protocol for perinatal anxiety. Methods: In total, 96 women were randomized to cognitive behavioral group therapy or waitlist at a clinic specializing in women’s mental health. Participants were 22–41 years of age, pregnant or up to 6 months postpartum and had an anxiety disorder with or without comorbid depression. Results: Compared to waitlist, participants in cognitive behavioral group therapy reported significantly greater reductions in the primary outcome of anxiety (State-Trait Inventory of Cognitive and Somatic Anxiety, η2p = .19; Hamilton Anxiety Rating Scale, η2p = .16), as well as in secondary outcomes including worry (Penn State Worry Questionnaire, η2p = .29), perceived stress (Perceived Stress Scale, η2p = .33) and depressive symptoms (Edinburgh Postnatal Depression Scale, η2p = .27; Montgomery–Åsberg Depression Rating Scale, η2p = .11). Maternal status (pregnant, postpartum) and medication use were unrelated to treatment outcomes. All gains were maintained, or continued to improve, at 3-month follow-up. Conclusion: Cognitive behavioral group therapy was effective in improving anxiety and related symptoms among women with anxiety disorders in the perinatal period.
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4

Brocklehurst, P. "Role of external evidence in monitoring clinical trials: experience from a perinatal trial." BMJ 320, no. 7240 (April 8, 2000): 995–98. http://dx.doi.org/10.1136/bmj.320.7240.995.

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5

Minchin, Maureen. "Infant Formula: A Mass, Uncontrolled Trial in Perinatal Care." Birth 14, no. 1 (March 1987): 25–35. http://dx.doi.org/10.1111/j.1523-536x.1987.tb01445.x.

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6

FIELD, D. "Evidence in perinatal medicine: enough of trial and error?" Archives of Disease in Childhood - Fetal and Neonatal Edition 81, no. 3 (November 1, 1999): F161. http://dx.doi.org/10.1136/fn.81.3.f161.

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7

Haga, Silje Marie, Filip Drozd, Carina Lisøy, Tore Wentzel-Larsen, and Kari Slinning. "Mamma Mia – A randomized controlled trial of an internet-based intervention for perinatal depression." Psychological Medicine 49, no. 11 (September 7, 2018): 1850–58. http://dx.doi.org/10.1017/s0033291718002544.

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AbstractBackgroundStudies suggest that 10–15% of perinatal women experience depressive symptoms. Due to the risks, problems with detection, and barriers to treatment, effective universal preventive interventions are needed. The aim of this study was to assess the effectiveness of an automated internet intervention (‘Mamma Mia’) on perinatal depressive symptoms. Mamma Mia is tailored specifically to the perinatal phase and targets risk and protective factors for perinatal depressive symptoms.MethodsA total of 1342 pregnant women were randomized to an intervention (‘Mamma Mia’) and control group. Data were collected at gestational week (gw) 21–25, gw37, 6 weeks after birth, and 3 and 6 months after birth. We investigated whether (1) the intervention group displayed lower levels of depressive symptoms compared with the control group, (2) the effect of Mamma Mia changed over time, (3) the effect on depressive symptoms was moderated by baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time. Finally, we examined if the prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10] differed between the intervention and control group.ResultsParticipants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) = 7.03, p = 0.008]. There were indications that the effect of Mamma Mia was moderated by EPDS score at baseline. The prevalence of women with EPDS-score ⩾10 was lower in the Mamma Mia group at all follow-up measurements.ConclusionsThe study demonstrated the effects of the automated web-based universal intervention Mamma Mia on perinatal depressive symptoms.
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8

Johnson, Jennifer E., Ann B. Price, Alla Sikorskii, Kent D. Key, Brandon Taylor, Susan Lamphere, Christine Huff, Morgan Cinader, and Caron Zlotnick. "Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss." BMJ Open 12, no. 4 (April 2022): e057747. http://dx.doi.org/10.1136/bmjopen-2021-057747.

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IntroductionThis protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss.Methods and analysisA sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode.Ethics and disseminationThe trial was approved by Michigan State University’s Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request.Trial registration numberNCT04629599.
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9

Kirton, A., J. Andersen, M. Herrero, L. Carsolio, A. Nettel-Aguirre, A. Mineyko, and M. Hill. "Brain stimulation and constraint for hemiparesis after perinatal stroke: The PLASTIC CHAMPS trial." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 42, S1 (May 2015): S8. http://dx.doi.org/10.1017/cjn.2015.67.

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Background: Perinatal stroke causes hemiparetic cerebral palsy. Constraint therapy (CIMT) improves function in congenital hemiparesis and adult stroke. Repetitive transcranial magnetic stimulation (rTMS) may improve function in adult stroke. The two have not been tested in perinatal stroke. Methods: PLASTIC CHAMPS (www.clinicaltrials.gov/NCT01189058) was a controlled factorial trial of rTMS and CIMT in perinatal-stroke hemiparesis. Children 6-18 years participated in a 2 week peer-supported motor learning camp, randomized to daily inhibitory rTMS (1200 stimulations, contralesional M1), CIMT, both or neither. Primary outcomes were Assisting Hand Assessment (AHA) and Canadian Occupational Performance Measure (COPM) at 1, 8, and 24 weeks. Quality-of-life, safety and tolerability were evaluated. Change was assessed across treatment groups over time (linear mixed effects model). Results: All forty-five subjects completed the trial (median 11.4yrs). COPM scores increased >100% with maximal gains at 6 months (p<0.002). Addition of rTMS and/or CIMT doubled the chances of clinically significant gains. Combined rTMS+CIMT resulted in larger AHA gains at all time points (6 months p=0.006). CIMT or rTMS alone had more modest effects. Neither treatment decreased function in either hand. Procedures were well tolerated. Conclusions: Children with hemiparesis participating in intensive, psychosocial rehabilitation programs perceive marked increases in function. Non-invasive brain stimulation may enhance motor learning therapy in perinatal stroke hemiparesis.
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10

Sun, Yaoyao, Yanyan Li, Juan Wang, Qingyi Chen, Alessandra N. Bazzano, and Fenglin Cao. "Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial." Journal of Medical Internet Research 23, no. 1 (January 27, 2021): e23410. http://dx.doi.org/10.2196/23410.

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Background Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. Objective The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. Methods Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. Results A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, –0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001). Conclusions Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. Trial Registration Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474
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11

Nielsen, Peter E. "Group Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial." Obstetrics & Gynecology 111, no. 4 (April 2008): 993. http://dx.doi.org/10.1097/aog.0b013e31816bf4be.

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12

Ickovics, Jeannette R. "Group Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial." Obstetrics & Gynecology 111, no. 4 (April 2008): 993–94. http://dx.doi.org/10.1097/aog.0b013e31816bf6bd.

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13

Chapman, R. L. "Group Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial." Yearbook of Neonatal and Perinatal Medicine 2008 (January 2008): 279–81. http://dx.doi.org/10.1016/s8756-5005(08)79139-x.

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Ickovics, Jeannette R., Trace S. Kershaw, Claire Westdahl, Urania Magriples, Zohar Massey, Heather Reynolds, and Sharon Schindler Rising. "Group Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial." Obstetrical & Gynecological Survey 62, no. 12 (December 2007): 766–67. http://dx.doi.org/10.1097/01.ogx.0000291206.41258.c7.

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15

Healy, Andrew, Fergal Malone, Gina Peloso, Robert Ball, David Luthy, Christine H. Comstock, Radek Bukowski, et al. "Racial disparity in perinatal mortality - results from the FASTER trial." American Journal of Obstetrics and Gynecology 191, no. 6 (December 2004): S125. http://dx.doi.org/10.1016/j.ajog.2004.10.335.

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16

Berrigan, Patrick, Jacquie Hodge, Adam Kirton, Myla E. Moretti, Wendy J. Ungar, and Jennifer D. Zwicker. "Protocol for a cost–utility analysis of neurostimulation and intensive camp-based therapy for children with perinatal stroke and hemiparesis based on a multicentre clinical trial." BMJ Open 11, no. 1 (January 2021): e041444. http://dx.doi.org/10.1136/bmjopen-2020-041444.

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Introduction Perinatal stroke leads to cerebral palsy (CP) and lifelong disability for thousands of Canadian children. Hemiparesis, referring to impaired functionality in one side of the body, is a common complication of perinatal stroke. Standard long-term care for hemiparetic CP focuses on rehabilitation therapies. Early research suggests that patients with hemiparesis may benefit from adjunctive neuromodulation treatments such as transcranial direct current stimulation (tDCS). tDCS uses electric current to stimulate targeted areas of the brain non-invasively, potentially enhancing the effects of motor learning therapies. This protocol describes an economic evaluation to be conducted alongside a randomised controlled trial (RCT) to assess the incremental cost of tDCS added to a camp-based therapy compared with camp-based therapy alone per quality-adjusted life year (QALY) gained in children with hemiparetic CP. Methods and analysis The Stimulation for Perinatal Stroke Optimising Recovery Trajectories (SPORT) trial is a multicentre RCT evaluating tDCS added to a 2-week camp-based therapy for children aged 6–18 years with perinatal ischaemic stroke and disabling hemiparetic CP affecting the upper limb. Outcomes are assessed at baseline, 1 week, 2 months and 6 months following intervention. Cost and quality of life data are collected at baseline and 6 months and results will be used to conduct a cost–utility analysis (CUA). The evaluation will be conducted from the perspectives of the public healthcare system and society. The CUA will be conducted over a 6-month time horizon. Ethics and dissemination Ethical approval for the SPORT trial and the associated economic evaluation has been given by the research ethics boards at each of the study sites. The findings of the economic evaluation will be submitted for publication in a peer reviewed academic journal and submitted for presentation at conference. Trial registration number NCT03216837; Post-results.
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Corbally, Linda, and Mick Wilkinson. "The Effect of Mindfulness-Based Interventions on Stress, Depression and Anxiety During the Perinatal Period in Women Without Pre-existing Stress, Depressive or Anxiety Disorders: a Systematic Review and Meta-analysis of Controlled Trials." Mindfulness 12, no. 10 (July 29, 2021): 2357–70. http://dx.doi.org/10.1007/s12671-021-01697-3.

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Abstract Objectives The objective of this systematic review and meta-analysis was to examine controlled trial evidence for the effectiveness of mindfulness-based interventions on stress, anxiety and depression in the perinatal period in women without pre-existing mental health issues. Methods Six databases were searched for studies exploring the effects of mindfulness-based interventions on mental health outcomes of women during the perinatal period. Quality of both controlled trial meeting inclusion criteria were assessed using a tool specifically designed for meta-analyses of mindfulness-based interventions. Effect sizes were extracted for measures of mindfulness, depression, stress and anxiety outcomes. Effects were pooled in separate meta-analyses for all outcomes except anxiety which lacked sufficient studies. Results Twelve studies were analysed. Pooled effects suggest that mindfulness-based interventions cause small but clear increases in mindfulness and reductions in depression in women without pre-existing disorders. Effects of mindfulness-based interventions on other outcomes were unclear and confounded by heterogeneity. Conclusions Available controlled trial evidence suggests that mindfulness-based interventions improve mindfulness and decrease symptoms of depression during pregnancy in women without pre-existing mental health issues and might be a useful approach to prevent or attenuate the development of depression in the perinatal period.
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Gureje, Oye, Bibilola D. Oladeji, Alan A. Montgomery, Ricardo Araya, Toyin Bello, Dan Chisholm, Danielle Groleau, et al. "High- versus low-intensity interventions for perinatal depression delivered by non-specialist primary maternal care providers in Nigeria: cluster randomised controlled trial (the EXPONATE trial)." British Journal of Psychiatry 215, no. 3 (February 15, 2019): 528–35. http://dx.doi.org/10.1192/bjp.2019.4.

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BackgroundContextually appropriate interventions delivered by primary maternal care providers (PMCPs) might be effective in reducing the treatment gap for perinatal depression.AimTo compare high-intensity treatment (HIT) with low-intensity treatment (LIT) for perinatal depression.MethodCluster randomised clinical trial, conducted in Ibadan, Nigeria between 18 June 2013 and 11 December 2015 in 29 maternal care clinics allocated by computed-generated random sequence (15 HIT; 14 LIT). Interventions were delivered individually to antenatal women with DSM-IV (1994) major depression by trained PMCPs. LIT consisted of the basic psychosocial treatment specifications in the World Health Organization Mental Health Gap Action Programme – Intervention Guide. HIT comprised LIT plus eight weekly problem-solving therapy sessions with possible additional sessions determined by scores on the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome was remission of depression at 6 months postpartum (EPDS < 6).ResultsThere were 686 participants; 452 and 234 in HIT and LIT arms, respectively, with both groups similar at baseline. Follow-up assessments, completed on 85%, showed remission rates of 70% with HIT and 66% with LIT: risk difference 4% (95% CI −4.1%, 12.0%), adjusted odds ratio 1.12 (95% CI 0.73, 1.72). HIT was more effective for severe depression (odds ratio 2.29; 95% CI 1.01, 5.20; P = 0.047) and resulted in a higher rate of exclusive breastfeeding. Infant outcomes, cost-effectiveness and adverse events were similar.ConclusionsExcept among severely depressed perinatal women, we found no strong evidence to recommend high-intensity in preference to low-intensity psychological intervention in routine primary maternal care.Declaration of interestsNone.
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Andrejek, Nicole, Sabrina Hossain, Nour Schoueri-Mychasiw, Gul Saeed, Maral Zibaman, Angie K. Puerto Niño, Samantha Meltzer-Brody, Richard K. Silver, Simone N. Vigod, and Daisy R. Singla. "Barriers and Facilitators to Resuming In-Person Psychotherapy with Perinatal Patients amid the COVID-19 Pandemic: A Multistakeholder Perspective." International Journal of Environmental Research and Public Health 18, no. 22 (November 22, 2021): 12234. http://dx.doi.org/10.3390/ijerph182212234.

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During the COVID-19 pandemic, outpatient psychotherapy transitioned to telemedicine. This study aimed to examine barriers and facilitators to resuming in-person psychotherapy with perinatal patients as the pandemic abates. We conducted focus group and individual interviews with a sample of perinatal participants (n = 23), psychotherapy providers (n = 28), and stakeholders (n = 18) from Canada and the U.S. involved in the SUMMIT trial, which is aimed at improving access to mental healthcare for perinatal patients with depression and anxiety. Content analysis was used to examine perceived barriers and facilitators. Reported barriers included concerns about virus exposure in a hospital setting (77.8% stakeholders, 73.9% perinatal participants, 71.4% providers) or on public transportation (50.0% stakeholders, 26.1% perinatal participants, 25.0% providers), wearing a mask during sessions (50.0% stakeholders, 25.0% providers, 13.0% participants), lack of childcare (66.7% stakeholders, 46.4% providers, 43.5% perinatal participants), general transportation barriers (50.0% stakeholders, 47.8% perinatal participants, 25.0% providers), and the burden of planning and making time for in-person sessions (35.7% providers, 34.8% perinatal participants, 27.8% stakeholders). Reported facilitators included implementing and communicating safety protocols (72.2% stakeholders, 47.8% perinatal participants, 39.3% providers), conducting sessions at alternative or larger locations (44.4% stakeholders, 32.1% providers, 17.4% perinatal participants), providing incentives (34.8% perinatal participants, 21.4% providers, 11.1% stakeholders), and childcare and flexible scheduling options (31.1% perinatal participants, 16.7% stakeholders). This study identified a number of potential barriers and illustrated that COVID-19 has fostered and amplified barriers. Future interventions to facilitate resuming in-person sessions should focus on patient-centered strategies based on empathy regarding ongoing risk-aversion among perinatal patients despite existing safety protocols, and holistic thinking to make access to in-person psychotherapy easier and more accessible for perinatal patients.
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Mehnaz, Syeda, MAK Azad Chowdhury, BH Nazma Yasmeen, Md Masudur Rahman, Rowshan Jahan Akter, Manifa Afrin, and Mahmuda Begum. "Role of Human Recombinant Erythropoietin (rHuEPO) in Perinatal Asphyxia-a randomized controlled trial." Northern International Medical College Journal 10, no. 1 (December 20, 2018): 330–34. http://dx.doi.org/10.3329/nimcj.v10i1.39326.

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Background : Perinatal asphyxia is an insult to the fetus or newborn infant due to lack of oxygen (hypoxia) and/or a lack of perfusion (ischemia) to various organs, which will manifest as difficulty in establishing spontaneous respiration evident by delayed cry after birth, at least after one minute. World-wide, perinatal asphyxia accounts for about 900,000 deaths each year. In Bangladesh it is a major cause of neonatal death. A substantial proportion of the children that survive suffer late effects such as cerebral palsy and epilepsy. Objective : To determine the efficacy of erythropoietin in improving the neurological outcome of term neonates with perinatal asphyxia (HIE stage II and III). Materials and methods : A Randomized Controll Trial was carried out in the Neonatal ward and NICU of Dhaka Shishu Hospital from 1st April 2014 to 30th Sep 2015. A total 68 neonates with perinatal asphyxia (both HIE stage II and III) who fulfill the inclusion criteria were enrolled and randomly assigned to intervention group (n=35) and control group (n=33). Intervention group received rHuEPO 300- 500 U/kg/dose daily subcutaneously for 5 days within first 48 hours of birth along with the standard treatment protocol and control group received standard treatment protocol only. Results : Baseline clinical characteristics, USG of brain during hospital stay were almost similar in both groups. Statistically significant effect was noted in seizure control, tolerance of oral feeding, hospital stay and neurological outcome at 3 months of age (p=008). USG of brain at 3 months of age also improved significantly (p=0.027). Conclusion : This study demonstrates the effectiveness of early administration of rHuEPO to term neonates with moderate to severe asphyxia, beneficial effect on short term outcomes like seizure control, tolerance of oral feeding and neurological outcome at 3 months of age. A large multicenter study would be done for further evaluation of these findings. Northern International Medical College Journal Vol.10(1) Jul 2018: 330-334
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Joshi, Shachi, Rutul Kapadia, and Ajesh Desai. "Impact of planned amniotomy on perinatal outcome: a randomized control trial." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 6, no. 7 (June 24, 2017): 2741. http://dx.doi.org/10.18203/2320-1770.ijrcog20172533.

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Background: O’Driscoll and Meagher (1968) introduced amniotomy as a component of active management of labour. Several institutions have implemented components of this management scheme with varying results. There is a risk of cord prolapse, variability in fetal heart rate, increased chances of ascending infection which may culminate in chorioamnionitis. As per certain studies, fetal outcome is similar in case of Amniotomy and spontaneous ruptured membranes. As source of great controversy, the active management of labor, as classically defined, is routinely misunderstood and misapplied in many clinical settings. Some previous randomized trials suggest Amniotomy as an effective and safe method for induction and augmentation of labour without altering rate of cesarean section while some disagree. Hence, the study was designed to evaluate the effect of amniotomy on perinatal outcome.Methods: As per the selection criteria, 250 women with singleton uncomplicated pregnancy with spontaneous onset of labour admitted in labour ward were enrolled in the study. All cases were randomized and allotted to either study group (ARM group) or control group (SRM group) equally according to random number table generated by computer. Women of study group offered amniotomy at 4cm dilatation of cervix. Before doing Amniotomy, fetal lie and presentation, engagement of head and fetal heart sounds were conformed. The results were then recorded.Results: Planned amniotomy is recommended where the clinician suspects fetal compromise as early detection of MSL in planned amniotomy improves the neonatal outcome. Planned amniotomy does not adversely affect the neonatal outcome in terms of low Apgar score at 5 min, neonatal resuscitation and NICU admission. The incidence of neonates born with MSL in planned amniotomy group is better as compared to neonates born with MSL in SRM group.Conclusions: T Planned amniotomy does not have any adverse effect on the perinatal outcome as compared to SRM group. The incidence of neonates born with MSL in planned amniotomy group is better as compared to neonates born with MSL in SRM group.
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Sharps, Phyllis W., Linda F. Bullock, Jacquelyn C. Campbell, Jeanne L. Alhusen, Sharon R. Ghazarian, Shreya S. Bhandari, and Donna L. Schminkey. "Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial." Journal of Women's Health 25, no. 11 (November 2016): 1129–38. http://dx.doi.org/10.1089/jwh.2015.5547.

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Levett, Kate M., Christine L. Roberts, Judy M. Simpson, and Jonathan M. Morris. "Site-specific predictors of successful recruitment to a perinatal clinical trial." Clinical Trials: Journal of the Society for Clinical Trials 11, no. 5 (July 23, 2014): 584–89. http://dx.doi.org/10.1177/1740774514543539.

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Su, Min, Lynne McLeod, Susan Ross, Andrew Willan, Walter J. Hannah, Eileen Hutton, Sheila Hewson, and Mary E. Hannah. "Factors associated with adverse perinatal outcome in the Term Breech Trial." American Journal of Obstetrics and Gynecology 189, no. 3 (September 2003): 740–45. http://dx.doi.org/10.1067/s0002-9378(03)00822-6.

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25

Papile, L. A. "Magnesium Sulfate in Severe Perinatal Asphyxia: A Randomized Placebo-Controlled Trial." Yearbook of Neonatal and Perinatal Medicine 2009 (January 2009): 184–85. http://dx.doi.org/10.1016/s8756-5005(09)79042-0.

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Barks, J. "Magnesium Sulfate in Severe Perinatal Asphyxia: A Randomized, Placebo-Controlled Trial." Yearbook of Neonatal and Perinatal Medicine 2010 (January 2010): 127–29. http://dx.doi.org/10.1016/s8756-5005(10)79171-x.

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Saitoh, Aya, Akihiko Saitoh, Isamu Sato, Tomohiro Shinozaki, Hajime Kamiya, and Satoko Nagata. "Effect of stepwise perinatal immunization education: A cluster-randomized controlled trial." Vaccine 35, no. 12 (March 2017): 1645–51. http://dx.doi.org/10.1016/j.vaccine.2017.01.069.

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Bhat, Mushtaq Ahmad, Bashir Ahmad Charoo, Javeed Iqbal Bhat, Sheikh Mushtaq Ahmad, Syed Wajid Ali, and Masood-ul-Hassan Mufti. "Magnesium Sulfate in Severe Perinatal Asphyxia: A Randomized, Placebo-Controlled Trial." Obstetrical & Gynecological Survey 64, no. 9 (September 2009): 573–74. http://dx.doi.org/10.1097/01.ogx.0000358028.38402.ff.

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Bhat, M. A., B. A. Charoo, J. I. Bhat, S. M. Ahmad, S. W. Ali, and M. u. H. Mufti. "Magnesium Sulfate in Severe Perinatal Asphyxia: A Randomized, Placebo-Controlled Trial." PEDIATRICS 123, no. 5 (April 6, 2009): e764-e769. http://dx.doi.org/10.1542/peds.2007-3642.

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Goodman, Janice H., Joanna Prager, Richard Goldstein, and Marlene Freeman. "Perinatal Dyadic Psychotherapy for postpartum depression: a randomized controlled pilot trial." Archives of Women's Mental Health 18, no. 3 (December 20, 2014): 493–506. http://dx.doi.org/10.1007/s00737-014-0483-y.

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KC, Ashish, Anna Bergström, Dipak Chaulagain, Olivia Brunell, Uwe Ewald, Abhishek Gurung, Leif Eriksson, et al. "Scaling up quality improvement intervention for perinatal care in Nepal (NePeriQIP); study protocol of a cluster randomised trial." BMJ Global Health 2, no. 3 (September 2017): e000497. http://dx.doi.org/10.1136/bmjgh-2017-000497.

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IntroductionNepal Perinatal Quality Improvement Project (NePeriQIP) intends to scale up a quality improvement (QI) intervention for perinatal care according to WHO/National guidelines in hospitals of Nepal using the existing health system structures. The intervention builds on previous research on the implementation of Helping Babies Breathe-quality improvement cycle in a tertiary healthcare setting in Nepal. The objective of this study is to evaluate the effect of this scaled-up intervention on perinatal health outcomes.Methods/designCluster-randomised controlled trial using a stepped wedged design with 3 months delay between wedges will be conducted in 12 public hospitals with a total annual delivery rate of 60 000. Each wedge will consist of 3 hospitals. Impact will be evaluated on intrapartum-related mortality (primary outcome), overall neonatal mortality and morbidity and health worker’s performance on neonatal care (secondary outcomes). A process evaluation and a cost-effectiveness analysis will be performed to understand the functionality of the intervention and to further guide health system investments will also be performed.DiscussionIn contexts where resources are limited, there is a need to find scalable and sustainable implementation strategies for improved care delivery. The proposed study will add to the scarce evidence base on how to scale up interventions within existing health systems. If successful, the NePeriQIP model can provide a replicable solution in similar settings where support and investment from the health system is poor, and national governments have made a global pledge to reduce perinatal mortality.Trial registration numberISRCTN30829654.
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Roy, Bithi, Susan Arbuckle, Karen Walker, Catherine Morgan, Claire Galea, Nadia Badawi, and Iona Novak. "The Role of the Placenta in Perinatal Stroke: A Systematic Review." Journal of Child Neurology 35, no. 11 (June 9, 2020): 773–83. http://dx.doi.org/10.1177/0883073820929214.

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Context: Placental pathology may be an important missing link in the causal pathway of perinatal stroke. The study aim was to systematically review the literature regarding the role of the placenta in perinatal stroke. MEDLINE, Embase, Scopus, and Web of Science electronic databases were searched from 2000 to 2019. Studies were selected based on predefined criteria. To enable comparisons, placental abnormalities were coded using Redline’s classification. Results: Ten studies met the inclusion criteria. Less than a quarter of stroke cases had placental pathology reported. Placental abnormalities were more common among children with perinatal stroke than in the control group. The most frequent placental abnormality was Redline’s category 2 (thrombo-inflammatory process). Conclusions: Placental abnormalities appear to be associated with perinatal stroke, supporting additional indirect evidence and biological plausibility of a causative role. However, the results should be interpreted cautiously considering the low frequency of placental examination and lack of uniformity in placental pathology reporting. Clinical Trial Registration: PROSPERO Registration no: CRD42017081256.
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Chappell, Lucy C., Jennifer L. Bell, Anne Smith, Catherine Rounding, Ursula Bowler, Louise Linsell, Edmund Juszczak, et al. "Ursodeoxycholic acid to reduce adverse perinatal outcomes for intrahepatic cholestasis of pregnancy: the PITCHES RCT." Efficacy and Mechanism Evaluation 7, no. 9 (December 2020): 1–42. http://dx.doi.org/10.3310/eme07090.

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Background Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and raised serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment, but without an adequate evidence base. Objective We aimed to evaluate whether or not ursodeoxycholic acid reduces adverse perinatal outcomes in affected women. Design Multicentre, masked, randomised, placebo-controlled, two-arm, parallel-group trial. Setting Thirty-three UK maternity units. Participants Women with intrahepatic cholestasis of pregnancy aged ≥ 18 years, between 20+0 and 40+6 weeks’ gestation with a singleton or twin pregnancy and no known lethal fetal anomaly. Interventions Women were randomly assigned (1 : 1 allocation ratio) to take ursodeoxycholic acid tablets or matched placebo tablets, at an equivalent dose of 1000 mg daily, titrated as needed. Main outcome measures The primary outcome was a composite of perinatal death (in utero fetal death after randomisation or known neonatal death up to 7 days) or preterm delivery (< 37 weeks’ gestation) or neonatal unit admission for at least 4 hours (from birth until hospital discharge). Each infant was counted once within this composite. Analyses were by intention to treat. Results Between 23 December 2015 and 7 August 2018, 605 women were randomised, with 305 women allocated to the ursodeoxycholic acid arm and 300 women to the placebo arm. There was no evidence of a significant difference in the incidence of the primary outcome between the groups: 23.0% (74 out of 322 infants) in the ursodeoxycholic acid group compared with 26.7% (85 out of 318 infants) in the placebo group; adjusted risk ratio 0.85 (95% confidence interval 0.62 to 1.15). There was no evidence of a significant difference in total costs (maternal, infant and the cost of ursodeoxycholic acid) between the two trial groups. There were two serious adverse events in the ursodeoxycholic acid group and six in the placebo group. Limitations Limitations include a primary outcome event rate in the control group that was lower than that estimated for the sample size calculation, but the lack of evidence of effect in all analyses suggests that it is unlikely that the trial had insufficient power. Conclusions In this clinical trial of ursodeoxycholic acid in women with intrahepatic cholestasis of pregnancy, there is no evidence that it is effective in reducing a composite of adverse perinatal outcomes. Future work Future research should aim to elucidate the aetiology and pathophysiology of adverse perinatal outcomes, particularly stillbirth, in women with intrahepatic cholestasis of pregnancy to assist the development of an effective preventative treatment. Further exploratory analyses may identify groups of women who might respond to ursodeoxycholic acid treatment. Trial registration Current Controlled Trials ISRCTN91918806. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 9. See the NIHR Journals Library website for further project information.
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Dawson, Samantha L., Jeffrey M. Craig, Gerard Clarke, Mohammadreza Mohebbi, Phillip Dawson, Mimi LK Tang, and Felice N. Jacka. "Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 8, no. 10 (October 21, 2019): e14771. http://dx.doi.org/10.2196/14771.

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Background The early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota. Objective The aim of this study is to assess the efficacy of a perinatal educational dietary intervention in influencing gut microbiota in mothers and infants 4 weeks after birth. Methods The Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, Victoria, Australia. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants’ diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes. Results The study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017. Conclusions Data from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life. Trial Registration Australian Clinical Trials Registration Number ACTRN12616000936426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370939 International Registered Report Identifier (IRRID) DERR1-10.2196/14771
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Kaur, Devindra, and Harminder Singh. "Study of obstetric and perinatal outcome in previous cesarean by sonographic evaluation of scar thickness of lower uterine segment at term." International Journal of Scientific Reports 1, no. 3 (July 29, 2015): 159. http://dx.doi.org/10.18203/issn.2454-2156.intjscirep20150350.

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<p class="abstract"><strong>Background:</strong> Aim of study was to evaluate sonographically the scar thickness in pregnant women with previous one cesarean and study obstetric and perinatal outcome after trial of labour based on scar thickness.</p><p class="abstract"><strong>Methods:</strong> 50 pregnant women of gestational age &gt;37 weeks were included in this prospective study. They were subjected to transabdominal ultrasound to search for thinnest zone of lower segment. Cases with scar thickness &lt;3.5 mm were subjected to elective caesarean LSCS. Cases with scar thickness ≥3.5 were subjected to a trial of labour. Obstetric, perinatal outcome and hospital stay was studied.</p><p class="abstract"><strong>Results:</strong> 32 women had scar thickness ≥3.5 mm (mean = 3.99 ± 0.32). 18 women had scar thickness of &lt;3.5 mm (mean = 3.16 ± 0.29). All patients subjected to elective LSCS showed Grade 2 and Grade 3 thinning of lower segment. This finding was found to be highly significant (p&lt;0.001). Cases who delivered vaginally had hospital stay ranging from 30 hours to 70 hours while those undergoing LSCS stayed 230 to 280 hours. This difference was statistically highly significant (p&lt;0.001). The perinatal outcome was good.</p><strong>Conclusions:</strong> Sonographic evaluation of scar thickness is safe and accurate procedure and is recommended in considering a trial of labour after previous one caesarean.
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Diederen, Carlijn M. J., Frank van Bel, and Floris Groenendaal. "Complications During Therapeutic Hypothermia After Perinatal Asphyxia: A Comparison with Trial Data." Therapeutic Hypothermia and Temperature Management 8, no. 4 (December 2018): 211–15. http://dx.doi.org/10.1089/ther.2017.0046.

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37

Saitoh, Aya, Satoko Nagata, Akihiko Saitoh, Yuki Tsukahara, Florin Vaida, Tomoyoshi Sonobe, Hajime Kamiya, Takashi Naruse, and Sachiyo Murashima. "Perinatal immunization education improves immunization rates and knowledge: A randomized controlled trial." Preventive Medicine 56, no. 6 (June 2013): 398–405. http://dx.doi.org/10.1016/j.ypmed.2013.03.003.

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38

Thornton, Yvonne S., Claudia Smarkola, Sharon M. Kopacz, and Sabriya B. Ishoof. "Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women: A Randomized Clinical Trial." Journal of the National Medical Association 101, no. 6 (June 2009): 569–77. http://dx.doi.org/10.1016/s0027-9684(15)30942-1.

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Lilford, R. "Formal measurement of clinical uncertainty: prelude to a trial in perinatal medicine." BMJ 308, no. 6921 (January 8, 1994): 111–13. http://dx.doi.org/10.1136/bmj.308.6921.111.

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Goldberg, Ronald N., Pedro Moscoso, Charles R. Bauer, Frederick L. Bloom, Richard G. Curless, Barbara Burke, and Eduardo Bancalari. "Use of barbiturate therapy in severe perinatal asphyxia: A randomized controlled trial." Journal of Pediatrics 109, no. 5 (November 1986): 851–56. http://dx.doi.org/10.1016/s0022-3476(86)80713-2.

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Mihelic, Mandy, Alina Morawska, and Ania Filus. "DOES A PERINATAL PARENTING INTERVENTION WORK FOR FATHERS? A RANDOMIZED CONTROLLED TRIAL." Infant Mental Health Journal 39, no. 6 (October 19, 2018): 687–98. http://dx.doi.org/10.1002/imhj.21748.

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Grote, Nancy K., Susan J. Spieker, Mary Jane Lohr, Sharon L. Geibel, Holly A. Swartz, Ellen Frank, Patricia R. Houck, and Wayne Katon. "IMPACT OF CHILDHOOD TRAUMA ON THE OUTCOMES OF A PERINATAL DEPRESSION TRIAL." Depression and Anxiety 29, no. 7 (March 23, 2012): 563–73. http://dx.doi.org/10.1002/da.21929.

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Grote, Nancy K., Wayne J. Katon, Joan E. Russo, Mary Jane Lohr, Mary Curran, Erin Galvin, and Kathy Carson. "COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL." Depression and Anxiety 32, no. 11 (September 8, 2015): 821–34. http://dx.doi.org/10.1002/da.22405.

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Brunell, Olivia, Dipak Chaulagain, Ashish KC, Anna Bergström, and Mats Målqvist. "Effect of a perinatal care quality improvement package on patient satisfaction: a secondary outcome analysis of a cluster-randomised controlled trial." BMJ Open 12, no. 6 (June 2022): e054544. http://dx.doi.org/10.1136/bmjopen-2021-054544.

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ObjectiveTo investigate the effect of a quality improvement (QI) package on patient satisfaction of perinatal care.DesignSecondary analysis of a stepped-wedge cluster-randomised controlled trial. Participating hospitals were randomised by size into four different wedges.Setting12 secondary-level public hospitals in Nepal.ParticipantsWomen who gave birth in the hospitals at a gestational age of ≥22 weeks, with fetal heart sound at admission. Adverse outcomes were excluded. One hospital was excluded due to data incompleteness and four low-volume hospitals due to large heterogeneity. The final analysis included 54 919 women.InterventionHospital management was engaged and facilitators were recruited from within hospitals. Available perinatal care was assessed in each hospital, followed by a bottle-neck analysis workshop. A 3-day training in essential newborn care was carried out for health workers involved in perinatal care, and a set of QI tools were introduced to be used in everyday practice (skill-checks, self-assessment checklists, scoreboards and weekly Plan–Do–Study–Act meetings). Refresher training after 6 months.Outcome measureWomen’s satisfaction with care during childbirth (a prespecified secondary outcome).ResultsThe likelihood of women being overall satisfied with care during childbirth increased after the intervention (adjusted OR (aOR): 1.66, 95% CI: 1.59 to 1.73). However, the proportions of overall satisfaction were low (control 58%, intervention 62%). Women were more likely to be satisfied with education and information from health workers after intervention (aOR: 1.34, 95% CI: 1.29 to 1.40) and to have been treated with dignity and respect (aOR: 1.81, 95% CI: 1.52 to 2.16). The likelihood of having experienced abuse during the hospital stay decreased (aOR: 0.42, 95% CI: 0.34 to 0.51) and of being satisfied with the level of privacy increased (aOR: 1.14, 95% CI: 1.09 to 1.18).ConclusionsImprovements in patient satisfaction were indicated after the introduction of a QI-package on perinatal care. We recommend further studies on which aspects of care are most important to improve women’s satisfaction of perinatal care in hospitals in Nepal.Trial registration numberISRCTN30829654.
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Brunell, Olivia, Dipak Chaulagain, Ashish KC, Anna Bergström, and Mats Målqvist. "Effect of a perinatal care quality improvement package on patient satisfaction: a secondary outcome analysis of a cluster-randomised controlled trial." BMJ Open 12, no. 6 (June 2022): e054544. http://dx.doi.org/10.1136/bmjopen-2021-054544.

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ObjectiveTo investigate the effect of a quality improvement (QI) package on patient satisfaction of perinatal care.DesignSecondary analysis of a stepped-wedge cluster-randomised controlled trial. Participating hospitals were randomised by size into four different wedges.Setting12 secondary-level public hospitals in Nepal.ParticipantsWomen who gave birth in the hospitals at a gestational age of ≥22 weeks, with fetal heart sound at admission. Adverse outcomes were excluded. One hospital was excluded due to data incompleteness and four low-volume hospitals due to large heterogeneity. The final analysis included 54 919 women.InterventionHospital management was engaged and facilitators were recruited from within hospitals. Available perinatal care was assessed in each hospital, followed by a bottle-neck analysis workshop. A 3-day training in essential newborn care was carried out for health workers involved in perinatal care, and a set of QI tools were introduced to be used in everyday practice (skill-checks, self-assessment checklists, scoreboards and weekly Plan–Do–Study–Act meetings). Refresher training after 6 months.Outcome measureWomen’s satisfaction with care during childbirth (a prespecified secondary outcome).ResultsThe likelihood of women being overall satisfied with care during childbirth increased after the intervention (adjusted OR (aOR): 1.66, 95% CI: 1.59 to 1.73). However, the proportions of overall satisfaction were low (control 58%, intervention 62%). Women were more likely to be satisfied with education and information from health workers after intervention (aOR: 1.34, 95% CI: 1.29 to 1.40) and to have been treated with dignity and respect (aOR: 1.81, 95% CI: 1.52 to 2.16). The likelihood of having experienced abuse during the hospital stay decreased (aOR: 0.42, 95% CI: 0.34 to 0.51) and of being satisfied with the level of privacy increased (aOR: 1.14, 95% CI: 1.09 to 1.18).ConclusionsImprovements in patient satisfaction were indicated after the introduction of a QI-package on perinatal care. We recommend further studies on which aspects of care are most important to improve women’s satisfaction of perinatal care in hospitals in Nepal.Trial registration numberISRCTN30829654.
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Shah, Jaimin, Tania Roman, Oscar Viteri, Ziad Haidar, Alejandra Ontiveros, and Baha Sibai. "The Relationship of Assisted Reproductive Technology on Perinatal Outcomes in Triplet Gestations." American Journal of Perinatology 35, no. 14 (June 8, 2018): 1388–93. http://dx.doi.org/10.1055/s-0038-1660457.

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Objective To assess whether assisted reproductive technology (ART) is associated with increased risk of adverse perinatal outcomes in triplet gestations compared with spontaneous conception. Study Design Secondary analysis of a multicenter randomized trial for the prevention of preterm birth in multiple gestations. Triplets delivered at ≥ 24 weeks were studied. The primary outcome was the rate of composite neonatal morbidity (CNM) that included one or more of the following: bronchopulmonary dysplasia, respiratory distress syndrome, necrotizing enterocolitis, culture proven sepsis, pneumonia, retinopathy of prematurity, intraventricular hemorrhage, periventricular leukomalacia, or perinatal death. Results There were 381 triplets (127 women) of which 89 patients conceived via ART and 38 patients spontaneously. Women with ART were more likely to be older, Caucasian, married, nulliparous, have higher level of education, and develop pre-eclampsia. Spontaneously conceived triplets were more likely to delivery at an earlier gestation (31.2 ± 3.5 vs 32.8 ± 2.7 weeks) (p = 0.009) with a lower birth weight (p < 0.001). After adjusting for confounders, no differences were noted in culture proven sepsis, perinatal death, CNM, respiratory distress syndrome, or Apgar score < 7 at 5 minutes. All remaining perinatal outcomes were similar. Conclusion Triplets conceived by ART had similar perinatal outcomes compared with spontaneously conceived triplets.
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Mei, Jenny Y., Alexandra L. Havard, Amanda J. Mularz, Melanie M. Maykin, and Stephanie L. Gaw. "Impact of Gestational Weight Gain on Trial of Labor after Cesarean Success." American Journal of Perinatology 36, no. 10 (November 30, 2018): 1023–30. http://dx.doi.org/10.1055/s-0038-1675624.

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Objective Excessive gestational weight gain (GWG) has been associated with adverse pregnancy outcomes, including increased risk of cesarean delivery (CD). Data are limited on associations between GWG and outcomes in women undergoing trial of labor after cesarean (TOLAC). We aimed to investigate whether appropriate GWG impacts TOLAC outcomes. Study Design We performed a retrospective cohort study of women undergoing TOLAC at a single institution from May 2007 to April 2016. Women were divided into three groups based on GWG as compared with the Institute of Medicine recommendations. The primary outcome was successful vaginal birth after cesarean (VBAC). Secondary outcomes included various perinatal morbidity markers. Results A total of 614 women underwent TOLAC, of whom 444 (72.3%) had successful VBACs. When grouped by GWG in accordance with the Institute of Medicine guidelines, 149 (24.3%) women had GWG below guidelines, 224 (36.5%) met guidelines, and 241(39.3%) exceeded guidelines. There was no difference in the rate of VBAC success among the three groups. We also found no differences in secondary perinatal morbidity markers. Conclusion We found no difference in TOLAC success rates with excess GWG. Providers should not consider excess GWG a risk factor for failed TOLAC, even in obese patients.
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Kanoute, Aida, Jocelyne Gare, Nicolas Meda, Stephane Viennot, Paul Tramini, Laurie Fraticelli, Florence Carrouel, and Denis Bourgeois. "Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial." Methods and Protocols 4, no. 3 (September 5, 2021): 61. http://dx.doi.org/10.3390/mps4030061.

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Pre-eclampsia (PE), a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction, remains a major source of maternal and perinatal morbidity and mortality, especially in low- and middle-income settings. Periodontal disorders during pregnancy, and particularly periodontal pathogens, may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk and modulate the dysbiosis of the oral microbiome. The aim of this trial is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. This trial is designed as a two-arm, parallel, cluster randomized controlled trial with the antenatal obstetric clinic as the unit of randomization and an allocation ratio of 1:1. The pregnant women will be included at 3 months of pregnancy and will be followed throughout the pregnancy. The primary outcome measure will be the incidence of PE from a baseline during the pregnancy. Secondary outcomes measures will include changes from the baseline in quantification of the pathogenic bacterial load of the interdental microbiota, the severity scores of periodontal indicators, and the incidence of adverse perinatal outcomes. This trial should demonstrate that the implementation of daily oral hygiene reduces oral dysbiosis, the incidence of periodontal disease, and the risk of PE.
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Basnet, Tulasa, Baburam Dixit Thapa, Dipti Das, Ramesh Shrestha, Sarita Sitaula, and Anu Thapa. "Maternal and Perinatal Outcomes of Singleton Term Breech Vaginal Delivery at a Tertiary Care Center in Nepal: A Retrospective Analysis." Obstetrics and Gynecology International 2020 (November 16, 2020): 1–8. http://dx.doi.org/10.1155/2020/4039140.

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Background. Breech presentation is associated with increased rates of maternal and perinatal morbidity regardless of mode of delivery. After the results of Term Breech Trial, most of the countries adopted the protocol of cesarean section for term breech delivery because of which breech vaginal delivery is becoming rare. The aim of this study is to evaluate short-term maternal and perinatal outcomes of breech vaginal delivery at a tertiary care hospital in Nepal. Methods. A retrospective review of case records of all women who had vaginal breech delivery from April 13, 2016, to April 12, 2018, was conducted, over a period of two years. Available demographic variables, obstetric characteristics, details of labor, postpartum complications, and perinatal complications were recorded and analyzed. Results. Out of 21,768 cases of deliveries during the study period, the incidence of term breech deliveries was 528 (2.4%) among which the mode of only 84 (17.8%) deliveries was vaginal. Most of the deliveries were unplanned and were conducted because emergency cesarean section could not be performed. Three (3.6%) women had postpartum hemorrhage, and four (4.8%) had entrapment of aftercoming head, two of them requiring Dührssen incisions. Adverse perinatal outcomes were seen in 23.8% of such deliveries with <7 APGAR score at 5 minutes in 20.2%, neonatal admission in 17.7%, and perinatal mortality in 8.3%. The perinatal mortality was significantly associated with birthweight less than 2500 grams as compared to birthweight ≥2500 grams (21.1% versus 4.6%; P = 0.043 ). Conclusion. The perinatal outcomes for vaginal breech delivery are grave with our existing health facilities, especially when the deliveries are not well planned.
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50

Schrag, Stephanie J., Clare L. Cutland, Elizabeth R. Zell, Locadiah Kuwanda, Eckhart J. Buchmann, Sithembiso C. Velaphi, Michelle J. Groome, and Shabir A. Madhi. "Risk Factors for Neonatal Sepsis and Perinatal Death Among Infants Enrolled in the Prevention of Perinatal Sepsis Trial, Soweto, South Africa." Pediatric Infectious Disease Journal 31, no. 8 (August 2012): 821–26. http://dx.doi.org/10.1097/inf.0b013e31825c4b5a.

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