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Group prenatal care and perinatal outcomes: a randomized controlled trial.

ABSTRACT: To determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences.A multisite randomized controlled trial was conducted at two university-affiliated hospital prenatal clinics. Pregnant women aged 14-25 years (n=1,047) were randomly assigned to either standard or group care. Women with medical conditions requiring individualized care were excluded from randomization. Group participants received care in a group setting with women having the same expected delivery month. Timing and content of visits followed obstetric guidelines from week 18 through delivery. Each 2-hour prenatal care session included physical assessment, education and skills building, and support through facilitated group discussion. Structured interviews were conducted at study entry, during the third trimester, and postpartum.Mean age of participants was 20.4 years; 80% were African American. Using intent-to-treat analyses, women assigned to group care were significantly less likely to have preterm births compared with those in standard care: 9.8% compared with 13.8%, with no differences in age, parity, education, or income between study conditions. This is equivalent to a risk reduction of 33% (odds ratio 0.67, 95% confidence interval 0.44-0.99, P=.045), or 40 per 1,000 births. Effects were strengthened for African-American women: 10.0% compared with 15.8% (odds ratio 0.59, 95% confidence interval 0.38-0.92, P=.02). Women in group sessions were less likely to have suboptimal prenatal care (P<.01), had significantly better prenatal knowledge (P<.001), felt more ready for labor and delivery (P<.001), and had greater satisfaction with care (P<.001). Breastfeeding initiation was higher in group care: 66.5% compared with 54.6%, P<.001. There were no differences in birth weight nor in costs associated with prenatal care or delivery.Group prenatal care resulted in equal or improved perinatal outcomes at no added cost.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271960I.

SUBMITTER: Ickovics JR

PROVIDER: S-EPMC2276878 | biostudies-literature | 2007 Aug

REPOSITORIES: biostudies-literature

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Group prenatal care and perinatal outcomes: a randomized controlled trial.

Ickovics Jeannette R JR Kershaw Trace S TS Westdahl Claire C Magriples Urania U Massey Zohar Z Reynolds Heather H Rising Sharon Schindler SS

Obstetrics and gynecology 20070801 2 Pt 1

<h4>Objective</h4>To determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences.<h4>Methods</h4>A multisite randomized controlled trial was conducted at two university-affiliated hospital prenatal clinics. Pregnant women aged 14-25 years (n=1,047) were randomly assigned to either standard or group care. Women with medical conditions requiring individualized care were excluded from randomization. Gro ...[more]

PMID: 17666608

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Project description:ObjectiveThis study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities.Study designA pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle.ResultsOf 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms.ConclusionDiabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes.Key points· Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..

Project description:IntroductionImproving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health.Methods and findingsA cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60-1.22), and the neonatal mortality rate higher (1.48, 1.06-2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90-1.57). We have no evidence that these differences could be explained by the intervention.ConclusionsFacilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.Trial registrationCurrent Controlled Trials ISRCTN96256793

Project description:BackgroundDespite biomedical advances and intervention efforts, rates of preterm birth and other adverse outcomes in the United States have remained relatively intransigent. Evidence suggests that group prenatal care can reduce these risks, with implications for maternal and child health as well as substantial cost savings. However, widespread dissemination presents challenges, in part because training and health systems have not been designed to deliver care in a group setting. This manuscript describes the design and evaluation of Expect With Me, an innovative model of group prenatal care with a strong integrated information technology (IT) platform designed to be scalable nationally.Methods/designExpect With Me follows clinical guidelines from the American Congress of Obstetricians and Gynecologists. Expect With Me incorporates the best evidence-based features of existing models of group care with a novel integrated IT platform designed to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. A multisite prospective longitudinal cohort study is being conducted to examine the impact of Expect With Me on perinatal and postpartum outcomes, and to identify and address barriers to national scalability. Process and outcome evaluation will include quantitative and qualitative data collection at patient, provider, and organizational levels. Mixed-method data collection includes patient surveys, medical record reviews, patient focus groups; provider surveys, session evaluations, provider focus groups and in-depth interviews; an online tracking system; and clinical site visits. A two-to-one matched cohort of women receiving individual care from each site will provide a comparison group (n = 1,000 Expect With Me patients; n = 2,000 individual care patients) for outcome and cost analyses.DiscussionBy bundling prevention and care services into a high-touch, high-tech group prenatal care model, Expect With Me has the potential to result in fundamental changes to the health care system to meet the "triple aim:" better healthcare quality, improved outcomes, and lower costs. Findings from this study will be used to optimize the dissemination and effectiveness of this model.Trial registrationClinicalTrials.gov, NCT02169024 . Retrospectively registered on June 18, 2014.

Project description:ObjectiveTo evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan.MethodsIn this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition.ResultsFrom June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53-1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49-1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups.ConclusionsThe IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity.Clinical trial registrationClinicalTrials.gov, NCT02309138.

Project description:BackgroundFetal growth restriction (FGR) affects 7-10% of all pregnancies resulting in a higher risk of perinatal morbidity and mortality, long-term disabilities, and cognitive impairment. Due to its multifactorial etiology, changes in maternal lifestyle, including suboptimal maternal diet and stress, have increasingly been associated with its prevalence. We present a protocol for the Improving Mothers for a better PrenAtal Care Trial Barcelona (IMPACT BCN), which evaluates two different maternal lifestyle strategies (improved nutrition by promoting Mediterranean diet and stress reduction program based on mindfulness techniques) on perinatal outcomes. The primary objective is to reduce the prevalence of FGR. Secondary aims are to reduce adverse perinatal outcomes and to improve neurodevelopment and cardiovascular profile in children at 2 years of age.MethodsA randomized parallel, open-blind, single-center trial following a 1:1:1 ratio will select and randomize high-risk singleton pregnancies for FGR (N=1218), according to the criteria of the Royal College of Obstetricians and Gynaecologists (19.0-23.6 weeks' gestation), into three arms: Mediterranean diet, mindfulness-based stress reduction program, and usual care without any intervention. Compliance to the interventions will be randomly tested in 30% of participants with specific biomarkers. Maternal socio-demographic, clinical data, biological samples, and lifestyle questionnaires will be collected at enrollment and at the end of the interventions (34.0-36.6 weeks' gestation), together with a fetoplacental ultrasound and magnetic resonance. Fetoplacental biological samples and perinatal outcomes will be recorded at delivery. Postnatal follow-up is planned up to 2 years of corrected age including neurodevelopmental tests and cardiovascular assessment. Intention-to-treat and population per-protocol analysis will be performed.DiscussionThis is the first randomized study evaluating the impact of maternal lifestyle interventions during pregnancy on perinatal outcomes. The maternal lifestyle interventions (Mediterranean diet and mindfulness-based stress reduction program) are supported by scientific evidence, and their compliance will be evaluated with several biomarkers.Trial registrationClinicalTrials.gov NCT03166332 . Registered on April 19, 2017.

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Group prenatal care and perinatal outcomes: a randomized controlled trial.

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Group prenatal care and perinatal outcomes: a randomized controlled trial.

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