A RCT of CenteringPregnancy on Birth Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual prenatal care.

Detailed Description
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This is a randomized controlled trial to compare biomedical, behavioral and psychosocial outcomes by race among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The trial will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.

Official Title
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Reducing Disparities in Birth Outcomes: a Randomized Controlled Trial of CenteringPregnancy

Conditions
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Pregnancy, Preterm Birth

Intervention / Treatment
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* Behavioral: CenteringPregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women aged between 14-45 years Entry prenatal care before 20 6/7 weeks gestational age (defined as attendance at the intake screening visit). Patients must be randomized by 23 6/7 weeks gestational age. Exclusion Criteria: Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care Pregestational diabetes, Severe chronic hypertension requiring medication, Morbid Obesity with BMI >49.99 Renal disease with baseline proteinuria >1g/24 hours Any disease requiring chronic immunosuppression (SLE, solid organ transplant) Active pulmonary tuberculosis Sickle cell anemia Human Immunodeficiency Virus Infection Other medical conditions that would exclude women from group care at the discretion of the PI Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care Multiple gestation Lethal fetal anomalies Other pregnancy complications that would exclude women from group care at the discretion of the PI Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care Current incarceration Severe psychiatric illness

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CenteringPregnancy group prenatal care<br>Pregnant women who were randomized to receive CenteringPregnancy group prenatal care | Behavioral: CenteringPregnancy<br>* 8-12 pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.<br>|
| No Intervention: Traditional individual prenatal care<br>Pregnant women who were randomized to receive traditional individual prenatal care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Delivery before 37 weeks gestation | Measured at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight | Infant weight (in grams) a birth | Measured at delivery | 
| APGAR score | Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration | Measured at delivery | 
| Gestational weight gain | Weight gained during pregnancy as compared to medical recommendation | Measured at delivery | 
| Gestational diabetes incidence | Diabetes (occurred during pregnancy (two steps: 50-g GLT (nonfasting) with PG measurement at 1 h (Step 1), at 24-28 wks in women not previously diagnosed with overt diabetes If PG at 1 h after load is ≥140 mg/dL (7.8 mmol/L), proceed to 100-g OGTT (Step 2), performed while patient is fasting GDM diagnosis made when two or more PG levels meet or exceed: Fasting: 95 mg/dL or 105 mg/dL (5.3/5.8) hr: 180 mg/dL or 190 mg/dL (10.0/10.6) hr: 155 mg/dL or 165 mg/dL (8.6/9.2) hr: 140 mg/dL or 145 mg/dL (7.8/8.0) | Measured during pregnancy | 
| Gestational hypertension | Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart | Measured during pregnancy | 
| Patient activation measure | Based on self-reported questionnaire | Measured at <20 week and 32-36 week of gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Racial disparities