A RCT of CenteringPregnancy on Birth Outcomes

Not Applicable

Completed

• Conditions: Pregnancy; Preterm Birth
• Interventions: Behavioral: CenteringPregnancy

• Registration Number: NCT02640638
• Lead Sponsor: Clemson University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-02-24
• Primary Completion: 2020-10-14
• Study Completion: 2021-01-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2350

Inclusion Criteria

1. Pregnant women aged between 14-45 years
2. 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

1. 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

2. 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

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CenteringPregnancy group prenatal care	CenteringPregnancy	Pregnant women who were randomized to receive CenteringPregnancy group prenatal care

Primary Outcome Measures

Name	Time	Method
Preterm birth	Measured at delivery	Delivery before 37 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Patient activation measure	Measured at <20 week and 32-36 week of gestational age	Based on self-reported questionnaire
Gestational weight gain	Measured at delivery	Weight gained during pregnancy as compared to medical recommendation
Birth weight	Measured at delivery	Infant weight (in grams) a birth
APGAR score	Measured at delivery	Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
Gestational hypertension	Measured during pregnancy	Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
Gestational diabetes incidence	Measured during pregnancy	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); 1. hr: 180 mg/dL or 190 mg/dL (10.0/10.6); 2. hr: 155 mg/dL or 165 mg/dL (8.6/9.2); 3. hr: 140 mg/dL or 145 mg/dL (7.8/8.0)

Trial Locations

Locations (4)

Georgia State University; 🇺🇸 Atlanta, Georgia, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Clemson University; 🇺🇸 Clemson, South Carolina, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States