A RCT of CenteringPregnancy on Birth Outcomes
Completed · Not applicable
Conditions studied: Pregnancy, Preterm Birth
In brief
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.
Key facts
- Study ID
- NCT02640638
- Run by
- Clemson University
- People needed
- 2350
- Starts
- 2016-02-24
- Expected to finish
- 2021-01-21
- Last updated by the study team
- 2022-08-26
Who can join
Age: 14 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UCLA — Los Angeles, California, United States
- Georgia State University — Atlanta, Georgia, United States
- Clemson University — Clemson, South Carolina, United States
- Prisma Health — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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