A RCT of CenteringPregnancy on Birth Outcomes



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:14 - 45
Updated:2/2/2019
Start Date:February 24, 2016
End Date:May 2020
Contact:Liwei Chen, MD, PhD
Email:liweic@clemson.edu
Phone:8646566694

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

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.

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.

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
We found this trial at
1
site
Greenville, South Carolina 29615
Principal Investigator: Amy Picklesimer, MD
Phone: 864-455-5032
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mi
from
Greenville, SC
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