A RCT of CenteringPregnancy on Birth Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-24

Study Completion Date

2021-01-21

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.

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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.

Conditions

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Pregnancy Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CenteringPregnancy group prenatal care

Pregnant women who were randomized to receive CenteringPregnancy group prenatal care

Group Type EXPERIMENTAL

CenteringPregnancy

Intervention Type BEHAVIORAL

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.

Traditional individual prenatal care

Pregnant women who were randomized to receive traditional individual prenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CenteringPregnancy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No