Trials / Completed
CompletedNCT04097548
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,133 (actual)
- Sponsor
- Endeavor Health · Academic / Other
- Sex
- Female
- Age
- 14 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the PIINC study is to identify differences in placental inflammatory lesions between women participating in group prenatal care versus standard prenatal care, and additionally, examine whether the frequency of placental inflammatory lesions differ by race and income. The investigators hypothesize that women participating in group prenatal care will have lower pro-inflammatory profiles compared to women in routine prenatal care.
Detailed description
This is a supplementary investigation of placental inflammatory lesions among participants enrolled in a randomized controlled trial comparing biomedical, behavioral and psychosocial outcomes 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 study 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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CenteringPregnancy | 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. |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2020-10-31
- Completion
- 2023-03-31
- First posted
- 2019-09-20
- Last updated
- 2023-11-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04097548. Inclusion in this directory is not an endorsement.