Status:
COMPLETED
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
Prisma Health-Upstate
Northwestern University
Conditions:
Preterm Birth
Eligibility:
FEMALE
14-45 years
Phase:
NA
Brief 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 ...
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 pr...
Eligibility Criteria
Inclusion
- Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
- Pregnant women aged between 14-45 years
- Enrolled in prenatal care by 20 6/7 weeks' gestation
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
1133 Patients enrolled
Trial Details
Trial ID
NCT04097548
Start Date
August 8 2018
End Date
March 31 2023
Last Update
November 9 2023
Active Locations (1)
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1
Greenville Health System
Greenville, South Carolina, United States, 29605