A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Behavioral: CenteringPregnancy

• Registration Number: NCT04097548
• Lead Sponsor: NorthShore University HealthSystem

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 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.

Study Timeline

• Study Start: 2018-08-08
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Primary Completion: 2020-10-31
• Study Completion: 2023-03-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1133

Inclusion Criteria

1. Enrollment in NICHD 1R01HD082311: Centering and Racial Disparities: A Randomized Controlled Trial on CenteringPregnancy (the "CRaDle" trial).
2. Pregnant women aged between 14-45 years
3. Enrolled in prenatal care by 20 6/7 weeks' gestation

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CenteringPregnancy group prenatal care	CenteringPregnancy	Pregnant women who were randomized to receive CenteringPregnancy group prenatal care.

Primary Outcome Measures

Name	Time	Method
Prevalence of placental chronic inflammatory lesions, characterized histologically	Measured at delivery
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes	Measured at delivery

Secondary Outcome Measures

Name	Time	Method
Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays	Up to 43 weeks gestation	Circulating inflammatory biomarkers C-reactive protein, IL-6, IL-8, IL-10, IL-13, INF-α, and TNF-α (pg/mL) in maternal serum will be measured during the second trimester between 20 weeks 0 days and 25 weeks and 6 days gestation, and during the third trimester between 32 weeks 0 days and 43 weeks 0 days
Differential expression of mRNA gene transcripts for 34,000 human genes	Measured at delivery	Characterization of transcription control differences by exposure in fresh placental biopsies via TELiS promoter sequence analysis. Pathways involved in fetal tolerance, inflammatory activity, and organ development will be characterized. The number of differentially expressed genes will be totaled. Differential expression will be determined by greater than or equal to a 1.25-fold differential expression between exposure groups.

Trial Locations

Locations (1)

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States