A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation (PIINC)

NorthShore University HealthSystem

Status: Completed

Conditions: Preterm Birth

Treatments: Behavioral: CenteringPregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT04097548

EH17-256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,133 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,133 participants in 2 patient groups

CenteringPregnancy group prenatal care

Experimental group

Description:

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

Treatment:

Behavioral: CenteringPregnancy

Traditional individual prenatal care

No Intervention group

Description:

Pregnant women who were randomized to receive traditional individual prenatal care.