A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

NCT ID: NCT04097548

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2023-03-31

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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CenteringPregnancy group prenatal care

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

Group Type: EXPERIMENTAL

CenteringPregnancy

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Ann Borders

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Border, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Greenville Health System

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

EH17-256

Identifier Type: -

Identifier Source: org_study_id