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

November 7, 2023 updated by: Ann Borders, NorthShore University HealthSystem

Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CenteringPregnancy group prenatal care
Pregnant women who were randomized to receive CenteringPregnancy group prenatal care.
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.
No Intervention: Traditional individual prenatal care
Pregnant women who were randomized to receive traditional individual prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of placental chronic inflammatory lesions, characterized histologically
Time Frame: Measured at delivery
Measured at delivery
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
Time Frame: Measured at delivery
Measured at delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
Time Frame: 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
Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Time Frame: Up to 43 weeks gestation
Characterization of transcription control differences by exposure in maternal blood via TELiS promoter sequence analysis. Pathways involved in fetal tolerance, inflammatory activity, and organ development will be characterized. 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. The number of differentially expressed transcripts will be totaled. Differential expression will be determined by greater than or equal to a 1.25-fold differential expression between exposure groups.
Up to 43 weeks gestation
Differential expression of mRNA gene transcripts for 34,000 human genes
Time Frame: 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.
Measured at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ann Border, MD, MSc, NorthShore University HealthSystem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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