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Completed

NCT Number: NCT04097548

A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Health System

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

CenteringPregnancy

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.

Primary outcomes

  1. Prevalence of placental chronic inflammatory lesions, characterized histologically

    Time frame: Measured at delivery

  2. Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes

    Time frame: Measured at delivery

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Northwestern University
  • Prisma Health-Upstate
  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: PIINC

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Sep 20, 2019
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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