A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

NCT04097548 | Completed

• 1 other identifier: EH17-256
• Study Type: interventional
• Target: 1,133
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays

  Up to 43 weeks gestation

• Differential expression of mRNA gene transcripts for 34,000 human genes

  Up to 43 weeks gestation

• Differential expression of mRNA gene transcripts for 34,000 human genes

  Measured at delivery

Study Arms (2)

CenteringPregnancy group prenatal care

EXPERIMENTAL

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

Behavioral: CenteringPregnancy

Traditional individual prenatal care

NO INTERVENTION

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

Interventions

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.

CenteringPregnancy group prenatal care

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• Prisma Health-Upstate: collaborator
• Northwestern University: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ann Border, MD, MSc

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: September 20, 2019
• Study Start: August 8, 2018
• Primary Completion: October 31, 2020
• Study Completion: March 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)