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

Primary Purpose

Preterm Birth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CenteringPregnancy
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Pregnancy

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Greenville Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CenteringPregnancy group prenatal care

Traditional individual prenatal care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
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
Differential expression of mRNA gene transcripts for 34,000 human genes
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.
Differential expression of mRNA gene transcripts for 34,000 human genes
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.

Full Information

First Posted
June 26, 2019
Last Updated
January 31, 2023
Sponsor
NorthShore University HealthSystem
Collaborators
Prisma Health-Upstate, Northwestern University, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04097548
Brief Title
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
Acronym
PIINC
Official Title
Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Prisma Health-Upstate, Northwestern University, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CenteringPregnancy group prenatal care
Arm Type
Experimental
Arm Description
Pregnant women who were randomized to receive CenteringPregnancy group prenatal care.
Arm Title
Traditional individual prenatal care
Arm Type
No Intervention
Arm Description
Pregnant women who were randomized to receive traditional individual prenatal care.
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of placental chronic inflammatory lesions, characterized histologically
Time Frame
Measured at delivery
Title
Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
Time Frame
Measured at delivery
Secondary Outcome Measure Information:
Title
Concentration (pg/mL) of inflammatory cytokines in peripheral maternal blood via multiplex immunoassays
Description
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
Time Frame
Up to 43 weeks gestation
Title
Differential expression of mRNA gene transcripts for 34,000 human genes
Description
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.
Time Frame
Up to 43 weeks gestation
Title
Differential expression of mRNA gene transcripts for 34,000 human genes
Description
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.
Time Frame
Measured at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Border, MD, MSc
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

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