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

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ClinicalTrials.gov Identifier: NCT04097548
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Prisma Health-Upstate
Northwestern University
University of California, Los Angeles
Information provided by (Responsible Party):
Ann Borders, NorthShore University HealthSystem

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Behavioral: CenteringPregnancy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: CenteringPregnancy group prenatal care
Pregnant women who were randomized to receive CenteringPregnancy group prenatal care.
Behavioral: 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.

No Intervention: Traditional individual prenatal care
Pregnant women who were randomized to receive traditional individual prenatal care.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097548


Contacts
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Contact: Ann Borders, MD, MSc 847-570-1971 borders.ann@gmail.com
Contact: Amy Crockett, MD 864-455-5032 acrockett@ghs.org

Locations
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United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Amy Crockett, MD    864-455-5032    acrockett@ghs.org   
Principal Investigator: Amy Crockett, MD         
Sponsors and Collaborators
NorthShore University HealthSystem
Prisma Health-Upstate
Northwestern University
University of California, Los Angeles
Investigators
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Principal Investigator: Ann Border, MD, MSc NorthShore University HealthSystem

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Responsible Party: Ann Borders, Principal Investigator, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04097548     History of Changes
Other Study ID Numbers: EH17-256
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ann Borders, NorthShore University HealthSystem:
Pregnancy
Additional relevant MeSH terms:
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Premature Birth
Inflammation
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications