- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097548
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation (PIINC)
Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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.
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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.
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No Intervention: Traditional individual prenatal care
Pregnant women who were randomized to receive traditional individual prenatal care.
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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
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Measured at delivery
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Prevalence of placental chronic inflammatory lesions stratified by placental compartment - decidua vs. villous layer vs. membranes
Time Frame: Measured at delivery
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Measured at delivery
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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
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Up to 43 weeks gestation
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Differential expression of mRNA gene transcripts for 34,000 human genes
Time Frame: Up to 43 weeks gestation
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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.
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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
Investigators
- Principal Investigator: Ann Border, MD, MSc, NorthShore University HealthSystem
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH17-256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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