Placental Inflammation in Prenatal Care

NCT ID: NCT02476656

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

Detailed Description

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This study aims to evaluate levels of inflammatory markers and genetic indicators of stress an inflammation in the placentas and umbilical cord blood in pregnancies that undergo group prenatal care as compared to traditional prenatal care. The investigators know that women receiving group prenatal care have fewer spontaneous preterm deliveries. What is not known is the mechanism behind this difference. By collecting umbilical cord blood samples and placentas of 40 women at the time of delivery, the investigators hope to study expression of stress-related genes and levels of inflammatory markers at the maternal-fetal interface.

Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GPNC

CenteringPregnancy group prenatal care

No interventions assigned to this group

IPNC

Individual prenatal care

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years
* Singleton pregnancy

Exclusion Criteria

* Presence of known fetal congenital anomalies (lethal anomaly or anomalies that may lead to early delivery or increased risk of neonatal death).
* Presence of known chromosomal abnormalities
* Progesterone treatment during the current pregnancy after 14 weeks
* Chronic corticosteroid (i.e. Prednisone or other steroids) treatment during the current pregnancy (not including inhalers or topical)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Picklesimer, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Other Identifiers

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Pro#00037264

Identifier Type: -

Identifier Source: org_study_id

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