Placental Inflammation in Prenatal Care

Completed

• Conditions: Preterm Birth

• Registration Number: NCT02476656
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-19
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Primary Completion: 2016-01
• Status Verified: 2016-10
• Study Completion: 2017-12
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Age >= 18 years
• Singleton pregnancy

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory markers (CRP, IL-6) of cord blood	drawn from the umbilical cord within 15 minutes of delivery	Circulating concentrations of C-reactive protein and interleukin-6 will be quantified in serum harvested from umblical blood

Secondary Outcome Measures

Name	Time	Method
Genome wide expression profiling of cord blood	drawn from the umbilical cord within 15 minutes of delivery	Mononuclear cells will be isolated from umbilical blood using density gradient centrifugation. RNA will be extracted using Qiagen RNeasy Mini Kits, and quality/quantity checks performed using an Agilent NanoDrop BioAnalyzer.