Overview

This trial is active, not recruiting.

Condition preterm birth
Sponsor Greenville Health System
Start date June 2015
End date January 2016
Trial size 40 participants
Trial identifier NCT02476656, Pro#00037264

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
CenteringPregnancy group prenatal care
Individual prenatal care

Primary Outcomes

Measure
Inflammatory markers (CRP, IL-6) of cord blood
time frame: drawn from the umbilical cord within 15 minutes of delivery

Secondary Outcomes

Measure
Genome wide expression profiling of cord blood
time frame: drawn from the umbilical cord within 15 minutes of delivery

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Placental Inflammation in Prenatal Care
Principal investigator Amy Picklesimer, MD, MSPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Greenville Health System.