Motherhood and Microbiome

Completed

• Conditions: Preterm Birth

• Registration Number: NCT02030106
• Lead Sponsor: University of Pennsylvania

Brief Summary

This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.

Detailed Description

Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2017-02-03
• Study Completion: 2017-06-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Pregnant women receiving care in University of Pennsylvania Health System

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Exclusion Criteria

• Non-singleton pregnancy (twins, triplets, etc.)
• Known major fetal anomaly
• Known HIV positive status
• History of organ transplant
• Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervicovaginal Microbiota in Women With and Without Preterm Birth	Enrollment through delivery	Cervicovaginal Microbiota in Women With and Without Preterm Birth

Secondary Outcome Measures

Name	Time	Method
Potential Modifiers of the Cervicovaginal Microbiome	Enrollment through delivery	Potential modifiers of the cervicovaginal microbiome: behavioral factors, stress, nutrition/obesity, vaginal infections, genetic or host immune differences, race and ethnicity, social behaviors, environmental influences

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States