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Motherhood and Microbiome — M&M  

Preterm Birth Clinical Trial

Official title:
Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02030106
Study type Observational
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date June 1, 2017
View Details
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