Motherhood and Microbiome

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-06-01

Brief Summary

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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.

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Detailed Description

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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.

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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Prior Preterm Birth Patients

All obstetrical patients eligible for the study that have had a prior preterm birth.

No interventions assigned to this group

Term Birth Patients

All obstetrical patients eligible for the study that have not had a prior preterm birth.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Pregnant women receiving care in University of Pennsylvania Health System

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)

Minimum Eligible Age

13 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No