Motherhood and Microbiome (M&M)

University of Pennsylvania

Status: Completed

Conditions: Preterm Birth

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02030106

818914

R01NR014784-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 patients

Sex: Female

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

2,000 participants in 2 patient groups

Prior Preterm Birth Patients

Description:

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

Term Birth Patients

Description:

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