Motherhood and Microbiome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02030106

Acronym

M&M

Enrollment

2000

Registered

2014-01-08

Start date

2013-10-31

Completion date

2017-06-01

Last updated

2017-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Cervicovaginal microbiome, Microbiome, Preterm Birth, Cervical Remodeling, Preterm delivery, Microbiota

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 50 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Cervicovaginal Microbiota in Women With and Without Preterm Birth	Enrollment through delivery	Cervicovaginal Microbiota in Women With and Without Preterm Birth

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results