Motherhood and Microbiome

Preterm Birth Clinical Trial

— M&M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030106
• Other study ID #: 818914
• Secondary ID: R01NR014784-01
• Status: Completed
• Phase: N/A
• First received: January 2, 2014
• Last updated: September 8, 2017
• Start date: October 2013
• Est. completion date: June 1, 2017

Study information

• Verified date: September 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 1, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervicovaginal Microbiota in Women With and Without Preterm Birth	Cervicovaginal Microbiota in Women With and Without Preterm Birth	Enrollment through delivery
Secondary	Potential Modifiers of the Cervicovaginal Microbiome	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	Enrollment through delivery