Motherhood and Microbiome

NCT02030106 | Completed

• 2 other identifiers: 818914R01NR014784-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cervicovaginal Microbiota in Women With and Without Preterm Birth

  Cervicovaginal Microbiota in Women With and Without Preterm Birth

  Enrollment through delivery

Secondary Outcomes (1)

• Potential Modifiers of the Cervicovaginal Microbiome

  Enrollment through delivery

Study Arms (2)

Prior Preterm Birth Patients

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

Term Birth Patients

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

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 20 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Women will self-collect samples of their cervicovaginal fluid using large cotton swabs. Subjects who have had a previous preterm birth will also have cervical cells collected in the same manner that cells are collected for a routine pap smear.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michal A Elovitz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 8, 2014
• Study Start: October 1, 2013
• Primary Completion: February 3, 2017
• Study Completion: June 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

US (1)