Motherhood and Microbiome (M&M)

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth

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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 3, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Microbiome; Microbiota; Preterm Birth; Cervicovaginal microbiome; Cervical Remodeling; Preterm delivery
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 818914; R01NR014784-01 (U.S. NIH Grant/Contract)