Motherhood and Microbiome (M&M)

• ClinicalTrials.gov Identifier: NCT02030106
• Recruitment Status: Completed
• First Posted: January 8, 2014
• Last Update Posted: September 12, 2017
• Sponsor: University of Pennsylvania
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: January 2, 2014
• First Posted Date: January 8, 2014
• Last Update Posted Date: September 12, 2017
• Study Start Date: October 2013
• Actual Primary Completion Date: February 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 6, 2014)

Cervicovaginal Microbiota in Women With and Without Preterm Birth [ Time Frame: Enrollment through delivery ]

Cervicovaginal Microbiota in Women With and Without Preterm Birth

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 6, 2014)

Potential Modifiers of the Cervicovaginal Microbiome [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Motherhood and Microbiome
• Official Title: Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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.

• 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.
• Condition: Preterm Birth
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2017): 2000
• Original Estimated Enrollment (submitted: January 6, 2014): 1470
• Actual Study Completion Date: June 1, 2017
• Actual Primary Completion Date: February 3, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 13 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02030106
• Other Study ID Numbers: 818914; R01NR014784-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Pennsylvania
• Original Responsible Party: Michal A. Elovitz, University of Pennsylvania, Associate Professor, Director, Maternal and Child Health Research Program, Department of Obstetrics and Gynecology
• Current Study Sponsor: University of Pennsylvania
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Michal A Elovitz, MD; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: September 2017