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Motherhood and Microbiome (M&M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02030106
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : September 12, 2017
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
Change History
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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2017)
Original Estimated Enrollment
 (submitted: January 6, 2014)
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)
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
Removed Location Countries  
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)
Principal Investigator: Michal A Elovitz, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date September 2017