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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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
Study Start Date : October 2013
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : June 1, 2017
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Cervicovaginal Microbiota in Women With and Without Preterm Birth [ Time Frame: Enrollment through delivery ]
    Cervicovaginal Microbiota in Women With and Without Preterm Birth


Secondary Outcome Measures :
  1. 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


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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030106


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Michal A Elovitz, MD University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02030106    
Other Study ID Numbers: 818914
R01NR014784-01 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Keywords provided by University of Pennsylvania:
Cervicovaginal microbiome
Microbiome
Preterm Birth
 Cervical Remodeling
Preterm delivery
Microbiota
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases