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OpenTrials
Completed

NCT Number: NCT02030106

Motherhood and Microbiome

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

13 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: M&M

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2014
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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