Clinical trial NCT02030106: Motherhood and Microbiome
Official title: Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Cervicovaginal microbiome
Microbiome
Preterm Birth
Cervical Remodeling
Preterm delivery
Microbiota
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-01-08
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Cervicovaginal Microbiota in Women With and Without Preterm Birth
timeFrame: Enrollment through delivery
Secondary outcomes:
measure: Potential Modifiers of the Cervicovaginal Microbiome
timeFrame: Enrollment through delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michal A Elovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: