Motherhood and Microbiome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Birth

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prior Preterm Birth Patients<br>All obstetrical patients eligible for the study that have had a prior preterm birth. | |
| Term Birth Patients<br>All obstetrical patients eligible for the study that have not had a prior preterm birth. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervicovaginal Microbiota in Women With and Without Preterm Birth | Cervicovaginal Microbiota in Women With and Without Preterm Birth | Enrollment through delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential Modifiers of the Cervicovaginal Microbiome | 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 | Enrollment through delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Remodeling, Microbiota, Cervicovaginal microbiome, Microbiome, Preterm Birth, Preterm delivery