Motherhood and Microbiome
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 13 - 50 |
| Updated: | 1/12/2017 |
| Start Date: | October 2013 |
| End Date: | July 2018 |
| Contact: | Valerie M Armendariz, MS |
| Email: | Armendariz.Valerie@uphs.upenn.edu |
| Phone: | 215-498-909 |
Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth
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.
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.
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.
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.
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)
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Michal A Elovitz, MD
Phone: 215-498-9099
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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