Precision Medicine for Preterm Birth
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/4/2018 |
| Start Date: | June 25, 2014 |
| End Date: | December 27, 2017 |
Precision Medicine In Segregating Endotypes in Preterm Birth
This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone
caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been
associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation.
However, it is not well known why it works for some women but not for others. There are
limited available interventions for the prevention of recurrent PTB. This study will enroll
150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC
and 20% will decline use. We will obtain blood samples and samples of cervical cells and
cervical vaginal fluid. The objective of the study is to identify genetic, microbial and
molecular markers that help to identify which women at risk for recurrent preterm birth will
respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized
screening test based on these markers.
caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been
associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation.
However, it is not well known why it works for some women but not for others. There are
limited available interventions for the prevention of recurrent PTB. This study will enroll
150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC
and 20% will decline use. We will obtain blood samples and samples of cervical cells and
cervical vaginal fluid. The objective of the study is to identify genetic, microbial and
molecular markers that help to identify which women at risk for recurrent preterm birth will
respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized
screening test based on these markers.
Women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. At this
initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be
collected. Approximately 8 weeks later, those samples will be collected a second time, along
with a blood sample. Outcome data will be collected after delivery.
initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be
collected. Approximately 8 weeks later, those samples will be collected a second time, along
with a blood sample. Outcome data will be collected after delivery.
Inclusion Criteria:
- Women with a prior spontaneous preterm birth of a singleton pregnancy (delivered at
16-36 6/7 weeks gestation)
- Singleton in the current pregnancy
- Eligible to use 17 hydroxyprogesterone caproate (17OHPC) in this pregnancy for
clinical indications
- 16-22 weeks gestation at the time of visit 1 assessments
Exclusion Criteria:
- Major fetal anomaly
- Allergy to 17OHPC
We found this trial at
2
sites
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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