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NCT02173210 Clinical Trial

Precision Medicine for Preterm Birth

Premature Birth Clinical Trial

— PRoMISE  

Official title:
Precision Medicine In Segregating Endotypes in Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02173210
Other study ID # 820143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2014
Est. completion date December 27, 2017

Study information
Verified date May 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 380
Est. completion date December 27, 2017
Est. primary completion date December 27, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm Birth At time of delivery
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