PRoMISE: Precision Medicine for Preterm Birth

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT02173210

Collaborator

(none)

380

Enrollment

Locations

42.1

Actual Duration (Months)

190

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

380 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Precision Medicine In Segregating Endotypes in Preterm Birth

Actual Study Start Date :

Jun 25, 2014

Actual Primary Completion Date :

Dec 27, 2017

Actual Study Completion Date :

Dec 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Prior preterm birth Pregnant women with a prior preterm birth, eligible to receive 17 hydroxyprogesterone caproate (17OHPC)

Outcome Measures

Primary Outcome Measures

Preterm Birth [At time of delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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