MedTrace Logo

Precision Medicine for Preterm Birth

NCT02173210 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 380

Last updated 2018-05-02

No results posted yet for this study

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.

Conditions

  • Premature Birth

Sponsors & Collaborators

Principal Investigators

  • Michal Elovitz, MD · University of Pennsylvania

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-25
Primary Completion
2017-12-27
Completion
2017-12-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173210 on ClinicalTrials.gov