NCT02173210: PRoMISE

Precision Medicine for Preterm Birth

Completed Last updated 2 May 2018

What this trial tests

trial in Premature Birth in 380 participants. Completed in 27 December 2017.

Timeline

25 June 2014

Primary endpoint
27 December 2017

27 December 2017

Quick facts

Lead sponsor	University of Pennsylvania
Status	Completed
Study type	OBSERVATIONAL
Enrollment	380
Start date	25 June 2014
Primary completion	27 December 2017
Estimated completion	27 December 2017
Sites	2 locations across United States

Conditions studied

• Premature Birth — all drugs for Premature Birth →

Sponsor

University of Pennsylvania

Who can join

Eligibility, female only, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enabling Technologies for Personalized and Precision Medicine.
   Ho D, Quake SR, McCabe ERB, Chng WJ, et al · · 2020 · cited 241× · PMID 31980301 · DOI 10.1016/j.tibtech.2019.12.021