Precision Medicine for Preterm Birth

NCT02173210 | Completed

• 1 other identifier: 820143
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Birth

Keywords

Premature birth; Premature delivery; Metabolomics; Microbiota; Genetics; 17 hydroxyprogesterone caproate

Outcome Measures

Primary Outcomes (1)

• Preterm Birth

  At time of delivery

Study Arms (1)

Prior preterm birth

Pregnant women with a prior preterm birth, eligible to receive 17 hydroxyprogesterone caproate (17OHPC)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with a singleton gestation who have had a prior spontaneous preterm birth.

You may qualify if:

• 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
• weeks gestation at the time of visit 1 assessments

You may not qualify if:

• Major fetal anomaly
• Allergy to 17OHPC

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michal Elovitz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: June 25, 2014
• Primary Completion: December 27, 2017
• Study Completion: December 27, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

US (2)