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OpenTrials
Completed

NCT Number: NCT02173210

Precision Medicine for Preterm Birth

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Preterm Birth

    Time frame: At time of delivery

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Precision Medicine In Segregating Endotypes in Preterm Birth

Acronym: PRoMISE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2014
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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