Trial record 2 of 1047 for:    preterm birth

Precision Medicine for Preterm Birth (PRoMISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Michal A. Elovitz, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02173210
First received: June 23, 2014
Last updated: October 2, 2014
Last verified: October 2014
  Purpose
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
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Medicine In Segregating Endotypes in Preterm Birth

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Preterm Birth [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prior preterm birth
Pregnant women with a prior preterm birth, eligible to receive 17 hydroxyprogesterone caproate (17OHPC)

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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with a singleton gestation who have had a prior spontaneous preterm birth.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173210

Contacts
Contact: Allison Schnader 215-615-6047 OBResearch@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Michal Elovitz, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Michal A. Elovitz, Director, Maternal and Child Health Research Program, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02173210     History of Changes
Other Study ID Numbers: 820143 
Study First Received: June 23, 2014
Last Updated: October 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Premature birth
Premature delivery
Metabolomics
Microbiota
Genetics
17 hydroxyprogesterone caproate

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
11-hydroxyprogesterone
17-alpha-hydroxy-progesterone caproate
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on February 04, 2016