- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02173210
Precision Medicine for Preterm Birth (PRoMISE)
May 1, 2018 updated by: University of Pennsylvania
Precision Medicine In Segregating Endotypes in 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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
380
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women with a singleton gestation who have had a prior spontaneous preterm birth.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Prior preterm birth
Pregnant women with a prior preterm birth, eligible to receive 17 hydroxyprogesterone caproate (17OHPC)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Preterm Birth
Time Frame: At time of delivery
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At time of delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michal Elovitz, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2014
Primary Completion (Actual)
December 27, 2017
Study Completion (Actual)
December 27, 2017
Study Registration Dates
First Submitted
June 23, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 820143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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