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Precision Medicine for Preterm Birth (PRoMISE)

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ClinicalTrials.gov Identifier: NCT02173210
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease
Premature Birth

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.

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Study Type : Observational
Actual Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Medicine In Segregating Endotypes in Preterm Birth
Actual Study Start Date : June 25, 2014
Actual Primary Completion Date : December 27, 2017
Actual Study Completion Date : December 27, 2017

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



Primary Outcome Measures :
  1. Preterm Birth [ Time Frame: At time of delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173210


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

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02173210     History of Changes
Other Study ID Numbers: 820143
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Keywords provided by University of Pennsylvania:
Premature birth
Premature delivery
Metabolomics
Microbiota
Genetics
17 hydroxyprogesterone caproate
Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones