NCT01954095|CompletedDMC
The Impact of Vaginal and IM Progestins on the Cervix
Determining the Pharmacodynamic Impact of Vaginal and IM Progestins on the Cervix
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Determining the Pharmacodynamic Impact of Vaginal and IM Progestins on the Cervix
Sponsor study identifier
observational
89
1 country
4
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
March 2015
Actual (reported)The purpose of this study is to analyze how the body handles and responds to progesterone treatment in parous and nulliparous women at risk of pre-term birth.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 26, 2013
Actual (reported)October 1, 2013
Actual (reported)January 2015
Actual (reported)March 2015
Actual (reported)Biomarkers
Proteins in the cervicovaginal fluid with expression changes two-fold or greater between day 0 and week 2 of either vaginal or IM progestin therapy.
2 Weeks
Cervical sonographic changes
8 Weeks
Protein Expression
8 Weeks
Cervical cytokines
8 Weeks
Individual cytokines
8 Weeks
Cervical MMPs
8 Weeks
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had one or more term births (no prior preterm births) and have a normal cervical length (\> 25 mm). These women will serve as gestational age controls for all groups.
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have no prior preterm births and have a short cervical length (20mm or less). These women may receive treatment (e.g. vaginal progesterone, cerclage, pessary, NSAIDs, or a combination thereof) or no treatment.
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length and will receive 17-OHPC treatment.
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length, and will not receive any treatment. These women will serve as controls for Group 3.
This study consists of 4 groups of women who are between 16 0/7 - 23 6/7 weeks gestation. The allocation of a subject to a group is based on two objective assessments (history of preterm birth and cervical length) and the joint clinical decision of the woman and her physician regarding treatment options. Study participants who have no prior preterm births and a normal cervical length will be assigned to Group 1. If the participant has no prior preterm births and a short cervical length, she will be assigned to Group 2 regardless of treatment or no treatment. Group assignment for women with a prior preterm birth and normal cervical length is based on 17-OHPC use. Participants who elect to use 17-OHPC will be assigned to Group 3 and those who choose not to receive any treatment will be assigned to Group 4.
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Washington
Seattle, Washington, 98195, United States
Blood for DNA extraction, hormone, and metabolomic analyses Cervicovaginal fluid for proteome, cytokines, and matrix metalloproteins (MMPs)
Mary F Hebert, PharmD, FCCP
University of Washington
Steve Caritis, MD
University of Pittsburgh
Gary Hankins, MD
University of Texas
David Flockhart, MD, PhD
Indiana University
89 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2013
First Posted
October 1, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Precision Medicine for Preterm Birth
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
December 2, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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