Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
89 participants
OBSERVATIONAL
2013-08-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: No prior preterm birth & normal cervix length
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.
No interventions assigned to this group
Group 2: No prior preterm birth & short cervix length
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.
No interventions assigned to this group
Group 3: Prior preterm birth, normal cervix length, 17-OHPC
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.
No interventions assigned to this group
Group 4: Prior preterm birth, normal cervix length, no treat
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Singleton gestation (16 0/7 - 23 6/7 weeks gestation)
* Willing to provide informed consent
* Age 18 - 50 years inclusive
Additionally,
Group 1: One or more prior term births (\>37 0/7 weeks); No prior spontaneous birth at 16 0/7 - 36 6/7 weeks; and normal cervical length (\>25 mm)
Group 2: Cervical length of 20 mm or less at 16 0/7 - 23 6/7 weeks
Groups 3 and 4: History of prior spontaneous birth at 16 0/7 - 34 0/7 weeks and normal cervical length (\> 25mm) at enrollment.
Exclusion Criteria
* Active labor
* Active bleeding
* On progestin therapy, chronic steroid, or current NSAID therapy
* Actively receiving study treatment in another clinical trial (observational trials allowed)
* Major fetal malformation lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, or serious karyotypic abnormalities
* Amniotic membranes prolapsed beyond the external os (ostium of uterus) or protruding into the vagina
* Pregnancy without a viable fetus
* Prenatal care or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)
Additionally:
Group 1: Cervical dilation greater than or equal to 3cm
Group 2: Prior preterm birth (16 0/7 - 34 0/7); active deep vein thrombosis, pulmonary embolism, or history of these conditions; known liver dysfunction or disease (active hepatitis, HIV)
Group 3: inability or unwillingness to use a 17-OHPC compounded product similar in composition to the FDA-approved product; allergy to 17-OHPC or its components
Groups 1, 3, and 4: cerclage in place or anticipated; congenital mullerian abnormality of the uterus; positive for bacterial vaginosis, chlamydia, gonorrhea, or trichomonas
Groups 3 and 4: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy, liver tumors, benign or malignant, or active liver disease; uncontrolled hypertension
18 Years
50 Years
FEMALE
Yes
Sponsors
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Indiana University
OTHER
University of Texas
OTHER
University of Washington
OTHER
RTI International
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Mary F Hebert, PharmD, FCCP
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Steve Caritis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Gary Hankins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
David Flockhart, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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OPRU Progestin
Identifier Type: -
Identifier Source: org_study_id