Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
NCT ID: NCT02913495
Last Updated: 2021-10-13
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
PHASE4
205 participants
INTERVENTIONAL
2016-09-30
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vaginal Progesterone
200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery
Vaginal Progesterone
Intramuscular Progesterone
250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.
Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)
Interventions
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Vaginal Progesterone
Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Estimated gestational age less than 24 0/7 weeks
* Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
* Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
Exclusion Criteria
* A contraindication to progesterone treatment;
* Placenta previa or accreta;
* Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
* Multifetal gestation;
* Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment
18 Years
FEMALE
Yes
Sponsors
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Baystate Medical Center
OTHER
George Washington University
OTHER
Vriginia Commonwealth University
UNKNOWN
Ohio State University
OTHER
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Rupsa C Boelig, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University Hospital; Sidney Kimmel Medical College
Locations
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George Washington University
Washington D.C., District of Columbia, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. doi: 10.1097/AOG.0b013e3182723b1b. No abstract available.
Saccone G, Khalifeh A, Elimian A, Bahrami E, Chaman-Ara K, Bahrami MA, Berghella V. Vaginal progesterone vs intramuscular 17alpha-hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Mar;49(3):315-321. doi: 10.1002/uog.17245. Epub 2017 Feb 6.
Boelig RC, Schoen CN, Frey H, Gimovsky AC, Springel E, Backley S, Berghella V. Vaginal progesterone vs intramuscular 17-hydroxyprogesterone caproate for prevention of recurrent preterm birth: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):722.e1-722.e12. doi: 10.1016/j.ajog.2022.02.012. Epub 2022 Feb 19.
Other Identifiers
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16D.542
Identifier Type: -
Identifier Source: org_study_id