Comparative Effectiveness of Pregnancy Failure Management Regimens
NCT ID: NCT02012491
Last Updated: 2019-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2014-01-31
2019-06-15
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
TREATMENT
DOUBLE
Study Groups
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misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Misoprostol
Mifepristone
misoprostol
800 micrograms of vaginal misoprostol alone
Misoprostol
Interventions
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Misoprostol
Mifepristone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* hemodynamically stable
* confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
* willing and able to give informed consent
Exclusion Criteria
* contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
* contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
* cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
* most recent hemoglobin \<9.5 g/dL
* diagnosis of porphyria
* known clotting defect or receiving anticoagulants
* pregnancy with an intrauterine device (IUD) in place
* breastfeeding during the first 7 days of study participation
* unwilling to comply with the study protocol and visit schedule
* any evidence of viable pregnancy
* possibility of ectopic pregnancy
* known or suspected pelvic infection
* concurrent participation in any other interventional trial
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Courtney A Schreiber, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Mitchell Creinin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Nagendra D, Gutman SM, Koelper NC, Loza-Avalos SE, Sonalkar S, Schreiber CA, Harvie HS. Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration. Am J Obstet Gynecol. 2022 Nov;227(5):737.e1-737.e11. doi: 10.1016/j.ajog.2022.06.054. Epub 2022 Jun 30.
Roe AH, McAllister A, Flynn AN, Martin B, Jiang E, Koelper N, Schreiber CA. The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss. Contraception. 2021 Oct;104(4):432-436. doi: 10.1016/j.contraception.2021.04.023. Epub 2021 Apr 28.
Shorter JM, Koelper N, Sonalkar S, Oquendo MA, Sammel MD, Schreiber CA. Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss. Obstet Gynecol. 2021 Jan 1;137(1):156-163. doi: 10.1097/AOG.0000000000004212.
Sonalkar S, Koelper N, Creinin MD, Atrio JM, Sammel MD, McAllister A, Schreiber CA. Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial. Am J Obstet Gynecol. 2020 Oct;223(4):551.e1-551.e7. doi: 10.1016/j.ajog.2020.04.006. Epub 2020 Apr 17.
Nagendra D, Koelper N, Loza-Avalos SE, Sonalkar S, Chen M, Atrio J, Schreiber CA, Harvie HS. Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201594. doi: 10.1001/jamanetworkopen.2020.1594.
Clement EG, Horvath S, McAllister A, Koelper NC, Sammel MD, Schreiber CA. The Language of First-Trimester Nonviable Pregnancy: Patient-Reported Preferences and Clarity. Obstet Gynecol. 2019 Jan;133(1):149-154. doi: 10.1097/AOG.0000000000002997.
Schreiber CA, Creinin MD, Atrio J, Sonalkar S, Ratcliffe SJ, Barnhart KT. Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med. 2018 Jun 7;378(23):2161-2170. doi: 10.1056/NEJMoa1715726.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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818434
Identifier Type: -
Identifier Source: org_study_id
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