Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
NCT ID: NCT02412618
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2012-09-30
2014-01-31
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
TRIPLE
Study Groups
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Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Mifepristone
Progesterone antagonist
Misoprostol
Prostaglandin E1
Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Misoprostol
Prostaglandin E1
Placebo
Tasteless, odorless, sugar based pill
Interventions
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Mifepristone
Progesterone antagonist
Misoprostol
Prostaglandin E1
Placebo
Tasteless, odorless, sugar based pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eligible for non---urgent D\&E
* 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
Exclusion Criteria
* fetal demise
* intolerance
* allergy or contraindication to mifepristone or misoprostol
18 Years
50 Years
FEMALE
Yes
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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References
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Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4.
Other Identifiers
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2012-245
Identifier Type: -
Identifier Source: org_study_id
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