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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WITHDRAWN
PHASE1
INTERVENTIONAL
2008-03-31
2010-10-31
Brief Summary
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The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Mifepristone followed by labor induction with misoprostol after 6-8 hours
Experimental (mifepristone and misoprostol)
Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
Interventions
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Experimental (mifepristone and misoprostol)
Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
Eligibility Criteria
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Inclusion Criteria
* 18 years of age and above
* Voluntarily choose to undergo pregnancy termination via labor induction
* An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
* Able to provide written consent
Exclusion Criteria
* Preterm labor
* Intrauterine fetal demise
* Chronic systemic corticosteroid use or adrenal disease
* Hypersensitivity to prostaglandins
* Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
* Known coagulopathy or treatment with anticoagulants
* Prior caesarean delivery or myomectomy
* Placenta previa
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Maryland
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Rameet Singh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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2007-663
Identifier Type: -
Identifier Source: secondary_id
NA_00010268
Identifier Type: -
Identifier Source: org_study_id