A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
NCT ID: NCT00386867
Last Updated: 2007-06-05
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
NA
1200 participants
INTERVENTIONAL
2006-10-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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800 mcg misoprostol via oral or buccal administration
Eligibility Criteria
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Inclusion Criteria
* be eligible for medical abortion according to clinician's assessment;
* be willing to undergo a surgical completion if necessary;
* have ready and easy access to a telephone and emergency transportation;
* speak English, Spanish, or have a translator available to translate for all study procedures; and,
* agree to comply with the study procedures and visit schedule.
Exclusion Criteria
* IUD in place;
* Chronic renal failure;
* Concurrent long-term corticosteroid therapy;
* History of allergy to mifepristone, misoprostol or other prostaglandin;
* Hemorrhagic disorders or concurrent anticoagulant therapy;
* Inherited porphyrias; or
* Other serious physical or mental health conditions.
18 Years
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Principal Investigators
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Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Ilana Dzuba, MHS
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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Family Planning Associates Medical Group
Chicago, Illinois, United States
Planned Parenthood League of Massachusetts (Boston clinic)
Boston, Massachusetts, United States
Columbia University Medical Center, Division of Obstetrics & Gynecology
New York, New York, United States
Institute for Urban Family Health
New York, New York, United States
Parkmed
New York, New York, United States
University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
Pittsburgh, Pennsylvania, United States
Whole Women's Health
Austin, Texas, United States
Planned Parenthood
Waco, Texas, United States
Countries
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References
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Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.
Related Links
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Related Info
Other Identifiers
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1.1.3
Identifier Type: -
Identifier Source: org_study_id