A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
1 other identifier
interventional
1,200
1 country
8
Brief Summary
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 10, 2006
CompletedFirst Posted
Study publicly available on registry
October 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJune 5, 2007
June 1, 2007
October 10, 2006
June 1, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy
Secondary Outcomes (1)
acceptability
Interventions
Eligibility Criteria
You may qualify if:
- be willing and able to sign consent forms;
- 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.
You may not qualify if:
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Related Publications (1)
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.
PMID: 19037040DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, MD, MPH
Gynuity Health Projects
- STUDY DIRECTOR
Ilana Dzuba, MHS
Gynuity Health Projects
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2006
First Posted
October 12, 2006
Study Start
October 1, 2006
Study Completion
March 1, 2007
Last Updated
June 5, 2007
Record last verified: 2007-06