A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

Not Applicable

Completed

• Conditions: Abortion, Induced

• Registration Number: NCT00386867
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-12
• Study Completion: 2007-03
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-01
• Last Update Posted: 2007-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
efficacy

Secondary Outcome Measures

Name	Time	Method
acceptability

Trial Locations

Locations (8)

Institute for Urban Family Health; 🇺🇸 New York, New York, United States

University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences; 🇺🇸 Pittsburgh, Pennsylvania, United States

Columbia University Medical Center, Division of Obstetrics & Gynecology; 🇺🇸 New York, New York, United States

Parkmed; 🇺🇸 New York, New York, United States

Whole Women's Health; 🇺🇸 Austin, Texas, United States

Planned Parenthood; 🇺🇸 Waco, Texas, United States

Planned Parenthood League of Massachusetts (Boston clinic); 🇺🇸 Boston, Massachusetts, United States

Family Planning Associates Medical Group; 🇺🇸 Chicago, Illinois, United States