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

Completed · Not applicable

Conditions studied: Abortion, Induced

In brief

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.

Key facts

Study ID

NCT00386867

Run by

Gynuity Health Projects

People needed

1200

Starts

2006-10-01

Expected to finish

2007-03-01

Last updated by the study team

2007-06-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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