Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)
- Registration Number
- NCT00870272
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of \<63 days will be offered the option of participating in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 550
Inclusion Criteria
- Gestational age less than or equal to 63 days
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
- Willing to provide an address and/or telephone number for purposes of follow-up.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Misoprostol 400mcg sublingual misoprostol 2 Misoprostol 400mcg buccal misoprostol
- Primary Outcome Measures
Name Time Method Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration July 2007-March 2009
- Secondary Outcome Measures
Name Time Method Side effects experienced July 2007- March 2009
Trial Locations
- Locations (1)
State University of Medicine and Pharmacy
🇲🇩Chisinau, Moldova, Republic of