Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
Background: In most countries in which abortion is legal, medical abortions are induced with mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many countries, it is important to find other regimens. Methotrexate, which is used with misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is inexpensive and available in almost all countries. A report from Nigeria found that 98% of 100 women aborted within 24 hours of using misoprostol given both sublingually and vaginally.
Method: This will be a randomized controlled trial of the usual regimen used in Canada, methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal misoprostol. The main outcome measure will be a completed abortion within the first week with secondary outcome measures including total surgery rate, time to abortion, complications, pain, side effects and patient satisfaction.
Rationale: If the investigators can find an inexpensive, easily available, method of medical abortion, it will save many lives in third world countries.
Drug: methotrexate + misoprostol
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion|
- completion of abortion by first follow-up visit
- surgery rate
- side effects
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||October 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129506
|Canada, British Columbia|
|Wiebe Early Abortion Clinic|
|Vancouver, British Columbia, Canada, V5Z 1H9|
|Principal Investigator:||Ellen Wiebe, MD||UBC|