Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
Participant gender:
Summary
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.