Overview

Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wiebe, Ellen, M.D.
Collaborator:
Ibis Reproductive Health
Treatments:
Methotrexate
Misoprostol
Criteria
Inclusion Criteria:

- Request for elective abortion

- Ability to understand the consent form

- A pregnancy of 7 weeks gestation or less on Day 1

- Documented by endovaginal ultrasound

- Willingness to comply with visit schedules

Exclusion Criteria:

- Haemoglobin less than 90 g/L

- Uncontrolled seizure disorder

- Active liver disease (aspartate aminotransferase >2x normal)

- Renal insufficiency (serum creatinine >120umol/L)

- A history of intolerance to methotrexate or misoprostol