Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unwanted Pregnancies |
Drug: methotrexate + misoprostol Drug: misoprostol |
Phase 4 |
| Study Type: | Interventional |
| 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
- acceptability
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | October 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00129506 History of Changes |
| Other Study ID Numbers: | c04-0636 |
| Study First Received: | August 9, 2005 |
| Last Updated: | April 18, 2007 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Wiebe, Ellen, M.D.:
|
medical abortion methotrexate misoprostol |
Additional relevant MeSH terms:
|
Methotrexate Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |
ClinicalTrials.gov processed this record on September 27, 2016