Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00129506|
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : June 11, 2018
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 or disease||Intervention/treatment||Phase|
|Unwanted Pregnancies||Drug: methotrexate + misoprostol Drug: misoprostol||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion|
|Actual Study Start Date :||May 2005|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||October 2005|
- completion of abortion by first follow-up visit
- surgery rate
- side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129506
|Canada, British Columbia|
|Wiebe Early Abortion Clinic|
|Vancouver, British Columbia, Canada, V5Z 1H9|
|Principal Investigator:||Ellen Wiebe, MD||UBC|