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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. Identifier: NCT00129506
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : June 11, 2018
Ibis Reproductive Health
Information provided by (Responsible Party):
Ellen R Wiebe, MD, Wiebe, Ellen, M.D.

Brief 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.

Condition or disease Intervention/treatment Phase
Unwanted Pregnancies Drug: methotrexate + misoprostol Drug: misoprostol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. completion of abortion by first follow-up visit

Secondary Outcome Measures :
  1. surgery rate
  2. side effects
  3. acceptability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00129506

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Canada, British Columbia
Wiebe Early Abortion Clinic
Vancouver, British Columbia, Canada, V5Z 1H9
Sponsors and Collaborators
Wiebe, Ellen, M.D.
Ibis Reproductive Health
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Principal Investigator: Ellen Wiebe, MD UBC
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Responsible Party: Ellen R Wiebe, MD, Principal Investigator, Wiebe, Ellen, M.D. Identifier: NCT00129506    
Other Study ID Numbers: c04-0636
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Keywords provided by Ellen R Wiebe, MD, Wiebe, Ellen, M.D.:
medical abortion
Additional relevant MeSH terms:
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Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
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