Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion

This study has been completed.
Sponsor:
Collaborator:
Ibis Reproductive Health
Information provided by:
Wiebe, Ellen, M.D.
ClinicalTrials.gov Identifier:
NCT00129506
First received: August 9, 2005
Last updated: April 18, 2007
Last verified: April 2007
  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

Resource links provided by NLM:


Further study details as provided by Wiebe, Ellen, M.D.:

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

Secondary Outcome Measures:
  • 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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129506

Locations
Canada, British Columbia
Wiebe Early Abortion Clinic
Vancouver, British Columbia, Canada, V5Z 1H9
Sponsors and Collaborators
Wiebe, Ellen, M.D.
Ibis Reproductive Health
Investigators
Principal Investigator: Ellen Wiebe, MD UBC
  More Information

No publications provided

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
Pharmacologic Actions
Therapeutic Uses
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 April 17, 2014