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Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion

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ClinicalTrials.gov Identifier: NCT00129506
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : April 19, 2007
Sponsor:
Collaborator:
Ibis Reproductive Health
Information provided by:
Wiebe, Ellen, M.D.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : May 2005
Study Completion Date : October 2005

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

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

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00129506     History of Changes
Other Study ID Numbers: c04-0636
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

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