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 : June 11, 2018

Sponsor:

Collaborator:

Ibis Reproductive Health

Information provided by (Responsible Party):

Ellen R Wiebe, MD, Wiebe, Ellen, M.D.

Study Description

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)
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

Drug Information available for: Methotrexate Misoprostol

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

completion of abortion by first follow-up visit

Secondary Outcome Measures :

surgery rate
side effects
acceptability

Eligibility Criteria

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00129506

Locations

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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

Investigators

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Principal Investigator:	Ellen Wiebe, MD	UBC

More Information

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Responsible Party:	Ellen R Wiebe, MD, Principal Investigator, Wiebe, Ellen, M.D.
ClinicalTrials.gov Identifier:	NCT00129506 History of Changes
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 methotrexate misoprostol

Additional relevant MeSH terms:

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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

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