Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion

NCT00129506 | Completed Phase 4

• 1 other identifier: c04-0636
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Unwanted Pregnancies

Keywords

medical abortion; methotrexate; misoprostol

Outcome Measures

Primary Outcomes (1)

• completion of abortion by first follow-up visit

Secondary Outcomes (3)

• surgery rate

• side effects

• acceptability

Interventions

methotrexate + misoprostol DRUG

misoprostol DRUG

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wiebe, Ellen, M.D.: lead
• Ibis Reproductive Health: collaborator

Study Sites (1)

Wiebe Early Abortion Clinic

Vancouver, British Columbia, V5Z 1H9, Canada

Location

MeSH Terms

Interventions

Methotrexate; Misoprostol

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ellen Wiebe, MD

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: October 1, 2005
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

CA (1)