Status:
COMPLETED
Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
Lead Sponsor:
Wiebe, Ellen, M.D.
Collaborating Sponsors:
Ibis Reproductive Health
Conditions:
Unwanted Pregnancies
Eligibility:
FEMALE
16-60 years
Phase:
PHASE4
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 impo...
Detailed Description
Background/Rationale: Medical abortions induced with either mifepristone or methotrexate and then followed by misoprostol are becoming more common. Although mifepristone is the preferred drug used to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00129506
Start Date
May 1 2005
End Date
October 1 2005
Last Update
June 11 2018
Active Locations (1)
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1
Wiebe Early Abortion Clinic
Vancouver, British Columbia, Canada, V5Z 1H9