Status:
COMPLETED
Comparison of the Safety and Efficacy of Medical Abortion Provided by Physicians and Midlevel Providers in Nepal
Lead Sponsor:
World Health Organization
Collaborating Sponsors:
Center for Research on Environment, Health and Population Activities
Conditions:
Medical Abortion
Eligibility:
FEMALE
16-50 years
Phase:
NA
Brief Summary
The purpose of the study is to compare the safety, effectiveness, and acceptability of medical abortion provided by doctors and midlevel providers in a developing country where doctors are scarce, suc...
Detailed Description
Each year, some 210 million women throughout the world become pregnant and nearly one in five chooses to terminate the pregnancy (Singh et al., 2009). Approximately, 22 million pregnancies are termina...
Eligibility Criteria
Inclusion
- Before randomization: Gestational age not more than 63 days as estimated by last menstrual period (LMP).
- After randomization: Gestational age not more than 63 days as estimated by abdominal and bimanual pelvic examination.
- Above national age of consent
- Willing to return to the clinic for misoprostol on Day 3 and for a follow-up visit on Day 10 to 14.
- Residence within the geographical area specified for each clinic and no more than one hour from emergency referral services.
- Willing to provide written informed consent to participate in the study and to be randomly assigned to a provider team.
- Able to understand the nature of the study, advice and instructions given by health providers.
Exclusion
- Previous allergic reaction to one of the drugs in the medical abortion regimen
- Known or suspected ectopic pregnancy or undiagnosed adnexal mass
- Inherited porphyria (rare genetic blood diseases)
- Chronic adrenal failure
- Long term corticosteroid therapy
- Haemorrhagic disorder or anticoagulant therapy (blood thinner medications)
- IUD in utero that can not be removed before taking mifepristone
- Previous enrolment in the study (i.e. no repeat abortions; only one abortion per woman in the study)
- Unwilling or unable to return to clinic for follow-up visit.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1104 Patients enrolled
Trial Details
Trial ID
NCT01186302
Start Date
April 1 2009
End Date
July 1 2010
Last Update
August 23 2010
Active Locations (1)
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1
Center for Research and Environmental Health and Population Activities (CREHPA)
Kathmandu, Nepal