Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation
Overview
- Phase
- Phase 3
- Intervention
- Mifepristone
- Conditions
- Medical Abortion
- Sponsor
- Gynuity Health Projects
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Rate of successful abortion
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days
- •Be 21 years of age or over
- •Be willing and able to sign consent forms
- •Be eligible for abortion according to current hospital guidelines
- •Be able to return to the clinic and able to contact study staff or emergency medical services if needed
- •Be willing to provide an address, email and/or telephone number for purposes of follow-up
- •Agree to comply with the study procedures and visit schedule
Exclusion Criteria
- •confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- •chronic renal failure
- •concurrent long-term corticosteroid therapy
- •history of inherited porphyrias
- •IUD in place (must be removed after mifepristone is administered).
Arms & Interventions
All participants
All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.
Intervention: Mifepristone
All participants
All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion.
Intervention: Misoprostol
Outcomes
Primary Outcomes
Rate of successful abortion
Time Frame: 7-10 days after mifepristone administration
Proportion of abortions that are complete without surgical intervention
Secondary Outcomes
- Preferred location of mifepristone administration(The day of enrollment)
- Satisfaction with the medical abortion method(7-10 days after mifepristone administration)