Acceptability and Feasibility of Medical Abortion in Singapore

Phase 3

Completed

• Conditions: Medical Abortion
• Interventions: Drug: Mifepristone; Drug: Misoprostol

• Registration Number: NCT02985229
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Misoprostol	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.
All participants	Mifepristone	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.

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion	7-10 days after mifepristone administration	Proportion of abortions that are complete without surgical intervention

Secondary Outcome Measures

Name	Time	Method
Preferred location of mifepristone administration	The day of enrollment	Proportion of women who select home use of mifepristone
Satisfaction with the medical abortion method	7-10 days after mifepristone administration	Proportion of women who are satisfied with the medical abortion method

Trial Locations

Locations (2)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore