Acceptability and Feasibility of Medical Abortion in Singapore
1 other identifier
interventional
130
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 6, 2018
April 1, 2018
9 months
October 19, 2016
April 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of successful abortion
Proportion of abortions that are complete without surgical intervention
7-10 days after mifepristone administration
Secondary Outcomes (2)
Satisfaction with the medical abortion method
7-10 days after mifepristone administration
Preferred location of mifepristone administration
The day of enrollment
Study Arms (1)
All participants
EXPERIMENTALAll 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.
Interventions
The option of home or clinic administration of 200 mg oral mifepristone
800 μg buccal misoprostol through 70 days LMP following administration of mifepristone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
KK Women's and Children's Hospital
Singapore, Singapore
National University Hospital
Singapore, Singapore
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, MD, MPH
Gynuity Health Projects
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2016
First Posted
December 7, 2016
Study Start
October 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 6, 2018
Record last verified: 2018-04