Acceptability and Feasibility of Medical Abortion in Singapore

• Sponsor: Gynuity Health Projects (Other)
• Overall Status: Completed
• CT.gov ID: NCT02985229
• Collaborator: (none)
• Enrollment: 130
• Locations: 2
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 65
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Abortion	Drug: Mifepristone; Drug: Misoprostol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Mifepristone; The option of home or clinic administration of 200 mg oral mifepristone; Drug: Misoprostol; 800 μg buccal misoprostol through 70 days LMP following administration of mifepristone

Outcome Measures

Primary Outcome Measures

1. Rate of successful abortion [7-10 days after mifepristone administration]

   Proportion of abortions that are complete without surgical intervention

Secondary Outcome Measures

1. Satisfaction with the medical abortion method [7-10 days after mifepristone administration]

   Proportion of women who are satisfied with the medical abortion method

2. Preferred location of mifepristone administration [The day of enrollment]

   Proportion of women who select home use of mifepristone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KK Women's and Children's Hospital	Singapore		Singapore
2	National University Hospital	Singapore		Singapore

Sponsors and Collaborators

• Gynuity Health Projects

Investigators

• Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT02985229
• Other Study ID Numbers: 1028
• First Posted: Dec 7, 2016
• Last Update Posted: Apr 6, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Misoprostol; Mifepristone

Study Results

No Results Posted as of Apr 6, 2018