Acceptability and Feasibility of Medical Abortion in Singapore

Medical Abortion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985229
• Other study ID #: 1028
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2016
• Last updated: April 4, 2018
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• Mifepristone
The option of home or clinic administration of 200 mg oral mifepristone
• Misoprostol
800 µg buccal misoprostol through 70 days LMP following administration of mifepristone

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion	Proportion of abortions that are complete without surgical intervention	7-10 days after mifepristone administration
Secondary	Satisfaction with the medical abortion method	Proportion of women who are satisfied with the medical abortion method	7-10 days after mifepristone administration
Secondary	Preferred location of mifepristone administration	Proportion of women who select home use of mifepristone	The day of enrollment