Acceptability and Feasibility of Medical Abortion in Singapore

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

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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion
• Intervention / Treatment: Drug: Mifepristone; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful abortion	Proportion of abortions that are complete without surgical intervention	7-10 days after mifepristone administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (ESTIMATE): December 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1028