Skip to main content
OpenTrials
Completed

NCT Number: NCT02985229

Acceptability and Feasibility of Medical Abortion in Singapore

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Medical Abortion

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

KK Women's and Children's Hospital, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mifepristone

Drug

The option of home or clinic administration of 200 mg oral mifepristone

Misoprostol

Drug

800 μg buccal misoprostol through 70 days LMP following administration of mifepristone

Primary outcomes

  1. Rate of successful abortion

    Time frame: 7-10 days after mifepristone administration

    Proportion of abortions that are complete without surgical intervention

Secondary outcomes

  1. Satisfaction with the medical abortion method

    Time frame: 7-10 days after mifepristone administration

    Proportion of women who are satisfied with the medical abortion method

  2. Preferred location of mifepristone administration

    Time frame: The day of enrollment

    Proportion of women who select home use of mifepristone

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2016
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.