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Acceptability and Feasibility of Medical Abortion in Singapore

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985229
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of successful abortion [ Time Frame: 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 [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985229


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02985229    
Other Study ID Numbers: 1028
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents