Acceptability and Feasibility of Medical Abortion in Sing... | NCT02985229

Studies
Acceptability and Feasibility of Medical Abortion in Singapore

NCT02985229

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

130Actual

Phase

Phase 3

Conditions

Medical Abortion

Interventions

Mifepristone
Misoprostol

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants	Experimental	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 Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mifepristone	Drug	The option of home or clinic administration of 200 mg oral mifepristone	All participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beverly Winikoff, MD, MPH	Gynuity Health Projects	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital		Singapore			Singapore
National University Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D015735	Mifepristone
D016595	Misoprostol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided