Acceptability and Feasibility of Medical Abortion in Singapore

NCT ID: NCT02985229

Last Updated: 2018-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Medical Abortion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

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

Misoprostol

Intervention Type DRUG

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

Interventions

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Mifepristone

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

Intervention Type DRUG

Misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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1028

Identifier Type: -

Identifier Source: org_study_id

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