A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks

NCT ID: NCT02720991

Last Updated: 2016-03-28

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

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-04-30

Brief Summary

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A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.

Detailed Description

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The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .

The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.

Conditions

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Abortion, 3 Months

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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Mifepristone and sublingual misoprostol

200 mg mifepristone and 400 ug sublingual misoprostol

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

200 mg of oral mifepristone

Sublingual misoprostol

Intervention Type DRUG

400 ug of misoprostol sublingually following mifepristone

Interventions

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Mifepristone

200 mg of oral mifepristone

Intervention Type DRUG

Sublingual misoprostol

400 ug of misoprostol sublingually following mifepristone

Intervention Type DRUG

Other Intervention Names

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miropristone Mifeprex Mifegyn cytotec

Eligibility Criteria

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Inclusion Criteria

* Gestational age of 71-84 days of amenorrhea
* Seeking abortion services
* Prepared and able to sign the consent forms
* Accept to conform to study procedures and scheduled visits

Exclusion Criteria

* Does not meet study criteria
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital La Rabta

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1014

Identifier Type: -

Identifier Source: org_study_id

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