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

March 22, 2016 updated by: Gynuity Health Projects

A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone and sublingual misoprostol
200 mg mifepristone and 400 ug sublingual misoprostol
Drug: Mifepristone
200 mg of oral mifepristone
Other Names:
  • Mifeprex
  • miropristone
  • Mifegyn
Drug: Sublingual misoprostol
400 ug of misoprostol sublingually following mifepristone
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Level of tolerance of side effects, based on responses to questionnaire
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Hopital La Rabta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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