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

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. Identifier: NCT02720991
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Hopital La Rabta
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abortion, 3 Months Drug: Mifepristone Drug: Sublingual misoprostol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

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:
  • miropristone
  • Mifeprex
  • Mifegyn

Drug: Sublingual misoprostol
400 ug of misoprostol sublingually following mifepristone
Other Name: cytotec

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Level of tolerance of side effects, based on responses to questionnaire [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: Gynuity Health Projects Identifier: NCT02720991    
Other Study ID Numbers: 1014
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
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