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

Abortion, 3 Months Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720991
• Other study ID #: 1014
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2016
• Last updated: March 22, 2016
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, 3 Months

Intervention

Drug:
• Mifepristone
200 mg of oral mifepristone
• Sublingual misoprostol
400 ug of misoprostol sublingually following mifepristone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Hopital La Rabta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 week	No
Secondary	Level of tolerance of side effects, based on responses to questionnaire		1 week	No