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OpenTrials
Completed

NCT Number: NCT01173003

Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

The goal of this study is to provide answers to the following four questions:

1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)? 2. Are the side effects with sublingual use tolerable for women? 3. Is sublingual administration of misoprostol acceptable to women? 4. Are women satisfied with counseling and services received in new centers offering medical abortion?

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Key information

Conditions

Induced Abortion

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centres (14) de Planification Familiale de L'ONFP

Tunis, Various, Tunisia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women presenting for medical abortion who consent to participate
  • Possibility of final gestational age of less than or equal to 63 days
  • General good health
  • Willing to provide contact information for purposes of follow-up

Exclusion criteria

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate

Treatment and study plan

Mifepristone, misoprostol

Drug

Primary outcomes

  1. Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.

    Time frame: 2 weeks after mifepristone administration

Secondary outcomes

  1. Side effects

    Time frame: 48 hours

  2. Acceptability for women

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Centre de Formation et de la Recherche, Tunisia

Registry information

Official study title

An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2010
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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