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

NCT01173003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2014-02-19

No results posted yet for this study

Summary

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?

Conditions

  • Induced Abortion

Interventions

DRUG

Mifepristone, misoprostol

Sponsors & Collaborators

  • Centre de Formation et de la Recherche, Tunisia

    collaborator UNKNOWN

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Rasha Dabash, MPH · Gynuity Health Projects

  • Selma Hajri, MD · Reproductive Health Consultant

  • Mongia Ben Attia, MD · Office Nationale de la Famille et de la Population

  • N Gueddana, MD · ONFP

  • Fatma Temimi, MD · ONFP

  • E Hassairi · ONFP

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173003 on ClinicalTrials.gov