NCT01173003

Brief 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. 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. 2.Are the side effects with sublingual use tolerable for women?
  3. 3.Is sublingual administration of misoprostol acceptable to women?
  4. 4.Are women satisfied with counseling and services received in new centers offering medical abortion?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
688

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.5 years

First QC Date

July 28, 2010

Last Update Submit

February 18, 2014

Conditions

Induced Abortion

Keywords

Medical abortionmifepristonemisoprostolTunisia

Outcome Measures

Primary Outcomes (1)

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

    2 weeks after mifepristone administration

Secondary Outcomes (2)

  • Side effects

    48 hours

  • Acceptability for women

    2 weeks

Interventions

Mifepristone, misoprostolDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centres (14) de Planification Familiale de L'ONFP

Tunis, Various, Tunisia

Location

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    STUDY CHAIR

  • Rasha Dabash, MPH

    Gynuity Health Projects

    STUDY DIRECTOR

  • Selma Hajri, MD

    Reproductive Health Consultant

    PRINCIPAL INVESTIGATOR

  • Mongia Ben Attia, MD

    Office Nationale de la Famille et de la Population

    PRINCIPAL INVESTIGATOR

  • N Gueddana, MD

    ONFP

    STUDY CHAIR

  • Fatma Temimi, MD

    ONFP

    PRINCIPAL INVESTIGATOR

  • E Hassairi

    ONFP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

TU(1)