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

This study has been completed.
Sponsor:
Collaborator:
Centre de Formation et de la Recherche, Tunisia
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01173003
First received: July 28, 2010
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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?

Condition Intervention
Induced Abortion
Drug: Mifepristone, misoprostol

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Acceptability for women [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 688
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173003

Locations
Tunisia
Centres (14) de Planification Familiale de L'ONFP
Tunis, Various, Tunisia
Sponsors and Collaborators
Gynuity Health Projects
Centre de Formation et de la Recherche, Tunisia
Investigators
Study Chair: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Principal Investigator: Selma Hajri, MD Reproductive Health Consultant
Principal Investigator: Mongia Ben Attia, MD Office Nationale de la Famille et de la Population
Study Chair: N Gueddana, MD ONFP
Principal Investigator: Fatma Temimi, MD ONFP
Principal Investigator: E Hassairi ONFP
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01173003     History of Changes
Other Study ID Numbers: 1.1.7
Study First Received: July 28, 2010
Last Updated: February 18, 2014
Health Authority: Tunisia: Comite de l'Office Nationale de la Famille et la Population

Keywords provided by Gynuity Health Projects:
Medical abortion
mifepristone
misoprostol
Tunisia

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on July 28, 2014