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Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
This study is currently recruiting participants.
Study NCT00466999   Information provided by Gynuity Health Projects
First Received: April 25, 2007   Last Updated: October 1, 2009   History of Changes

April 25, 2007
October 1, 2009
May 2007
May 2010   (final data collection date for primary outcome measure)
Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ] [ Designated as safety issue: No ]
Complete abortion without recourse to surgical intervention.
Complete list of historical versions of study NCT00466999 on ClinicalTrials.gov Archive Site
 
 
 
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
 

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.

 
 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Incomplete Abortion
  • Drug: misoprostol
  • Procedure: surgery
  • Active Comparator: standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
  • Active Comparator: 400 mcg misoprostol
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
 
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Uterine size no larger than 12 weeks LMP at time of presentation for care.
  • Past or present history of vaginal bleeding during pregnancy.
  • Open cervical os.
  • If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • General good health.
  • Willing to provide contact information for purposes of follow-up.
  • Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger and Mauritania).

Exclusion Criteria:

  • Contraindications to study drug
  • Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • Hemodynamic disturbances (pulse >110/min and systolic bp <100)
  • Have an IUD in place; (the IUD may be removed making the woman eligible)
  • Suspected ectopic pregnancy
Female
 
Yes
Contact: Beverly Winikoff, MD, MPH 1-212-448-1230 bwinikoff@gynuity.org
Egypt,   Mauritania,   Niger
 
NCT00466999
Dr. Beverly Winikoff, Gynuity Health Projects
2.2.2
Gynuity Health Projects
 
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Study Director: Ayisha Diop, MPH Gynuity Health Projects
Gynuity Health Projects
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP