Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00466999
First received: April 25, 2007
Last updated: March 28, 2012
Last verified: March 2012

April 25, 2007
March 28, 2012
February 2007
November 2009   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Incomplete Abortion
  • Drug: misoprostol
    single dose of 400 mcg misoprostol administered sublingually
  • Procedure: surgery
    standard surgical treatment (dilation and curettage or manual vacuum aspiration)
  • Active Comparator: surgery
    standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
    Intervention: Procedure: surgery
  • Active Comparator: misoprostol
    400 mcg misoprostol
    Intervention: Drug: misoprostol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
November 2009
November 2009   (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, Mauritania and Senegal).

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
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Egypt,   Mauritania,   Niger,   Senegal
 
NCT00466999
2.2.2
No
Gynuity Health Projects
Gynuity Health Projects
Not Provided
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
March 2012

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