Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

This study has been completed.
Sponsor:
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00674232
First received: April 28, 2008
Last updated: May 5, 2008
Last verified: May 2008

April 28, 2008
May 5, 2008
May 2006
Not Provided
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason [ Time Frame: one week after initial treatment ]
Same as current
Complete list of historical versions of study NCT00674232 on ClinicalTrials.gov Archive Site
  • side effects [ Time Frame: measured at follow up visit one week after initial treatment ] [ Designated as safety issue: No ]
  • acceptability [ Time Frame: measured at follow up visit one week after initial treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
Misoprostol for Treatment of Incomplete Abortion

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Incomplete Abortion
  • Drug: 600 mcg misoprostol
    single dose of misoprostol taken orally
    Other Name: Cytotec
  • Procedure: Surgical treatment
    Either dilation and curettage or manual vacuum aspiration, as per local protocol
    Other Name: D&C, MVA
  • Experimental: Misoprostol
    Group 1 randomized to take single dose of 600 mcg oral misoprostol
    Intervention: Drug: 600 mcg misoprostol
  • Surgical treatment
    Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)
    Intervention: Procedure: Surgical treatment
Montesinos R, Durocher J, León W, Arellano M, Peña M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. Epub 2011 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
October 2007
Not Provided

Inclusion Criteria:

  • past or present history of vaginal bleeding during pregnancy
  • open cervical os
  • evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
  • surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
  • generally in good health
  • woman lives or works within one hour of study site
  • woman willing to provide contact information for follow up purposes
  • informed consent given

Exclusion Criteria:

  • contraindications to study drug
  • uterine size larger than 12 weeks LMP
  • signs of severe infection
Female
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Ecuador,   Venezuela
 
NCT00674232
2.2.0
No
Dr. Beverly Winikoff, Gynuity Health Projects
Gynuity Health Projects
Not Provided
Study Director: Melanie Peña, MPH, MA Gynuity Health Projects
Study Director: Jill Durocher Gynuity Health Projects
Gynuity Health Projects
May 2008

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