Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: 600 mcg misoprostol
  • single dose of misoprostol taken orally
• Procedure: Surgical treatment
  • Either dilation and curettage or manual vacuum aspiration, as per local protocol

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Misoprostol
  • Group 1 randomized to take single dose of 600 mcg oral misoprostol
• Other: Surgical treatment
  • Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)

Primary Measures

• 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
    

Secondary Measures

• side effects
  • Time Frame: measured at follow up visit one week after initial treatment
    Safety Issue?: No
• acceptability
  • Time Frame: measured at follow up visit one week after initial treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 14 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Melanie Peña, MPH, MA Study Director Gynuity Health Projects  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674232

Study ID Number: 2.2.0

ClinicalTrials.gov Identifier: NCT00674232

Health Authority: Ecuador: Hospital Gineco-obstetrico Isidro Ayora