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

Tracking Information

First Received Date ^ICMJE

April 28, 2008

Last Updated Date

May 5, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00674232 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Misoprostol for Treatment of Incomplete Abortion

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Incomplete Abortion

Intervention ^ICMJE

Drug: 600 mcg misoprostol
Procedure: Surgical treatment

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

311

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

14 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ecuador, Venezuela

Administrative Information

NCT ID ^ICMJE

NCT00674232

Responsible Party

Dr. Beverly Winikoff, Gynuity Health Projects

Study ID Numbers ^ICMJE

2.2.0

Study Sponsor ^ICMJE

Gynuity Health Projects

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Melanie Peña, MPH, MA	Gynuity Health Projects
Study Director:	Jill Durocher	Gynuity Health Projects

Information Provided By

Gynuity Health Projects

Verification Date

May 2008

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