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

Sponsored by:	Gynuity Health Projects
Information provided by:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00674232

Purpose

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.

Condition	Intervention
Incomplete Abortion	Drug: 600 mcg misoprostol Procedure: Surgical treatment

Drug Information available for: Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Misoprostol for Treatment of Incomplete Abortion

Further study details as provided by Gynuity Health Projects:

Primary Outcome 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 Outcome Measures:

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 ]

Enrollment:	311
Study Start Date:	May 2006
Study Completion Date:	October 2007

Arms	Assigned Interventions
Misoprostol: Experimental Group 1 randomized to take single dose of 600 mcg oral misoprostol	Drug: 600 mcg misoprostol single dose of misoprostol taken orally
Surgical treatment Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)	Procedure: Surgical treatment Either dilation and curettage or manual vacuum aspiration, as per local protocol

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674232

Locations

Ecuador
Hospital Gineco-obstetrico Isidro Ayora
Quito, Ecuador
Hospital del Dia, CEMOPLAF
Quito, Ecuador
Venezuela
Hospital Maternidad Concepcion Palacios
Caracas, Venezuela

Sponsors and Collaborators

Gynuity Health Projects

Investigators

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

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Gynuity Health Projects ( Dr. Beverly Winikoff )
Study ID Numbers:	2.2.0
Study First Received:	April 28, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00674232
Health Authority:	Ecuador: Hospital Gineco-obstetrico Isidro Ayora; Venezuela: Hospital Maternidad Concepcion Palacios

Keywords provided by Gynuity Health Projects:

incomplete abortion
spontaneous miscarriage

Study placed in the following topic categories:

Pregnancy Complications
Misoprostol
Abortion, Spontaneous
Abortion, Incomplete

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009