Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00674232
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : May 7, 2008
Information provided by:
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Incomplete Abortion Drug: 600 mcg misoprostol Procedure: Surgical treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Misoprostol for Treatment of Incomplete Abortion
Study Start Date : May 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Misoprostol
Group 1 randomized to take single dose of 600 mcg oral misoprostol
Drug: 600 mcg misoprostol
single dose of misoprostol taken orally
Other Name: Cytotec

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
Other Name: D&C, MVA

Primary Outcome Measures :
  1. 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 :
  1. side effects [ Time Frame: measured at follow up visit one week after initial treatment ]
  2. acceptability [ Time Frame: measured at follow up visit one week after initial treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00674232

Layout table for location information
Hospital del Dia, CEMOPLAF
Quito, Ecuador
Hospital Gineco-obstetrico Isidro Ayora
Quito, Ecuador
Hospital Maternidad Concepcion Palacios
Caracas, Venezuela
Sponsors and Collaborators
Gynuity Health Projects
Layout table for investigator information
Study Director: Melanie Peña, MPH, MA Gynuity Health Projects
Study Director: Jill Durocher Gynuity Health Projects
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Beverly Winikoff, Gynuity Health Projects Identifier: NCT00674232    
Other Study ID Numbers: 2.2.0
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008
Keywords provided by Gynuity Health Projects:
incomplete abortion
spontaneous miscarriage
Additional relevant MeSH terms:
Layout table for MeSH terms
Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents