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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Misoprostol for Treatment of Incomplete Abortion

Resource links provided by NLM:


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
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

  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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Beverly Winikoff, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00674232     History of Changes
Other Study ID Numbers: 2.2.0
Study First Received: April 28, 2008
Last Updated: May 5, 2008
Health Authority: Ecuador: Hospital Gineco-obstetrico Isidro Ayora
Venezuela: Hospital Maternidad Concepcion Palacios

Keywords provided by Gynuity Health Projects:
incomplete abortion
spontaneous miscarriage

Additional relevant MeSH terms:
Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 24, 2014