Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00466999
First received: April 25, 2007
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.


Condition Intervention
Incomplete Abortion
Drug: misoprostol
Procedure: surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: February 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery
standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
Procedure: surgery
standard surgical treatment (dilation and curettage or manual vacuum aspiration)
Active Comparator: misoprostol
400 mcg misoprostol
Drug: misoprostol
single dose of 400 mcg misoprostol administered sublingually

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Uterine size no larger than 12 weeks LMP at time of presentation for care.
  • Past or present history of vaginal bleeding during pregnancy.
  • Open cervical os.
  • If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • General good health.
  • Willing to provide contact information for purposes of follow-up.
  • Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion Criteria:

  • Contraindications to study drug
  • Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • Hemodynamic disturbances (pulse >110/min and systolic bp <100)
  • Have an IUD in place; (the IUD may be removed making the woman eligible)
  • Suspected ectopic pregnancy
  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: NCT00466999

Locations
Burkina Faso
Dandé District Hospital/Ziniaré District Hospital
Dande/Ziniare, Burkina Faso
Egypt
El-Galaa Teaching Hospital
Cairo, Egypt
Shatby Maternity Hospital/Alexandria University
Shatby, Alexandria, Egypt
Mauritania
Cheikh Zayed Hospital
Nouakchott, Mauritania
Niger
Maternite Issaka Gazobi
Niamey, Niger
Senegal
Centre de Sante Le Roi Baudouin
Guediawaye, Senegal
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Study Director: Ayisha Diop, MPH 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: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00466999     History of Changes
Other Study ID Numbers: 2.2.2
Study First Received: April 25, 2007
Last Updated: March 28, 2012
Health Authority: Egypt: Local Ethical Committee
Mauritania: Allendale Investigational Review Board
Niger: Local Ethical Committee
Senegal: Local Ethical Committee
Burkina Faso: Local Ethical Committee

Keywords provided by Gynuity Health Projects:
misoprostol
incomplete abortion
PAC

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

ClinicalTrials.gov processed this record on October 21, 2014