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

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: NCT00466999
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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 or disease Intervention/treatment Phase
Incomplete Abortion Drug: misoprostol Procedure: surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Study Start Date : February 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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): NCT00466999

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Burkina Faso
Dandé District Hospital/Ziniaré District Hospital
Dande/Ziniare, Burkina Faso
El-Galaa Teaching Hospital
Cairo, Egypt
Shatby Maternity Hospital/Alexandria University
Shatby, Alexandria, Egypt
Cheikh Zayed Hospital
Nouakchott, Mauritania
Maternite Issaka Gazobi
Niamey, Niger
Centre de Sante Le Roi Baudouin
Guediawaye, Senegal
Sponsors and Collaborators
Gynuity Health Projects
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects Identifier: NCT00466999    
Other Study ID Numbers: 2.2.2
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012
Keywords provided by Gynuity Health Projects:
incomplete abortion
Additional relevant MeSH terms:
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Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents