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400mcg Sublingual Misoprostol as First Line 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: NCT01939457
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

Condition or disease Intervention/treatment Phase
Incomplete Abortion Drug: Misoprostol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal
Study Start Date : September 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: misoprostol
400 mcg misoprostol sublingually
Drug: Misoprostol

Primary Outcome Measures :
  1. complete abortion [ Time Frame: 1 year ]
    number of complete abortion with misoprostol treatment alone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • uterine size less than 12 weeks lmp
  • open cervical os
  • current or past vaginal bleeding
  • willing to provide contact information for follow-up
  • over 18 or with guardian consent

Exclusion Criteria:

  • suspicion of ectopic pregnancy
  • intrauterine device in place
  • bad general health (infection, anemia, shoc)

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): NCT01939457

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Guediawaye Health Center
Guediawaye, Senegal
Sponsors and Collaborators
Gynuity Health Projects
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Principal Investigator: Beverly Winikoff, MD MPH Gynuity Health Projects
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects Identifier: NCT01939457    
Other Study ID Numbers: 2.2.4
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
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