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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.
 
ClinicalTrials.gov Identifier: NCT01939457
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date September 11, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
complete abortion [ Time Frame: 1 year ]
number of complete abortion with misoprostol treatment alone
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 400mcg Sublingual Misoprostol as First Line Treatment
Official Title  ICMJE Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Incomplete Abortion
Intervention  ICMJE Drug: Misoprostol
Study Arms  ICMJE Experimental: misoprostol
400 mcg misoprostol sublingually
Intervention: Drug: Misoprostol
Publications * Gaye A, Diop A, Shochet T, Winikoff B. Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion. Int J Gynaecol Obstet. 2014 Sep;126(3):223-6. doi: 10.1016/j.ijgo.2014.03.028. Epub 2014 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2013)
641
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939457
Other Study ID Numbers  ICMJE 2.2.4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beverly Winikoff, MD MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP