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MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00468299
First received: May 1, 2007
Last updated: June 23, 2011
Last verified: June 2011
Results First Received: April 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Early Pregnancy Failure
Miscarriage
Fetal Demise
Anembryonic Pregnancy
Interventions: Drug: Misoprostol and placebo
Drug: Mifepristone and misoprostol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally

Participant Flow:   Overall Study
    Misoprostol and Placebo     Mifepristone and Misoprostol  
STARTED     9     8  
COMPLETED     9     7  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
Total Total of all reporting groups

Baseline Measures
    Misoprostol and Placebo     Mifepristone and Misoprostol     Total  
Number of Participants  
[units: participants]
  9     8     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 4     29  ± 4     28  ± 3  
Gender  
[units: participants]
     
Female     9     8     17  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     8     17  



  Outcome Measures
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1.  Primary:   Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.   [ Time Frame: 24-48 hrs ]

2.  Secondary:   Complete Abortion at One Week   [ Time Frame: 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated because of poor enrollment. Few eligible women were referred.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sarah Betstadt
Organization: University of Rochester
phone: 585-276-5368
e-mail: sarah_betstadt@urmc.rochester.edu


Publications:


Responsible Party: Sarah Betstadt, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00468299     History of Changes
Other Study ID Numbers: H-25999
Study First Received: May 1, 2007
Results First Received: April 12, 2011
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board