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Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions

This study has been terminated.
(7% enrollment. Study terminated after a small number of recruited patients)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01011634
First received: November 9, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
Results First Received: February 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Undesired Intrauterine Pregnancy
First Trimester Pregnancy
Intervention: Drug: Intravenous moderate sedation versus oral medication

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Moderate Sedation No text entered.
Oral Medication No text entered.

Participant Flow:   Overall Study
    Moderate Sedation     Oral Medication  
STARTED     9     9  
COMPLETED     9     8  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Reporting Groups
  Description
Moderate Sedation No text entered.
Oral Medication No text entered.
Total Total of all reporting groups

Baseline Measures
    Moderate Sedation     Oral Medication     Total  
Number of Participants  
[units: participants]
 		  9     9     18  
Age, Customized [1]
[units: participants]
 		     
>= 18 years old     9     9     18  
Gender  
[units: participants]
 		     
Female     9     9     18  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     9     9     18  
[1] no baseline measurement as study stopped for low enrollment



  Outcome Measures
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1.  Primary:   Pain Score Within 5 Mins After Procedure   [ Time Frame: within 5 mins after procedure ]
  Show Outcome Measure 1

2.  Secondary:   Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration   [ Time Frame: 30 min after procedure ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Karen Meckstroth, MD
Organization: UCSF
phone: 415 206-8713
e-mail: meckstrothk@obgyn.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01011634     History of Changes
Other Study ID Numbers: H10873-28990-01
Study First Received: November 9, 2009
Results First Received: February 24, 2013
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board