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

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: NCT01011634
Recruitment Status : Terminated (7% enrollment. Study terminated after a small number of recruited patients)
First Posted : November 11, 2009
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Undesired Intrauterine Pregnancy
First Trimester Pregnancy
Intervention: Drug: Intravenous moderate sedation versus oral medication

  Participant Flow

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
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Reporting Groups
Moderate Sedation No text entered.
Oral Medication No text entered.

Participant Flow:   Overall Study
    Moderate Sedation   Oral Medication
STARTED   9   9 
COMPLETED   9   8 

  Baseline Characteristics

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

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

  Outcome Measures

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

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

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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: Karen Meckstroth, MD
Organization: UCSF
phone: 415 206-8713

Responsible Party: University of California, San Francisco Identifier: NCT01011634     History of Changes
Other Study ID Numbers: H10873-28990-01
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: February 24, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 16, 2013