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Trial record 16 of 626 for:    transvaginal

Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

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ClinicalTrials.gov Identifier: NCT02277249
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : October 19, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Abortion, Induced
Interventions: Drug: Digoxin (transvaginal administration)
Drug: Digoxin (transabdominal administration)

  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
No text entered.

Reporting Groups
  Description
Transvaginal Digoxin

Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion

Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.

Transabdominal Digoxin

Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.


Participant Flow:   Overall Study
    Transvaginal Digoxin   Transabdominal Digoxin
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Transvaginal Digoxin

Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion

Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.

Transabdominal Digoxin

Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.

Total Total of all reporting groups

Baseline Measures
   Transvaginal Digoxin   Transabdominal Digoxin   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.8  (6.7)   26.6  (6.1)   26.7  (6.4) 
Gender 
[Units: Participants]
Count of Participants
     
Female      30 100.0%      30 100.0%      60 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Gestational Age 
[Units: Weeks]
Mean (Standard Deviation)
 21.5  (1.2)   21.4  (1.6)   21.4  (1.4) 
Parity 
[Units: Births]
Mean (Standard Deviation)
 0.8  (0.8)   0.87  (1.2)   0.83  (1.0) 
Body Mass Index 
[Units: Kilograms/meters squared]
Mean (Standard Deviation)
 27.4  (5.0)   26.7  (4.8)   27.1  (4.8) 


  Outcome Measures

1.  Primary:   Patient Discomfort With Digoxin Injection (Pain Score)   [ Time Frame: At time of study (immediate) ]


  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
There was crossover between treatment arms (4 subjects in the transvaginal group received transabdominal digoxin). This study is limited by its small sample size and attendant statistical power.


  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: Clinical Instructor - Department of Obstetrics and Gynecology
Organization: University of California, Los Angeles
phone: 3107942257
e-mail: priyabatra@mednet.ucla.edu



Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02277249     History of Changes
Other Study ID Numbers: IRB#12-001241
First Submitted: October 21, 2014
First Posted: October 28, 2014
Results First Submitted: February 8, 2016
Results First Posted: October 19, 2016
Last Update Posted: January 13, 2017