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Trial record 16 of 638 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)
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transvaginal Digoxin Transabdominal Digoxin
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Transvaginal Digoxin Transabdominal Digoxin Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
26.8  (6.7) 26.6  (6.1) 26.7  (6.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
30
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 30 participants 30 participants 60 participants
21.5  (1.2) 21.4  (1.6) 21.4  (1.4)
Parity  
Mean (Standard Deviation)
Unit of measure:  Births
Number Analyzed 30 participants 30 participants 60 participants
0.8  (0.8) 0.87  (1.2) 0.83  (1.0)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters squared
Number Analyzed 30 participants 30 participants 60 participants
27.4  (5.0) 26.7  (4.8) 27.1  (4.8)
1.Primary Outcome
Title Patient Discomfort With Digoxin Injection (Pain Score)
Hide Description Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection)
Time Frame At time of study (immediate)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transvaginal Digoxin Transabdominal Digoxin
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.21  (1.33) 1.88  (1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transvaginal Digoxin, Transabdominal Digoxin
Comments No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transvaginal Digoxin Transabdominal Digoxin
Hide Arm/Group Description

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 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.

All-Cause Mortality
Transvaginal Digoxin Transabdominal Digoxin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transvaginal Digoxin Transabdominal Digoxin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Transvaginal Digoxin Transabdominal Digoxin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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.
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
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