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Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

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.
 
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

Brief Summary:
Current practice for the provision of late second trimester abortion (dilation and evacuation, or D&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).

Condition or disease Intervention/treatment Phase
Abortion, Induced Drug: Digoxin (transvaginal administration) Drug: Digoxin (transabdominal administration) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference
Study Start Date : October 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Transvaginal digoxin
Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Drug: 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
Drug: 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.




Primary Outcome Measures :
  1. Patient Discomfort With Digoxin Injection (Pain Score) [ Time Frame: At time of study (immediate) ]
    Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Singleton viable gestation
  • Identifying as primarily English-speaking
  • Body mass index less than 40 kilograms/meters squared
  • Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site
  • No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02277249    
Other Study ID Numbers: IRB#12-001241
First Posted: October 28, 2014    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: January 13, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs