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Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation

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: NCT03136068
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborators:
FPA Women's Health
Society of Family Planning
Oregon Health and Science University
Information provided by (Responsible Party):
Jennifer Kerns, MD, MS, MPH, University of California, San Francisco

Brief Summary:
This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure time, if at all.

Condition or disease Intervention/treatment Phase
Abortion Drug: Digoxin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Experimental: Digoxin
Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Drug: Digoxin
Trans-abdominal injection

Placebo Comparator: Placebo
Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Drug: Placebo
Trans-abdominal injection




Primary Outcome Measures :
  1. Procedure Duration [ Time Frame: Beginning to end of procedure (between 5 minutes and 1 hour) ]
    First instrument into uterus until procedure complete


Secondary Outcome Measures :
  1. Total Procedure Duration [ Time Frame: done on Day 2 during the procedure ]
    Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything

  2. Measured Blood Loss [ Time Frame: Day 2, during the procedure ]
    measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood

  3. Number of Patients With Reported Fetal Death Prior to Procedure [ Time Frame: Day 2, before procedure ]
    number of patients who had fetal death measured by ultrasound

  4. Complications [ Time Frame: Day 2 ]
    hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting



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:

  • 20 weeks 0 days-24 weeks 0 days gestation
  • English or Spanish speaking
  • 18 years or older

Exclusion Criteria:

  • Under 18
  • Contraindications to digoxin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136068


Locations
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United States, California
FPA Women's Health
Long Beach, California, United States, 90806
SFGH Women's Options Center
San Francisco, California, United States, 94110
United States, Oregon
Lovejoy Surgicenter
Portland, Oregon, United States, 97210
Sponsors and Collaborators
University of California, San Francisco
FPA Women's Health
Society of Family Planning
Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Jennifer Kerns, MD, MS, MPH, University of California, San Francisco:
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Responsible Party: Jennifer Kerns, MD, MS, MPH, Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03136068    
Other Study ID Numbers: Digoxin RCT
First Posted: May 2, 2017    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs