Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
NCT ID: NCT03136068
Last Updated: 2019-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
178 participants
INTERVENTIONAL
2017-02-23
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Digoxin
Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Digoxin
Trans-abdominal injection
Placebo
Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Placebo
Trans-abdominal injection
Interventions
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Digoxin
Trans-abdominal injection
Placebo
Trans-abdominal injection
Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking
* 18 years or older
Exclusion Criteria
* Contraindications to digoxin
18 Years
FEMALE
Yes
Sponsors
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FPA Women's Health
UNKNOWN
Society of Family Planning
OTHER
Oregon Health and Science University
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Jennifer Kerns, MD, MS, MPH
Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences
Locations
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FPA Women's Health
Long Beach, California, United States
SFGH Women's Options Center
San Francisco, California, United States
Lovejoy Surgicenter
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Digoxin RCT
Identifier Type: -
Identifier Source: org_study_id
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