Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 178
- Locations
- 3
- Primary Endpoint
- Procedure Duration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •20 weeks 0 days-24 weeks 0 days gestation
- •English or Spanish speaking
- •18 years or older
Exclusion Criteria
- •Contraindications to digoxin
Arms & Interventions
Digoxin
Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Intervention: Digoxin (Drug)
Placebo
Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Procedure Duration
Time Frame: Beginning to end of procedure (between 5 minutes and 1 hour)
First instrument into uterus until procedure complete
Secondary Outcomes
- Total Procedure Duration(done on Day 2 during the procedure)
- Measured Blood Loss(Day 2, during the procedure)
- Complications(Day 2)
- Number of Patients With Reported Fetal Death Prior to Procedure(Day 2, before procedure)
Investigators
Jennifer Kerns, MD, MS, MPH
Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences
University of California, San Francisco