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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Abortion

Treatments: Drug: Digoxin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03136068

Digoxin RCT

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups, including a placebo group

Digoxin

Experimental group

Description:

Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance

Treatment:

Drug: Digoxin

Placebo

Placebo Comparator group

Description:

Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume

Treatment:

Drug: Placebo