Phase 4 N=178 Randomized Quadruple-blind Other

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

Abortion

Bottom Line

View on ClinicalTrials.gov: NCT03136068 ↗

Enrolled (actual)

178

Serious AEs

0.6%

Results posted

Oct 2019

Primary outcome: Primary: Procedure Duration — 6.8; 7.2 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Digoxin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedure Duration	6.8; 7.2	—
SECONDARY Total Procedure Duration	9.7; 8.3	—
SECONDARY Measured Blood Loss	417; 363	—
SECONDARY Number of Patients With Reported Fetal Death Prior to Procedure	68; 6	—
SECONDARY Complications	8; 4	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03136068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.