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

Phase 4

Completed

• Conditions: Abortion
• Interventions: Drug: Digoxin; Drug: Placebo

• Registration Number: NCT03136068
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-06
• Study Start: 2017-02-23
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-10
• Results First Submitted: 2019-10-09
• Results First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Results First Posted: 2019-10-30
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digoxin	Digoxin	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Placebo	Placebo	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume

Primary Outcome Measures

Name	Time	Method
Procedure Duration	Beginning to end of procedure (between 5 minutes and 1 hour)	First instrument into uterus until procedure complete

Secondary Outcome Measures

Name	Time	Method
Total Procedure Duration	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
Measured Blood Loss	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
Complications	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
Number of Patients With Reported Fetal Death Prior to Procedure	Day 2, before procedure	number of patients who had fetal death measured by ultrasound

Trial Locations

Locations (3)

Lovejoy Surgicenter; 🇺🇸 Portland, Oregon, United States

FPA Women's Health; 🇺🇸 Long Beach, California, United States

SFGH Women's Options Center; 🇺🇸 San Francisco, California, United States