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

Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Abortion
• Intervention / Treatment: Drug: Digoxin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • FPA Women's Health
    • San Francisco, California, United States, 94110
      • SFGH Women's Options Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Lovejoy Surgicenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digoxin; Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance	Drug: Digoxin; Trans-abdominal injection
Placebo Comparator: Placebo; Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume	Drug: Placebo; Trans-abdominal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration	First instrument into uterus until procedure complete	Beginning to end of procedure (between 5 minutes and 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Procedure Duration	Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything	done on Day 2 during the procedure
Measured Blood Loss	measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood	Day 2, during the procedure
Number of Patients With Reported Fetal Death Prior to Procedure	number of patients who had fetal death measured by ultrasound	Day 2, before procedure
Complications	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	Day 2

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Oregon Health and Science University; Society of Family Planning; FPA Women's Health

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: Digoxin RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No