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

NCT03136068 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Digoxin RCT
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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.

Conditions

Abortion

Outcome Measures

Primary Outcomes (1)

• Procedure Duration

  First instrument into uterus until procedure complete

  Beginning to end of procedure (between 5 minutes and 1 hour)

Secondary Outcomes (4)

• Total Procedure Duration

  done on Day 2 during the procedure

• Measured Blood Loss

  Day 2, during the procedure

• Number of Patients With Reported Fetal Death Prior to Procedure

  Day 2, before procedure

• Complications

  Day 2

Study Arms (2)

Digoxin

EXPERIMENTAL

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

Drug: Digoxin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Digoxin DRUG

Trans-abdominal injection

Digoxin

Placebo DRUG

Trans-abdominal injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weeks 0 days-24 weeks 0 days gestation
• English or Spanish speaking
• years or older

You may not qualify if:

• Under 18
• Contraindications to digoxin

Sponsors & Collaborators

• University of California, San Francisco: lead
• FPA Women's Health: collaborator
• Society of Family Planning: collaborator
• Oregon Health and Science University: collaborator

Study Sites (3)

FPA Women's Health

Long Beach, California, 90806, United States

Location

SFGH Women's Options Center

San Francisco, California, 94110, United States

Location

Lovejoy Surgicenter

Portland, Oregon, 97210, United States

Location

MeSH Terms

Interventions

Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: UCSF

abby.sokoloff@ucsf.edu

414-206-8715

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: May 2, 2017
• Study Start: February 23, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Locations

US (3)