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

Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136068
• Other study ID #: Digoxin RCT
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion

Intervention

Drug:
• Digoxin
Trans-abdominal injection
• Placebo
Trans-abdominal injection

Locations

Country	Name	City	State
United States	FPA Women's Health	Long Beach	California
United States	Lovejoy Surgicenter	Portland	Oregon
United States	SFGH Women's Options Center	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	FPA Women’s Health, Oregon Health and Science University, Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Duration	First instrument into uterus until procedure complete	Beginning to end of procedure (between 5 minutes and 1 hour)
Secondary	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
Secondary	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
Secondary	Number of Patients With Reported Fetal Death Prior to Procedure	number of patients who had fetal death measured by ultrasound	Day 2, before procedure
Secondary	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