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

Primary Purpose

Abortion

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Digoxin
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abortion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • FPA Women's Health
  • SFGH Women's Options Center
  • Lovejoy Surgicenter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Digoxin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Procedure Duration
First instrument into uterus until procedure complete

Secondary Outcome Measures

Total Procedure Duration
Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything
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
Number of Patients With Reported Fetal Death Prior to Procedure
number of patients who had fetal death measured by ultrasound
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

Full Information

First Posted
February 6, 2017
Last Updated
October 9, 2019
Sponsor
University of California, San Francisco
Collaborators
FPA Women's Health, Society of Family Planning, Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03136068
Brief Title
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
FPA Women's Health, Society of Family Planning, Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digoxin
Arm Type
Experimental
Arm Description
Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Trans-abdominal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Trans-abdominal injection
Primary Outcome Measure Information:
Title
Procedure Duration
Description
First instrument into uterus until procedure complete
Time Frame
Beginning to end of procedure (between 5 minutes and 1 hour)
Secondary Outcome Measure Information:
Title
Total Procedure Duration
Description
Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything
Time Frame
done on Day 2 during the procedure
Title
Measured Blood Loss
Description
measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood
Time Frame
Day 2, during the procedure
Title
Number of Patients With Reported Fetal Death Prior to Procedure
Description
number of patients who had fetal death measured by ultrasound
Time Frame
Day 2, before procedure
Title
Complications
Description
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
Time Frame
Day 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
FPA Women's Health
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
SFGH Women's Options Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Lovejoy Surgicenter
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

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

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