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Completed

NCT Number: NCT03136068

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

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.

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Key information

Conditions

Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

FPA Women's Health, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digoxin

Drug

Trans-abdominal injection

Placebo

Drug

Trans-abdominal injection

Primary outcomes

  1. Procedure Duration

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

    First instrument into uterus until procedure complete

Secondary outcomes

  1. Total Procedure Duration

    Time frame: 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

  2. Measured Blood Loss

    Time frame: 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

  3. Number of Patients With Reported Fetal Death Prior to Procedure

    Time frame: Day 2, before procedure

    number of patients who had fetal death measured by ultrasound

  4. Complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • FPA Women's Health
  • Oregon Health and Science University
  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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