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Completed

NCT Number: NCT01047748

A Trial of Digoxin Before Second-Trimester Abortion

The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Los Angeles - Bixby Health Center

Los Angeles, California, 90033, United States

About this study

Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D&E. In 2006, 144,000 D&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.

The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 18 years old
  • English or Spanish speaking
  • be able to give informed consent
  • documented fetal cardiac activity.

Exclusion criteria

  • significant medical illness or cardiovascular disease
  • current use of cardiac or antihypertensive medications
  • cardiac arrhythmia on preoperative EKG
  • multiple gestation
  • morbid obesity (BMI greater than 40)
  • known digoxin allergy

Treatment and study plan

intra-fetal digoxin injection

Drug

Single transabdominal injection of digoxin 1 mg into the fetus

Other names: Lanoxin

intra-amniotic digoxin injection

Drug

Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Other names: Lanoxin

Primary outcomes

  1. difference in fetal asystole rates between groups

    Time frame: one day

Secondary outcomes

  1. digoxin-related side effects

    Time frame: one day

  2. differences in surgical procedure between groups

    Time frame: one day

  3. subject satisfaction

    Time frame: one day

  4. serum digoxin levels in study subgroup

    Time frame: one day

Sponsors and collaborators

Lead sponsor

White, Katharine O'Connell, M.D., M.P.H.

Indiv

Collaborators

  • Society of Family Planning

Registry information

Official study title

A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2010
Registry last updated
May 1, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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