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A Trial of Digoxin Before Second-Trimester Abortion

W

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

Status

Completed

Conditions

Induced Abortion

Treatments

Drug: intra-amniotic digoxin injection
Drug: intra-fetal digoxin injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01047748
20082058

Details and patient eligibility

About

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

Full description

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.

Enrollment

272 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

272 participants in 2 patient groups

intra-fetal injection
Active Comparator group
Description:
Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion
Treatment:
Drug: intra-fetal digoxin injection
intra-amniotic injection
Active Comparator group
Description:
Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion
Treatment:
Drug: intra-amniotic digoxin injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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