A Trial of Digoxin Before Second-Trimester Abortion

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