A Trial of Digoxin Before Second-Trimester Abortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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intra-fetal injection

Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion

Group Type ACTIVE_COMPARATOR

intra-fetal digoxin injection

Intervention Type DRUG

Single transabdominal injection of digoxin 1 mg into the fetus

intra-amniotic injection

Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion

Group Type ACTIVE_COMPARATOR

intra-amniotic digoxin injection

Intervention Type DRUG

Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Interventions

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intra-fetal digoxin injection

Single transabdominal injection of digoxin 1 mg into the fetus

Intervention Type DRUG

intra-amniotic digoxin injection

Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Intervention Type DRUG

Other Intervention Names

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Lanoxin Lanoxin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No