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A Trial of Digoxin Before Second-Trimester Abortion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01047748
Enrollment
272
Registered
2010-01-13
Start date
2011-01-31
Completion date
2013-01-31
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Abortion

Keywords

abortion

Brief summary

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

Detailed 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.

Interventions

DRUGintra-fetal digoxin injection

Single transabdominal injection of digoxin 1 mg into the fetus

DRUGintra-amniotic digoxin injection

Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Sponsors

Society of Family Planning
CollaboratorOTHER
White, Katharine O'Connell, M.D., M.P.H.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
difference in fetal asystole rates between groupsone day

Secondary

MeasureTime frame
digoxin-related side effectsone day
differences in surgical procedure between groupsone day
subject satisfactionone day
serum digoxin levels in study subgroupone day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026