A Trial of Digoxin Before Second-Trimester Abortion

Not Applicable

Completed

• Conditions: Induced Abortion
• Interventions: Drug: intra-fetal digoxin injection; Drug: intra-amniotic digoxin injection

• Registration Number: NCT01047748
• Lead Sponsor: White, Katharine O'Connell, M.D., M.P.H.

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.

Study Timeline

• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
difference in fetal asystole rates between groups	one day

Secondary Outcome Measures

Name	Time	Method
subject satisfaction	one day
serum digoxin levels in study subgroup	one day
digoxin-related side effects	one day
differences in surgical procedure between groups	one day

Trial Locations

Locations (1)

Planned Parenthood Los Angeles - Bixby Health Center; 🇺🇸 Los Angeles, California, United States