A Trial of Digoxin Before Second-Trimester Abortion

Study Overview
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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.

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.

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

Conditions
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Induced Abortion

Intervention / Treatment
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* Drug: intra-fetal digoxin injection
* Drug: intra-amniotic digoxin injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intra-fetal injection<br>Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion | Drug: intra-fetal digoxin injection<br>* Single transabdominal injection of digoxin 1 mg into the fetus<br>* Other names: Lanoxin;|
| Active Comparator: intra-amniotic injection<br>Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion | Drug: intra-amniotic digoxin injection<br>* Single transabdominal injection of digoxin 1 mg into the amniotic fluid<br>* Other names: Lanoxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in fetal asystole rates between groups |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| digoxin-related side effects |  | one day | 
| differences in surgical procedure between groups |  | one day | 
| subject satisfaction |  | one day | 
| serum digoxin levels in study subgroup |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abortion