The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
272
Single transabdominal injection of digoxin 1 mg into the fetus
Single transabdominal injection of digoxin 1 mg into the amniotic fluid
Planned Parenthood Los Angeles - Bixby Health Center
Los Angeles, California, United States
difference in fetal asystole rates between groups
Time frame: one day
digoxin-related side effects
Time frame: one day
differences in surgical procedure between groups
Time frame: one day
subject satisfaction
Time frame: one day
serum digoxin levels in study subgroup
Time frame: one day
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