Planned Parenthood Los Angeles - Bixby Health Center
Los Angeles, California, 90033, United States
NCT Number: NCT01047748
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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Notify Me18 year–55 year
Female
Interventional
Not applicable
Los Angeles, California, 90033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single transabdominal injection of digoxin 1 mg into the fetus
Other names: Lanoxin
Single transabdominal injection of digoxin 1 mg into the amniotic fluid
Other names: Lanoxin
Time frame: one day
Time frame: one day
Time frame: one day
Time frame: one day
Time frame: one day
White, Katharine O'Connell, M.D., M.P.H.
Indiv
A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination
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