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RCT of intra-fetal vs. intra-amniotic digoxin feticide

Katharine O’Connell, Columbia University, 2008
See also executive summary.

Project abstract

Of the 1.2 million pregnancy terminations each year in the United States, approximately 4% occur at gestational ages 18 weeks or greater. Over 80% of these procedures are performed surgically via dilation and evacuation.

In 2007, the federal abortion ban that affects abortion in the second trimester was upheld by the Supreme Court. Since then, a greater number of providers are performing preoperative feticide via intra-amniotic or intrafetal digoxin injection.

Little is known, however, about the safety and relative effectiveness of the different feticidal techniques. We propose a randomized clinical trial of intra-amniotic vs. intrafetal digoxin (n = 270) to evaluate the immediate and peri-operative effects of digoxin feticide, in terms of patient safety, effectiveness of achieving fetal demise, and procedure ease.

Our study will be conducted at a single private abortion clinic in New York City. A subset of study participants (n = 40) will have serial digoxin levels drawn and continuous cardiac monitoring for twenty-four hours following digoxin administration prior to the abortion.

The primary outcome is feticide rates between the two injection techniques. The secondary outcomes include subject side effects, injection complications, operative time, blood loss, and subject satisfaction. Data collected in this study may be used to develop standards for digoxin-induced feticide at varying gestational ages.

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