Intrafetal digoxin as an adjuvant for dilation and evacuation at 20 to 24 weeks’ gestation: A placebo-controlled, double-blinded randomized controlled trial
Awarded 2015
Large Research Grants
Jennifer Kerns, MD, MPH, MS
University of California, San Francisco

Inducing fetal demise before abortion in the later second trimester is a common practice despite its unproven utility. Digoxin is the most commonly used feticidal agent among family planning subspecialists, with intrafetal administration more effective at achieving fetal demise than the intra-amniotic route. Reasons for inducing fetal demise before abortion in the later second trimester include provider preference, patient preference, and concerns regarding the legal status of later dilation and evacuations. Many observational studies and one randomized controlled trial (RCT) have reported on the use of digoxin to induce fetal demise before abortion and these findings have helped clarify the pharmacokinetics, adverse effects, optimal dosages and routes of administration, and success with achieving demise. Only one study, an RCT, described the effect of digoxin before abortion on the dilation and evacuation procedure itself and found there was no difference in procedure duration between women randomized to digoxin versus placebo before dilation and evacuation at 20-23 weeks’ gestation. Some providers have questioned the generalizability of these findings, however, and continue to routinely use digoxin before abortion in the later second trimester. Given the lack of data supporting the routine use of digoxin to facilitate dilation and evacuation, we propose an RCT of the effect of intrafetal digoxin versus placebo on dilation and evacuation procedure duration. We also will measure complications and adverse events, provider rating of ease of procedure and patients’ symptoms. We have designed the study to address some of the concerns of generalizability from the Jackson et al. intra-amniotic digoxin RCT. The findings from our RCT should offer to offer a strong base of evidence informing the practice of routinely inducing fetal demise with digoxin before abortion in the later second trimester.

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