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Effect of intracardiac potassium chloride for feticide before dilatation and evacuation on procedure duration and outcomes

Patricia Lohr, bpas, 2012

Project abstract

Administration of feticide prior to dilatation and evacuation (D&E) is purported to make surgery faster and safer by softening fetal tissues. One placebo-controlled randomised trial of intra-amniotic digoxin did not demonstrate a benefit in either procedure duration or complications when used before D&E at 20-24 weeks gestation.

Digoxin failed to cause fetal demise in 9% of cases in that trial and is known to take several hours before inducing demise even when it is successful. Intra-cardiac potassium chloride may be more effective because fetal demise is confirmed at administration, maximising the time for tissue softening.

This single-blind randomised trial will include 342 women eligible for D&E with feticide at three abortion facilities run by the British Pregnancy Advisory Service (bpas). Criteria for administration of feticide at bpas are: gestational age ≥22 weeks or gestational age ≥18 weeks gestation and age ≤18 years, body mass index ≥33, or history of ≥2 Caesarean deliveries.

Subjects will be assigned randomly to feticide with intra-cardiac potassium chloride 24±3 hours prior to evacuation or no feticide. All subjects will receive cervical preparation with Dilapan osmotic dilators inserted 24±3 hours before surgery with 400 mcg vaginal misoprostol administered 3 hours before evacuation.

The primary outcome is D&E duration. Secondary outcomes are side effects, immediate complications, blood loss, ease of procedure, and patient preferences. We will also determine whether selected patient characteristics or provider influenced outcomes. A sample size of 342 provides 80% power to detect a mean difference between groups of 1 minute, assuming a mean procedure duration of 10 minutes and a standard deviation of 3.3.

The study will be managed by bpas, an independent abortion provider in the United Kingdom which performs the majority of D&Es in this country. We expect that our findings will contribute to the delivery of evidence-based abortion care.

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