Effect of prophylactic tranexamic acid on bleeding outcomes in women undergoing dilation and evacuation
Abortion
Awarded 2021
Complex Family Planning Fellowship Research
Marit Pearlman Shapiro, MD, MPH
University of Hawaii
$14,967

Hemorrhage is the most common complication of dilation and evacuation (D&E). Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with D&E. We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation. Tranexamic acid has not been studied at the time of D&E so our objectives are to 1) determine whether tranexamic acid appears to confers a benefit and 2) estimate the degree of that benefit in order to properly calculate sample size for a definitive interventional study. Subjects presenting for D&E from 16 to 24 weeks gestation will be randomized to 1g IV tranexamic acid versus matching placebo. Our primary outcome is the rate at which providers perform interventions to control blood loss during D&E procedures, including bimanual massage, administration of medications (misoprostol, methergine, carboprost and oxytocin) and performing additional procedures (e.g. re-aspiration, uterine artery embolization, exploratory laparoscopy or laparotomy). Secondary outcomes include measured blood loss, rates of hemorrhage (blood loss above 500 mL), procedure length, and complication rates. Exclusion criteria include history of thromboembolic events or inability to provide written informed consent. Given that this is a pilot study, our primary analysis will be descriptive. We will also compare the need for interventions to control bleeding between treatment and control groups using a chi-square or Fisher’s exact test, and secondary outcomes will be compared using a student’s t-test. To demonstrate a reduction in interventions to control bleeding from 15% to 2% (80% power, two-sided alpha of 0.05), 156 participants are needed. The pilot study seeks to recruit 30% of the needed sample size, or 50 participants.

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