Abstract
BackgroundAn antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries.Methods/designThis study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%.DiscussionAs an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.Trial registrationClinicalTrials.gov NCT03431805 (February 12, 2018).
Highlights
An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery
We propose to perform an adequately powered, multicenter, randomized, placebo-controlled trial to determine what effect, if any, systematic tranexamic acid administration after cesarean delivery has on PPH incidence
Data management Each investigator will be responsible for ensuring the accurate recording of the data, which will be completed by clinical research technicians (CRTs) throughout the trial, with Clinsight software
Summary
An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. A calculated estimated blood loss ≥1000 mL [calculated estimated blood loss = estimated blood volume × (preoperative hematocrit – postoperative hematocrit/preoperative hematocrit (where estimated blood volume = booking weight (kg) × 85)] defined the PPH incidence that was the primary outcome in their trial They chose this validated calculation as a quantitative objective measure to estimate blood loss [6, 7] because it is widely accepted that clinicians underestimate this loss [8, 9] and that gravimetric methods include liquor in addition to blood, which limits their accuracy, especially for cesareans [10]. This result is consistent with that of the French prospective study mentioned above, which estimated blood loss clinically [4]
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