Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial

What this Trial Is About

This research focuses on postpartum hemorrhage (PPH), a major cause of maternal illness and death worldwide, defined as blood loss of 500 mL or more within 24 hours after delivery. The study aims to determine if early replenishment of coagulation factor XIII (FXIII) can reduce postpartum blood loss and related complications. Current treatments mainly focus on fibrinogen replacement, but evidence for its effectiveness is inconclusive, prompting investigation of FXIII's role based on previous studies showing its association with blood loss. Women who experience PPH with measured blood loss of at least 500 mL receive 1g of tranexamic acid intravenously as standard care. If bleeding continues and exceeds 700 mL, participants are randomly assigned to one of two groups: the intervention group receives FXIII (Fibrogammin®) intravenously at doses based on weight in addition to standard care, while the control group receives standard care alone. This is a nationwide, multi-center, open-label, randomized controlled trial conducted in perinatal centers across Switzerland. Participants will be monitored for blood loss during the first 24 hours after delivery as the primary outcome. Additional assessments include clinical outcomes of PPH at around 48 hours postpartum, changes in blood tests such as hemoglobin and platelet counts before delivery and at 48 hours, hospital costs, breastfeeding status at 6 to 9 weeks, and patient surveys shortly after hospital discharge. The study includes safety monitoring and follow-up during hospital stay and beyond, with participation lasting up to nine weeks after delivery.

SWIFT - SWIss Factor XIII Trial in PPH