Efficacy of Prophylactic Intravenous Fibrinogen in Reducing Bleeding in Cesarean Section, a Randomized Controlled Trial

Background & Objective: Postpartum hemorrhage is the most common cause of maternal morbidity and mortality, which can occur unexpectedly without warning, and without any underlying causes. We hypothesized that administering fibrinogen concentrate to cesarean section patients before surgery would reduce perioperative blood loss.Materials & Methods: In this double-blind randomized controlled parallel group study, a single dosage of fibrinogen concentrate or a placebo was given to ۲۶۰ cesarean section patients at random (by G*Power software, Heinrich-Heine-Universität Düsseldorf, Germany) in a university-affiliated general hospital between November ۱۱, ۲۰۲۲, to January ۸, ۲۰۲۳. Individuals in the fibrinogen group received a dose of one gram of fibrinogen concentrate and those in the placebo group received normal saline solution with the same volume in the placebo group. Total blood loss was the primary outcome of this study.Results: A total of ۲۸۰ cases were screened and ۲۶۰ were randomized. With a P-value of ۰.۰۰۱, the median (IQR) volume of bleeding in the fibrinogen group was ۶۶۰ (۳۴۱.۲۵) mL, as opposed to ۷۹۰ (۴۷۵.۰۰) mL in the placebo group. Comparatively, only ۱۰ (۷.۷%) of the fibrinogen group and ۲۶ (۲۰%) of the placebo group required blood transfusions (P=۰.۰۰۶). No adverse event related to fibrinogen was reported. Conclusion: Empiric treatment with fibrinogen concentrate results in reduced blood loss.