Early intervention with recombinant factor VIIa in severe postpartum hemorrhage: a retrospective observational study for evaluation of safety and efficacy of recombinant activated factor VII

Background: Postpartum hemorrhage (PPH) is a critical obstetric emergency and leading cause of maternal death worldwide and in India. Despite the availability of several measures to treat PPH, maternal mortality from severe PPH remains high, highlighting the unmet need in the management of PPH. One promising development is the use of recombinant activated factor VII (rFVIIa), which has been recently approved for treatment of severe PPH in India. Methods: This retrospective observational study compared the requirement of blood products, requirement of invasive procedures, and blood loss before and after rFVIIa administration in patients of severe PPH from two tertiary care centres in Bihar. rFVIIa was given when there was a persistent bleeding (blood loss>1000 ml) post-sequential uterotonics administration. Results: Only one of 47 patients with severe PPH required an invasive procedure after receiving rFVIIa; the remaining 46 responded without needing further surgical intervention. rFVIIa administration resulted in a significant reduction in blood loss, from 1215 ml pre-administration to only 219 ml post-administration (p<0.001). rFVIIa administration also resulted in a significant reduction in requirement of blood products, from 3.67 units pre-administration to only 1.44 units post-administration (n=34) (p<0.0001). No Thromboembolic events were reported in 30 days of follow-up. Conclusions: The study demonstrated that early use of rFVIIa in patients with severe PPH significantly reduced blood loss, blood product requirements, and the need for invasive procedures to control bleeding. When administered early in the management of severe PPH, rFVIIa offers a rapid, non-invasive, lifesaving, and fertility-preserving treatment option.