Recombinant Factor VIIa in the Management of Postpartum Bleeds: An Audit of Clinical Use

Abstract

ABSTRACT

Massive postpartum bleeding remains a major cause of maternal morbidity and death. An estimated 90% of such deaths might be preventable. This study examined the efficacy of recombinant factor VIIa (rFVIIa), developed to treat hemophilic bleeding, in 25 women with severe or life-threatening postpartum bleeding whose case histories were submitted by 14 physicians from five countries.

Eight of the patients had disseminated intravascular coagulation. The patients had a median age of 30 years. Hemorrhage followed vaginal delivery in six cases; cesarean delivery in six; and hysterectomy in four. Eight women had cesarean section followed by hysterectomy, and one had hysterectomy following vacuum extraction. Six patients underwent internal iliac artery ligation. Numerous patients were receiving anticoagulant or antifibrinolytic treatment at the time rFVIIa was administered. Five of the 25 patients received two doses. The median total dose was 2.4 mg; the dose did not clearly correlate with the severity of bleeding.

Bleeding ceased after rFVIIa administration in 18 cases (72%) and decreased in six others. In only one instance did bleeding increase. The speed of response was not obviously related to the type of procedure performed, the severity of bleeding, or the dose of rFVIIa. Most patients still required replacement therapy in the first 24 hours after rFVIIa treatment, but much less than before. The median number of blood product units needed was halved. In addition, the median amount of crystalloids/colloids administered decreased markedly. No adverse effects were directly related to treatment with rFVIIa.

Experience with these patients—the largest group to receive rFVIIa in an attempt to control obstetrical bleeding—suggests that this agent may prove to be an effective and safe adjunctive means of controlling postpartum hemorrhage.