Use of Activated Recombinant Factor VII for the Control of Post Partum Hemorrhage (PPH).

Objective: To evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa) in the control of PPH

Patients and Methods: All patients with massive PPH who failed medical and surgical treatment were eligible for the investigation. Massive PPH was defined as loss of > 1000 ml of blood within 24 h after delivery. Patients were considered for treatment with rFVIIa after failure of conventional measures such administration of myotonic agents including oxytocin, ergotamine, misoprostol and failure of other interventions aimed at controlling blood loss such as ligation of uterine and ovarian vessels, or ligation of internal iliac artery. The primary outcome measures were control of the bleeding episode and reduction in the number of administered blood products.

Results: A total of 16 patients with massive PPH were eligible for the current study. Vaginal and vacuum delivery was used in 6 patients while 10 patients underwent C-section. The mean dose of rFVIIa was 68 mcg/kg administered intravenously as a single bolus injection. Mean time of diagnosing PPH and administration was 5.5 hours (+/−2). The mean number of blood products used prior the administration of rFVIIa was 14 units RBC and 12 units of FFP. Cessation of blood loss was achieved in 14 patients within an average of 20 minutes after the administration of rFVIIa. The blood products utlilized after the administration of rFVIIa in these patients were 2 URBC and 2UFFP. The uterus was conserved in 7 patients who received rFVIIa prior to hysterectomy. While in 9 patients rFVIIa was administered after failure of hysterectomy to control blood loss. Of the 16 patients, 3 died because of multiorgan failure following severe blood loss. No adverse events including thromboembolic phenomena were observed.

Conclusion: Massive PPH is the most common cause of maternal mortality in developing countries. The use of rFVIIa in patients with massive PPH can achieve hemostasis with a single dose only. The administration of rFVIIa in patients with massive PPH may avoid the need for hysterectomy. There were no safety issues in the current study. Further trials should address the dose and timing of administration of rFVIIa in patients with massive PPH.