POC test for Monitoring Post Partum Hemorrhage
Post-Partum Hemorrhage (PPH) remains the leading cause of maternal mortality worldwide, responsible for about one quarter of maternal deaths. The World Health Organization (WHO) defines PPH as blood loss from the genital tract of 500 mL or more within 24 hours of birth, and severe PPH (SSPH) as 1,000 mL of blood loss, independently of the mode of delivery ¹. The more traditional definitions of PPH consider blood loss ≥ 500 mL following vaginal delivery and ≥ 1,000 mL following caesarean delivery². The prevalence of PPH and SPPH worldwide, is approximately 6% and 1.86% of all deliveries respectively, with significant differences between countries. The prevalence of PPH and SSPH is 9.38% and 5.49% respectively in Western Europe. The risk of maternal death from PPH is around 1 in 1,000 deliveries worldwide, and the rate of PPH is increasing in industrialized countries¹.
Fibrinogen, a critical factor for hemostasis involved in the architecture of the clot, is the first coagulation factor to decrease during major bleeding. During pregnancy, fibrinogen concentrations in blood increase, particularly from week 28 of gestation to delivery, to reach a concentration of 3.5 – 6.5 g/L i.e. nearly double that of non-pregnant women. In the obstetric population, the fibrinogen level in blood is an important predictor of the severity of PPH³. In their study, Charby et al. reported that a fibrinogen concentration below 2 g/L was predictive of severe PPH, with a positive predictive value of 100% (95% CI: 71–100)4 . There is increasing evidence of the role of fibrinogen as a target for the treatment of bleeding, especially in PPH. Cryoprecipitate and fibrinogen concentrates are preferable products for the treatment of hypofibrinogenemia. For trauma patients with a plasma fibrinogen level of less than 1.5 to 2.0 g/L, the European guidelines on management of major bleeding and coagulopathy following trauma: fourth edition, recommend an initial dose of fibrinogen concentrates of 3 to 4 g6. Further dosing should then be guided by laboratory assessment of the plasma fibrinogen level5.
PPH is a life-threatening condition for the mother and requires the early identification of bleeding and rapid management to stop the bleeding. While traditional measurements of fibrinogen (Clauss method) are time consuming, point-of-care (POC) testing of fibrinogen may provide real-time data that can be helpful in the clinical decision-making process in actively bleeding patients.
OVVI Diagnostics is developing a point-of-care test for fibrinogen quantification in blood, providing a lab-quality result within a few minutes to improve the management of PPH.
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