ROTEM in pregnancy in women with bleeding disorders
Research type
Research Study
Full title
A case-control study assessing the role of rotational thromboelastometry (ROTEM) in assessment of bleeding risk during pregnancy in women inherited bleeding disorders
IRAS ID
142817
Contact name
Rezan Kadir
Contact email
Sponsor organisation
Joint Research Office
Research summary
Women with IBD are at risk of both primary and secondary PPH. The risk is dependent on the mode of delivery, obstetric factors and coagulation. The risk of bleeding and factor levels correlate well in women with IBD such as haemophilia carriers and mild von Willebrand disease (VWD). However in women with IBD such as FXI, type 2 VWD and rare bleeding disorders there is no good correlation. Current practice and UK guidelines recommends maintaining factor levels >50 IU/dL during delivery to prevent primary PPH. Women with IBD and low factor levels are treated with factor concentrates to reduce the risk of bleeding at delivery.
Pregnancy is associated with a hypercoagulable state with an increase in most clotting factors, which leads to a normalisation of the factor deficiency in some IBD. The assumption is that the physiological rise in other coagulation factors during pregnancy may compensate for the single factor deficiency and a global hypercoagulable status is achieved. Relying on the single factor level may result in inappropriate assessment of the bleeding risk and increased use of factor concentrate, which carries the inherent risks of blood product treatment as well as cost.
ROTEM is a global test that assesses the overall haemostatic ability. We propose a case control study to compare ROTEM parameters in women with IBD with healthy controls. The changes in ROTEM parameters will be used to predict bleeding risk. This is useful to manage the bleeding risk and guide decisions regarding the need for factor concentrate in women with IBD.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
13/LO/1903
Date of REC Opinion
29 Jan 2014
REC opinion
Further Information Favourable Opinion