Clinical Use and Outcome of NovoSeven® Treatment in Severe Postpartum Haemorrhage - Experiences From an Observational Multi-country (UK, DK, FR, NL) Retrospective Cohort Study

This is a retrospective non-interventional cohort study of women with sPPH who were treated with NovoSeven® or other standard of care. The analyses will be done utilising data that were collected for other purposes in four countries. The data include four previously established cohorts from the UK, France, Denmark and The Netherlands. In short, these population-based studies collected data, using enhanced systems, from the medical records of the women who met the case definition for each of the respective studies. Data are available from approximately 1260 (Netherlands, 39 exposed to NovoSeven®), 1655 (France, 18 exposed to NovoSeven®), 245 (DK, 28 exposed to NovoSeven®) and 162 (UK, 13 exposed to NovoSeven®) patients with persistent PPH.

Information regarding patient characteristics, concomitant treatment and outcomes in PPH women treated with NovoSeven® is limited in many countries. The current study will therefore include a description of women with PPH treated with NovoSeven®, or standard of care in each of the four cohorts. This will also include an assessment of the comparability of the cohorts and the overall rate of clinical outcomes in the study population. To aid in this assessment propensity scores will be calculated and used to match the women with an event of sPPH treated with NovoSeven® and those that are not.

The UK and Danish datasets were national and the datasets from Netherlands, and France were from multiple regions. The TeMpOH-1 study in the Netherlands collected data from 75% of national births. The EPIMOMS study in France collected data from six regions: Alsace, Lorraine, Auvergne, Rhone-Alpes, Ile-de-France and Basse-Normandie and these regions represented 18% of national births.

Data come from the below described cohorts.

Denmark: The Danish data were identified and collected using the Danish Medical Birth Registry (DMBR) and the Danish Trans-fusion Database (DTD). During the period 2001-2009, women who had a birth identified in the DMBR and had transfused 10 or more units of red blood cells (RBC) within 24 hours identified from DTD were included in study. The DMBR collects information on all births in Denmark and this includes clinical and demographic data from each birth. The DTD is a national database and contains information of the quantity and type of blood products transfused and the time of each transfusion. Additional data were extracted from the patient charts (Study II in the PhD thesis(PubMed ID 29510809)).