NN7711-4729 Clinical outcomes of NovoSeven® treatment in severe postpartum haemorrhage – a retrospective single-centre cohort study at the University Hospital of Bern

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Postpartum haemorrhage

Population studied

• Short description of the study population:
  Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care, respectively including data from four cohorts of sPPH patients during the period of January 2006-April 2016.; ; Inclusion criteria; For an eligible patient, all inclusion criteria must be answered “yes”.; 1. Females; 2. sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery; 3. Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  225

Study design details

• Main study objective:
  To compare the incidence of invasive procedures in women with an event of severe PostPartum Haemorrhage (sPPH) treated with NovoSeven® to the incidence of invasive procedures in women with an event of sPPH but not treated with NovoSeven®. Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.
• Outcomes:
  Occurrence of invasive procedures (yes/no) 20 min-24 hours following time0. Exposed women:Time0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. Matched controls:Time0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control. Occurrence of thromboembolic events (yes/no) from time0 until 5 days after time0. Amount of blood products transfused from delivery to 24h after time0 Estimated blood loss from delivery to 24h after time0 Occurrence of hysterectomy (yes/no) 20min-24hours following time0 (Time0 definition - see under primary outcomes.)
• Data analysis plan:
  The primary objective will be answered using propensity score matching to ensure exchangeability between sPPH patient treated with NovoSeven® and those that are not across all 4 cohorts (if these are comparable). These analyses will be addressed using data from the patient`s electronic record that includes timing of variables. To answer the secondary objectives, the comparisons will be made using the matched women from the propensity score matching described above. A significance level (alpha) of 0.05 will be used.