CompletedNot Applicable

Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern

Switzerland225 participantsStarted 2020-06-29

Plain-language summary

This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.

Who can participate

SexFEMALE

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Inclusion Criteria: * Females * sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery * Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort) Exclusion Criteria: * There are no exclusion criteria

What they're measuring

Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)

Timeframe: 20 min-24 hours following time 0

Trial details

NCT IDNCT04444856

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-01-13

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