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Completed

NCT Number: NCT04444856

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

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.

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Key information

Conditions

Severe Postpartum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bern, CH-3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eptacog alfa (activated)

Drug

The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.

Standard of care

Other

The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.

Primary outcomes

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

    Time frame: 20 min-24 hours following time 0

    Count of participants (yes/no)

    Time 0 definition for all endpoints:

    Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 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.

Secondary outcomes

  1. Occurrence of thromboembolic events (yes/no)

    Time frame: From time 0 until 5 days after time 0

    Count of participants (yes/no)

  2. Amount of blood products transfused

    Time frame: From delivery to 24 hours after time 0

    Units

  3. Estimated blood loss

    Time frame: From delivery to 24 hours after time 0

    mL

  4. Occurrence of hysterectomy (yes/no)

    Time frame: 20 min-24 hours following time 0

    Count of participants (yes/no)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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