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

NCT04444856 | Completed

• 3 other identifiers: NN7711-4729EUPAS35429U1111-1248-2816
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Postpartum Haemorrhage

Outcome Measures

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.)

  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.

  20 min-24 hours following time 0

Secondary Outcomes (4)

• Occurrence of thromboembolic events (yes/no)

  From time 0 until 5 days after time 0

• Amount of blood products transfused

  From delivery to 24 hours after time 0

• Estimated blood loss

  From delivery to 24 hours after time 0

• Occurrence of hysterectomy (yes/no)

  20 min-24 hours following time 0

Study Arms (2)

NovoSeven

Women with severe postpartum haemorrhage treated with NovoSeven

Drug: Eptacog alfa (activated)

Standard of care

Women with severe postpartum haemorrhage treated with standard of care

Other: Standard of care

Interventions

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.

NovoSeven

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.

Standard of care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care

You may qualify if:

• Females
• sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bern, CH-3010, Switzerland

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Factor VII; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: June 29, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)