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

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

Sponsors

Source

Novo Nordisk A/S

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.

Overall Status

Not yet recruiting

Start Date

June 22, 2020

Completion Date

July 31, 2020

Primary Completion Date

July 31, 2020

Study Type

Observational

Primary Outcome

Measure	Time Frame
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)	20 min-24 hours following time 0. (Time 0 is the timepoint of administration of NovoSeven® for the exposed women and the timepoint for their matched controls where they have a propensity score similar to that of the NovoSeven® exposed women.)

Secondary Outcome

Measure	Time Frame
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 minutes to 24 hours following time 0

Enrollment

225

Condition

Severe Postpartum Haemorrhage

Intervention

Intervention type: Drug

Intervention name: Eptacog alfa (activated)

Description: 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.

Arm group label: NovoSeven

Intervention type: Other

Intervention name: Standard of care

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

Arm group label: Standard of care

Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official

Last Name	Role	Affiliation
Clinical Reporting Anchor and Disclosure (1452)	Study Director	Novo Nordisk A/S

Overall Contact

Last name: Novo Nordisk

Phone: (+1) 866-867-7178

Email: [email protected]

Location

facility

Novo Nordisk Investigational Site

Location Countries

Switzerland

Verification Date

June 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access

Condition Browse

Arm Group

Arm group label: NovoSeven

Description: Women with severe postpartum haemorrhage treated with NovoSeven

Arm group label: Standard of care

Description: Women with severe postpartum haemorrhage treated with other standard of care

Patient Data

Yes

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov