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

NCT ID: NCT04444856

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-01-13

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Postpartum Haemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NovoSeven

Women with severe postpartum haemorrhage treated with NovoSeven

Eptacog alfa (activated)

Intervention Type 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

Women with severe postpartum haemorrhage treated with standard of care

Standard of care

Intervention Type OTHER

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

Interventions

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Eptacog alfa (activated)

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.

Intervention Type DRUG

Standard of care

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

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EUPAS35429

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1248-2816

Identifier Type: OTHER

Identifier Source: secondary_id

NN7711-4729

Identifier Type: -

Identifier Source: org_study_id

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