Towards better prognostic and diagnostic strategies for haemostatic changes leading to Major Obstetric Haemorrhage

Towards better prognostic and diagnostic strategies for haemostatic changes leading to Major Obstetric Haemorrhage - TeMpOH 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45065

Enrollment

9300

Registered

2014-02-05

Start date

2015-02-04

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe postpartum haemorrhage

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Pregnancy Gestational age > 24 weeks.

Exclusion criteria

Exclusion criteria: Gestational age

Design outcomes

Primary

Measure	Time frame
• Validation of a bleeding score assessment questionnaire in pregnant women • Development of a prediction model for MOH • Description of changes is haemostatic parameters during obstetric haemorrhage • Validation of ROTEM ® during obstetric haemorrhage • Association of MOH with underlying bleeding disorders • Maternal mortality • Severe maternal morbidity, defined as: • Peripartum hysterectomy • Peripartum arterial embolisation • ICU or Obstetrical High care Unit admittance • Intensive care unit admission or obstetric high care unit admission • Timing, amounts and type of allogeneic blood products • Timing, amounts and type of administered haemostatic agents: fibrinogen concentrate, tranexamic acid, recombinant factor VIIa	—

Measure

Time frame

• Validation of a bleeding score assessment questionnaire in pregnant women • Development of a prediction model for MOH • Description of changes is haemostatic parameters during obstetric haemorrhage • Validation of ROTEM ® during obstetric haemorrhage • Association of MOH with underlying bleeding disorders • Maternal mortality • Severe maternal morbidity, defined as: • Peripartum hysterectomy • Peripartum arterial embolisation • ICU or Obstetrical High care Unit admittance • Intensive care unit admission or obstetric high care unit admission • Timing, amounts and type of allogeneic blood products • Timing, amounts and type of administered haemostatic agents: fibrinogen concentrate, tranexamic acid, recombinant factor VIIa

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Countries

Netherlands

Outcome results