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

Completed

• Conditions: 10026906; Severe postpartum haemorrhage

• Registration Number: NL-OMON45065
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-04-18
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1659

Inclusion Criteria

Pregnancy
Gestational age > 24 weeks.

Exclusion Criteria

Gestational age < 24 weeks
Age < 18 years
Adults incapable of giving informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>