Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage

Completed

• Conditions: Postpartum Haemorrhage

• Registration Number: NCT02149472
• Lead Sponsor: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Brief Summary

Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken.

In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage.

A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated.

If postpartum haemorrhage develops (blood loss) \> 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated.

The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.

Detailed Description

See 'brief summary'

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-29
• Study Start: 2015-02-04
• Status Verified: 2018-04
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1649

Inclusion Criteria

• Pregnancy, gestation age > 24 weeks

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early haemostatic predictors of major obstetric haemorrhage	Postpartum haemorrhage within the 24 hrs hours after childbirth	During early postpartum haemorrhage changes in hemostatic parameters leading to major obstetric haemorrhage will be identified. Conventional hemostatic parameters and ROTEM profiles will be studied.

Secondary Outcome Measures

Name	Time	Method
Predictive value bleeding score in pregnancy for MOH	Third trimester of pregnancy - 24 hours postpartum
Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters	Postpartum haemorrhage within first 24 hrs after childbirth
Incidence of underlying bleeding disorders in patients with MOH	3 months postpartum

Trial Locations

Locations (1)

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Zuid-Holland, Netherlands