MedTrace Logo

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

NCT02149472 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1649

Last updated 2018-05-01

No results posted yet for this study

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.

Conditions

  • Postpartum Haemorrhage

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Isala

    collaborator OTHER

  • Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

    lead OTHER

Principal Investigators

  • J G van der Bom, Prof, MD,PhD · LUMC and Center for Clinical Transufion Research Sanquin

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-04
Primary Completion
2018-04-18
Completion
2018-04-18

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149472 on ClinicalTrials.gov