Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage (TeMpOH-2)
|ClinicalTrials.gov Identifier: NCT02149472|
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 1, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1649 participants|
|Official Title:||Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage|
|Actual Study Start Date :||February 4, 2015|
|Actual Primary Completion Date :||April 18, 2018|
|Actual Study Completion Date :||April 18, 2018|
Pregnant women with PPH
All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire during their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600).
- Early haemostatic predictors of major obstetric haemorrhage [ Time Frame: 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.
- Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters [ Time Frame: Postpartum haemorrhage within first 24 hrs after childbirth ]
- Incidence of underlying bleeding disorders in patients with MOH [ Time Frame: 3 months postpartum ]
- Predictive value bleeding score in pregnancy for MOH [ Time Frame: Third trimester of pregnancy - 24 hours postpartum ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149472
|Leiden University Medical Center (LUMC)|
|Leiden, Zuid-Holland, Netherlands, 2300RC|
|Principal Investigator:||J G van der Bom, Prof, MD,PhD||LUMC and Center for Clinical Transufion Research Sanquin|