An observational study in Postpartum Haemorrhage, sponsored by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research · Observational
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.
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445 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's enrollment of 1,649 is above the median of 152 across 91 observational studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire duing their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600) during the course of postpartum haemorrhage for evaluation of changes in haemostatic parameters and ROTEM profiles.
3 months postpartum a nested case cohort study will be performed to compare the incidences of underlying bleeding disorders in the haemorrhage and non-haemorrhage group. This outcome will also be related to the obtained bleeding scores during pregnancy.
Exclusion Criteria:
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
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.
Time frame: Postpartum haemorrhage within the 24 hrs hours after childbirth
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
Plan to share: Undecided
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research