Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
NCT ID: NCT02149472
Last Updated: 2018-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1649 participants
OBSERVATIONAL
2015-02-04
2018-04-18
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Adults incapable of giving informed consent
* Gestational age \< 24 weeks
18 Years
FEMALE
Yes
Sponsors
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Leiden University Medical Center
OTHER
Erasmus Medical Center
OTHER
Isala
OTHER
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
OTHER
Responsible Party
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Principal Investigators
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J G van der Bom, Prof, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
LUMC and Center for Clinical Transufion Research Sanquin
Locations
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Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands
Countries
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References
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Tahitu M, Ramler PI, Gillissen A, Caram-Deelder C, Henriquez DDCA, de Maat MPM, Duvekot JJ, Eikenboom J, Bloemenkamp KWM, van den Akker T, van der Bom JG. Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. Acta Obstet Gynecol Scand. 2022 Jan;101(1):145-152. doi: 10.1111/aogs.14279. Epub 2021 Nov 3.
Other Identifiers
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P13.246
Identifier Type: OTHER
Identifier Source: secondary_id
NL.46563.058.13
Identifier Type: -
Identifier Source: org_study_id
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