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Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage (TeMpOH-2)

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ClinicalTrials.gov Identifier: NCT02149472
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Leiden University Medical Center
Erasmus Medical Center
Isala
Information provided by (Responsible Party):
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.


Condition or disease
Postpartum Haemorrhage

Detailed Description:
See 'brief summary'

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Study Type : Observational
Actual Enrollment : 1649 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters [ Time Frame: Postpartum haemorrhage within first 24 hrs after childbirth ]
  2. Incidence of underlying bleeding disorders in patients with MOH [ Time Frame: 3 months postpartum ]
  3. Predictive value bleeding score in pregnancy for MOH [ Time Frame: Third trimester of pregnancy - 24 hours postpartum ]

Biospecimen Retention:   Samples With DNA
Blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. Remaining plasma will be frozen and stored for further evaulation.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

- Pregnancy, gestation age > 24 weeks

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149472


Locations
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Netherlands
Leiden University Medical Center (LUMC)
Leiden, Zuid-Holland, Netherlands, 2300RC
Sponsors and Collaborators
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Leiden University Medical Center
Erasmus Medical Center
Isala
Investigators
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Principal Investigator: J G van der Bom, Prof, MD,PhD LUMC and Center for Clinical Transufion Research Sanquin

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Responsible Party: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
ClinicalTrials.gov Identifier: NCT02149472     History of Changes
Other Study ID Numbers: NL.46563.058.13
P13.246 ( Other Identifier: Leiden University Medical Center (LUMC) )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Hemostatics
Coagulants