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Completed

NCT Number: NCT02149472

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2300RC, Netherlands

About this study

See 'brief summary'

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy, gestation age > 24 weeks

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Erasmus Medical Center
  • Isala
  • Leiden University Medical Center

Registry information

Acronym: TeMpOH-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 29, 2014
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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