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

Postpartum Haemorrhage Clinical Trial

— TeMpOH-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149472
• Other study ID #: NL.46563.058.13
• Secondary ID: P13.246
• Status: Completed
• Start date: February 4, 2015
• Est. completion date: April 18, 2018

Study information

• Verified date: April 2018
• Source: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See 'brief summary'

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1649
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnancy, gestation age > 24 weeks

Exclusion Criteria:

• Age < 18

• Adults incapable of giving informed consent

• Gestational age < 24 weeks

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center (LUMC)	Leiden	Zuid-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research	Erasmus Medical Center, Isala, Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Postpartum haemorrhage within the 24 hrs hours after childbirth
Secondary	Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters		Postpartum haemorrhage within first 24 hrs after childbirth
Secondary	Incidence of underlying bleeding disorders in patients with MOH		3 months postpartum
Secondary	Predictive value bleeding score in pregnancy for MOH		Third trimester of pregnancy - 24 hours postpartum