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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Haemorrhage

Detailed Description

See 'brief summary'

• Study Type: Observational
• Enrollment (Actual): 1649

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2300RC
      • Leiden University Medical Center (LUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

- Pregnancy, gestation age > 24 weeks

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
• Collaborators: Erasmus Medical Center; Leiden University Medical Center; Isala
• Investigators: Principal Investigator: J G van der Bom, Prof, MD,PhD, LUMC and Center for Clinical Transufion Research Sanquin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2015
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: NL.46563.058.13; P13.246 (Other Identifier: Leiden University Medical Center (LUMC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided