Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 12, 2014
First Posted Date May 29, 2014
Last Update Posted Date May 1, 2018
Actual Study Start Date February 4, 2015
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02149472 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2014)
  • Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters [ Time Frame: Postpartum haemorrhage within first 24 hrs after childbirth ]
  • Incidence of underlying bleeding disorders in patients with MOH [ Time Frame: 3 months postpartum ]
  • Predictive value bleeding score in pregnancy for MOH [ Time Frame: Third trimester of pregnancy - 24 hours postpartum ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
Official Title Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
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.

Detailed Description See 'brief summary'
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. Remaining plasma will be frozen and stored for further evaulation.
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.

Condition Postpartum Haemorrhage
Intervention Not Provided
Study Groups/Cohorts 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2018)
1649
Original Estimated Enrollment
 (submitted: May 23, 2014)
9500
Actual Study Completion Date April 18, 2018
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Pregnancy, gestation age > 24 weeks

Exclusion Criteria:

  • Age < 18
  • Adults incapable of giving informed consent
  • Gestational age < 24 weeks
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02149472
Other Study ID Numbers NL.46563.058.13
P13.246 ( Other Identifier: Leiden University Medical Center (LUMC) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Study Sponsor Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Collaborators
  • Leiden University Medical Center
  • Erasmus Medical Center
  • Isala
Investigators
Principal Investigator: J G van der Bom, Prof, MD,PhD LUMC and Center for Clinical Transufion Research Sanquin
PRS Account Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Verification Date April 2018