Leiden University Medical Center (LUMC)
Leiden, South Holland, 2300RC, Netherlands
NCT Number: NCT02149472
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Leiden, South Holland, 2300RC, Netherlands
See 'brief summary'
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postpartum haemorrhage within first 24 hrs after childbirth
Time frame: 3 months postpartum
Time frame: Third trimester of pregnancy - 24 hours postpartum
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Other
Acronym: TeMpOH-2
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.
Published trials that share one or more normalized conditions with this study.
NCT01044082
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Paris, France
View Trial DetailsNCT02562300
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
View Trial DetailsNCT02704780
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Erbil, Kurdistan Region, Iraq
View Trial DetailsNCT00872469
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Ibadan, Nigeria
View Trial Details