Post Partum Hemorrhage Clinical Trial
— HPPTEG6SOfficial title:
Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)
Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is
directly influenced by the early diagnosis and treatment of the associated coagulopathy. In
this context, fibrinogen concentration is the best predictor of a severe PPH. The medical
interest of thromboelastography/elastometry to early detect and guide the rapid correction of
coagulopathy in PPH is regularly discussed.
The principal aim of this study is to evaluate the performance of a new hemostasis point of
care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH.
A secondary aim will be to determine the normal values of TEG6S at the end of a normal
pregnancy.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | March 2019 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years old - Patient with health insurance - Group of patients during labor : any pregnant woman with a normal pregnancy in the delivery room. - Group of patients with PPH: any woman with a normal pregnancy experiencing a PPH with blood loss greater than 500 mL and who requires a biological evaluation of haemostasis. Exclusion Criteria: - Coagulopathy pre-existing to pregnancy - Medication that interferes with blood coagulation - Hepato-cellular insufficiency - Renal failure - Psychiatric care patients - Patient deprived of liberty by judicial or administrative decision - Major patient undergoing legal protective measures |
Country | Name | City | State |
---|---|---|---|
France | Hopital Trousseau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance analysis of TEG6S kaolin parameters for the diagnosis of coagulation disorders in PPH. | The performance analysis of the parameters derived from the Kaolin test will be performed using ROC curves and a sensitivity and specificity calculation. | during the 24 hours after delivery | |
Secondary | Performance analysis of TEG6S RapidTEG parameters for the diagnosis of coagulation disorders in PPH. | The performance analysis of the parameters derived from the RapidTEG test will be performed using ROC curves and a sensitivity and specificity calculation. | during the 24 hours after delivery. | |
Secondary | Performance analysis of TEG6S Functional Fibrinogen parameters for the diagnosis of coagulation disorders in PPH. | The performance analysis of the parameters derived from Functional Fibrinogen test will be performed using ROC curves and a sensitivity and specificity calculation. | during the 24 hours after delivery. | |
Secondary | Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests. | Analysis of correlation between the parameters of CFF test and laboratory tests. | during the 24 hours after delivery. | |
Secondary | Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.standard laboratory tests. | analysis of correlation between the parameters of CK test and laboratory tests. | during the 24 hours after delivery. | |
Secondary | Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests. | analysis of correlation between the parameters of CRT test and laboratory tests. | during the 24 hours after delivery. | |
Secondary | Performance of TEG6S parameters for predicting severe HPP | Blood loss will be calculated 24 hours after delivery, based on demographic data and hematocrit (Ht) values measured in the last month of pregnancy and 24 hours after delivery. | 24 hours after delivery. | |
Secondary | Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters. | The time taken to obtain the TEG6S parameter CK-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S. | during 24 hours after delivery | |
Secondary | Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters. | The time taken to obtain the TEG6S parameter CRT-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S. | during 24 hours after delivery | |
Secondary | Comparison of the time taken to obtain the different TEG6S parameters versus standard biology parameters. | The time taken to obtain the TEG6S parameter FF-MA will be measured. It corresponds to the time between the start of the analysis (including the start of the test) and the time the result is provided by the TEG6S. | during 24 hours after delivery | |
Secondary | Define normal reference values for TEG6S Thromboelastography in pregnant women during labor. | 2.9 mL of additional blood will be collected for TEG6S analysis. | during 24 hours after delivery |
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