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The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).
Acquired obstetrical coagulopathy during massive postpartum hemorrhage (PPH) is a serious and frequent complication of delivery. It has been shown that fibrinogen levels are the first to fall during PPH, and that a level inferior to a threshold of 2g/L is strongly associated with progression to severe PPH, hemostatic impairment, transfusion, and invasive hemostatic procedures.
The clinical diagnosis of coagulopathy is difficult, and the biological diagnosis by usual laboratory tests is often delayed, leading to the empirical administration of fibrinogen and blood products, sometimes unnecessary.
The TEG6S® is a viscoelastic testing device performed on whole blood, which allows a reliable assessment of hemostasis and coagulation quality in about ten minutes.
The anomalies detected by the TEG6S® allow for the early diagnosis of acquired coagulopathy, especially hypofibrinogenemia. Its use during the management of PPH would therefore allow for transfusion savings and potential economic benefits, in addition to improving patient prognosis through early and appropriate treatment (including the absence of early "blind" treatment in the absence of coagulopathy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before TEG6S | Patients managed in a period of 12 months before the implementation of TEG6S® | ||
| After TEG6S | Patients managed in a period of 12 months after the implementation of TEG6S® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG6S | Device | Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrinogen consumption | Quantity of fibrinogen administered (in grams) | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of TEG6S® | Total number of TEG6S® carried out over a period of 12 months following its implementation | at 12 months |
| Estimated blood loss | Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials |
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Inclusion Criteria:
Exclusion Criteria:
- Patient informed of the research and refusing the use of the data
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Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.
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| Name | Affiliation | Role |
|---|---|---|
| Fatima BRIK | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | 91106 | France |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| up to 24 hours |
| Calculated blood loss | Estimated total volume of blood loss during PPH, using the following formula = ([initial Ht - Ht H24] × total blood volume × 100/35) + compensated blood loss (CBL) ; with: total blood volume in milliliters = basis weight × 65 × 1.4, and CBL in milliliters, corresponding to the number of RBC concentrates transfused (1 RBC corresponds to approximately 500 mL of blood at 35% Ht). | up to 24 hours |
| Consumption of packed red blood cells (RBC) | Number of packed red blood cells used | up to 24 hours |
| Consumption of fresh frozen plasma (FFP) | Number of fresh frozen plasma (FFP) used | up to 24 hours |
| Invasive haemostatic procedure | Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy) | up to 24 hours |
| Maternal death | Occurrence of maternal death at hospital | until leaving the hospital |
| ICU admission | Any admission in an intensive care unit | until leaving the hospital |
| ICU length of stay | Total length of stay in an intensive care unit/critical care (in days) | until discharge from the intensive care unit |
| Total length of stay | Total length of stay in hospital (in days) | until discharge from the intensive care unit |
| Acute anemia | Occurrence of anemia following postpartum hemorrhage, defined by a decrease in hemoglobin level of 4g/dL or more at 24h following delivery, compared to the last hemoglobin level known before delivery | at 24 hours |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |