Postpartum Hemorrhage
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DEVICETEG6S
Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician
Sponsors
Centre Hospitalier Sud Francilien
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman of 18 years old or more * Delivery at the level III maternity of Centre Hospitalier Sud Francilien (CHSF) (Corbeil-Essonnes, France) between 2022 and 2024, except deliveries during cyber-attack period at CHSF (from August 2022 to December 2022 included), due to uncertainty over the completeness of the data. * Presenting postpartum hemorrhage with estimated blood loss of 1000mL or more * No constitutional hemostasis anomaly * No treatment interfering with hemostasis * No use of blood products and/or pro-coagulant products before delivery
Exclusion criteria
\- Patient informed of the research and refusing the use of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrinogen consumption | up to 24 hours | Quantity of fibrinogen administered (in grams) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss | up to 24 hours | Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials |
| ICU admission | until leaving the hospital | Any admission in an intensive care unit |
| ICU length of stay | until discharge from the intensive care unit | Total length of stay in an intensive care unit/critical care (in days) |
| Calculated blood loss | up to 24 hours | 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). |
| Consumption of packed red blood cells (RBC) | up to 24 hours | Number of packed red blood cells used |
| Total number of TEG6S® | at 12 months | Total number of TEG6S® carried out over a period of 12 months following its implementation |
| Invasive haemostatic procedure | up to 24 hours | Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy) |
| Maternal death | until leaving the hospital | Occurrence of maternal death at hospital |
| Total length of stay | until discharge from the intensive care unit | Total length of stay in hospital (in days) |
| Acute anemia | at 24 hours | 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 |
| Consumption of fresh frozen plasma (FFP) | up to 24 hours | Number of fresh frozen plasma (FFP) used |
Countries
France
Outcome results
None listed