Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage

NCT06473233 | Completed

• 1 other identifier: 2024/0013
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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).

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Fibrinogen consumption

  Quantity of fibrinogen administered (in grams)

  up to 24 hours

Secondary Outcomes (11)

• Total number of TEG6S®

  at 12 months

• Estimated blood loss

  up to 24 hours

• Calculated blood loss

  up to 24 hours

• Consumption of packed red blood cells (RBC)

  up to 24 hours

• Consumption of fresh frozen plasma (FFP)

  up to 24 hours

Study Arms (2)

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®

Device: TEG6S

Interventions

TEG6S DEVICE

Hemostatic management including one or more delocalized biology test with the TEG6S®, at the discretion of the responsible clinician

After TEG6S

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women who gave birth at the level III maternity of Centre Hospitalier Sud Francilien and had postpartum haemorrhage greater than 1000mL or more.

You may qualify if:

• 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

You may not qualify if:

• \- Patient informed of the research and refusing the use of the data

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatima BRIK

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 25, 2024
• Study Start: October 9, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)