Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)

NCT03592303 | Unknown

• 2 other identifiers: NI17042J2017-A02347-46
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coagulation Defect; Puerperal; Post Partum Hemorrhage; Blood Protein Disorders; Pregnancy Hemorrhage

Keywords

Post-partum haemorrhage; Thromboelastography; Coagulopathy; Fibrinogenemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Performance analysis of TEG6S RapidTEG parameters for the diagnosis of coagulation disorders in PPH.

  during the 24 hours after delivery.

• Performance analysis of TEG6S Functional Fibrinogen parameters for the diagnosis of coagulation disorders in PPH.

  during the 24 hours after delivery.

• Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.

  during the 24 hours after delivery.

• Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.standard laboratory tests.

  during the 24 hours after delivery.

• Analysis of the correlation between the parameters provided by TEG6S and standard laboratory tests.

  during the 24 hours after delivery.

Study Arms (2)

Control

Any pregnant patient with a normal pregnancy is eligible for possible participation in the study.

PPH group

Women with PPH requiring biological evaluation of hemostasis

Eligibility Criteria

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

Study Population

Any pregnant patient with a normal pregnancy is eligible for possible participation in the study. Two patient groups will be included : * Pregnant women during labor * Women with PPH requiring biological evaluation of hemostasis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Hemostatic Disorders; Postpartum Hemorrhage; Blood Protein Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; 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

• Agnès Rigouzzo

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnès Rigouzzo

CONTACT

+33171738969; agnes.rigouzzo@aphp.fr

Nicolas Louvet

CONTACT

+33171738946; nicolas.louvet@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: July 19, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 19, 2018

Record last verified: 2018-05

Locations

FR (1)