Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device

University Hospital, Lille1 site in 1 country31 target enrollmentMay 5, 2021

ConditionsPregnancy Postpartum

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnancy Postpartum
Sponsor: University Hospital, Lille
Enrollment: 31
Locations: 1
Primary Endpoint: Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.

Registry

clinicaltrials.gov

Start Date

May 5, 2021

End Date

November 7, 2022

Last Updated

4 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
•Delivering vaginally without postpartum hemorrhage for 60 patients
•Delivering through a programmed C-section for 20 patients
•Having given a non-opposition agreement to participate in the study.
•Major patient with social insurance

Exclusion Criteria

•Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.

Outcomes

Primary Outcomes

Description of the QUANTRA® parameters range intervals before and after vaginal delivery

Time Frame: At 30 minutes +/- 10 minutes after delivery

Secondary Outcomes

Description of the QUANTRA® parameters range intervals before and after vaginal delivery(At 30 up to 60 minutes after birth and placental removal.)
Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries)(At 30 up to 60 minutes after birth)