QUANTRA® References Range Protocol in Pregnancy and Postpartum

• Conditions: Pregnancy Postpartum

• Registration Number: NCT04753671
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-05-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the QUANTRA® parameters range intervals before and after vaginal delivery	At 30 minutes +/- 10 minutes after delivery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France