QUANTRA® References Range Protocol in Pregnancy and Postpartum (QUANTRA®_GPP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Postpartum

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Anne-Sophie DUCLOY-BOUTHORS, MD; Phone Number: +33 0320445962; Email: anne-sophie.bouthors@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

a cohort of Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Description of the QUANTRA® parameters range intervals before and after vaginal delivery	At admission (= before delivery )
Description of the QUANTRA® parameters range intervals before and after vaginal delivery	At 30 minutes +/- 10 minutes after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Anne-Sophie Ducloy-Bouthors, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: point of care; pregnancy; Hemostasis; postpartum; coagulopathy
• Other Study ID Numbers: 2020_14; 2020-A03000-39 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No