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

December 18, 2025 updated by: University Hospital, Lille

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: At admission (= before delivery )
At admission (= before delivery )
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Time Frame: At 30 minutes +/- 10 minutes after 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
Time Frame: At 30 up to 60 minutes after birth and placental removal.
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)
Time Frame: At 30 up to 60 minutes after birth
At 30 up to 60 minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

November 7, 2022

Study Completion (Actual)

November 7, 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)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Postpartum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe