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NCT04753671: QUANTRA®_GPP

QUANTRA® References Range Protocol in Pregnancy and Postpartum

Completed Last updated 26 December 2025
What this trial tests

trial in Pregnancy Postpartum in 31 participants. Completed in 7 November 2022.

Timeline
5 May 2021
Primary endpoint
7 November 2022
7 November 2022

Quick facts

Lead sponsorUniversity Hospital, Lille
StatusCompleted
Study typeOBSERVATIONAL
Enrollment31
Start date5 May 2021
Primary completion7 November 2022
Estimated completion7 November 2022
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Lille

Who can join

18 and older, female only, with Pregnancy Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Peri-partum reference range for the point-of-care viscoelastic testing device Quantra® QStat in healthy pregnancy and non-haemorrhagic post-partum - A short communication.
    Lukowiak O, Le Gouez A, Djebbour M, Mercier FJ, et al · · 2025 · cited 1× · PMID 40252700 · DOI 10.1016/j.accpm.2025.101521

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Trials by the same sponsor.

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