QUANTRA® References Range Protocol in Pregnancy and Postpartum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-11-07

Brief Summary

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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

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Conditions

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Pregnancy Postpartum

Keywords

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Hemostasis pregnancy postpartum point of care coagulopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Sophie DUCLOY-BOUTHORS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Countries

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France

References

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Lukowiak O, Le Gouez A, Djebbour M, Mercier FJ, Bouthors AS. Peri-partum reference range for the point-of-care viscoelastic testing device Quantra(R) QStat in healthy pregnancy and non-haemorrhagic post-partum - A short communication. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101521. doi: 10.1016/j.accpm.2025.101521. Epub 2025 Apr 17.

Reference Type RESULT

PMID: 40252700 (View on PubMed)

Other Identifiers

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2020-A03000-39

Identifier Type: OTHER

Identifier Source: secondary_id

2020_14

Identifier Type: -

Identifier Source: org_study_id