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QUANTRA® References Range Protocol in Pregnancy and Postpartum

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04753671
Acronym
QUANTRA®_GPP
Enrollment
31
Registered
2021-02-15
Start date
2021-05-05
Completion date
2022-11-07
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Postpartum

Keywords

Hemostasis, pregnancy, postpartum, point of care, coagulopathy

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Description of the QUANTRA® parameters range intervals before and after vaginal deliveryAt admission (= before delivery )

Secondary

MeasureTime frame
Description of the QUANTRA® parameters range intervals before and after vaginal deliveryAt 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026