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

U

University Hospital, Lille

Status

Completed

Conditions

Pregnancy Postpartum

Study type

Observational

Funder types

Other

Identifiers

NCT04753671
2020-A03000-39 (Other Identifier)
2020_14

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Anne-Sophie DUCLOY-BOUTHORS, MD

Data sourced from clinicaltrials.gov

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