CompletedNot Applicable

QUANTRA® References Range Protocol in Pregnancy and Postpartum

France31 participantsStarted 2021-05-05

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Description of the QUANTRA® parameters range intervals before and after vaginal delivery

Timeframe: At admission (= before delivery )

Description of the QUANTRA® parameters range intervals before and after vaginal delivery

Timeframe: At 30 minutes +/- 10 minutes after delivery

Trial details

NCT IDNCT04753671

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-07

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