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OpenTrials
Completed

NCT Number: NCT04753671

QUANTRA® References Range Protocol in Pregnancy and Postpartum

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.

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Key information

Conditions

Pregnancy Postpartum Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At admission (= before delivery )

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

    Time frame: At 30 minutes +/- 10 minutes after delivery

Secondary outcomes

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

    Time frame: At 30 up to 60 minutes after birth and placental removal.

  2. Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries)

    Time frame: At 30 up to 60 minutes after birth

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: QUANTRA®_GPP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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