QUANTRA® References Range Protocol in Pregnancy and Postpartum

Pregnancy Postpartum Clinical Trial

— QUANTRA®_GPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753671
• Other study ID #: 2020_14
• Secondary ID: 2020-A03000-39
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Anne-Sophie DUCLOY-BOUTHORS, MD
• Phone: 0320445962
• Email: anne-sophie.bouthors[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Postpartum

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the QUANTRA® parameters range intervals before and after vaginal delivery		At admission (= before delivery )
Primary	Description of the QUANTRA® parameters range intervals before and after vaginal delivery		At 30 minutes +/- 10 minutes after delivery
Secondary	Description of the QUANTRA® parameters range intervals before and after vaginal delivery		At 30 up to 60 minutes after birth and placental removal.
Secondary	Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries)		At 30 up to 60 minutes after birth