Pregnancy PostpartumQUANTRA®_GPPNCT04753671
QUANTRA® References Range Protocol in Pregnancy and Postpartum
An observational study of Pregnancy Postpartum, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Postpartum
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2021to 7 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: a cohort of Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
Who may be able to join
- 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
Who cannot join
- Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device
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.
- Conditions
- Pregnancy Postpartum
- Keywords
- Hemostasis, pregnancy, postpartum, point of care, coagulopathy
- Medical subject headings
- Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Measured: At admission (= before delivery )
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Measured: At 30 minutes +/- 10 minutes after delivery
Secondary outcomes (2)
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Measured: At 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)
Measured: At 30 up to 60 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start5 May 2021
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie DUCLOY-BOUTHORS, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753671
- Sponsor's protocol ID
- 2020_14
- Other IDs
- 2020-A03000-39
- Acronym
- QUANTRA®_GPP
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lukowiak O, Le Gouez A, Djebbour M, Mercier FJ, Bouthors AS. Peri-partum reference range for the point-of-care viscoelastic testing device Quantra(R) QStat in healthy pregnancy and non-haemorrhagic post-partum - A short communication. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101521. doi: 10.1016/j.accpm.2025.101521. Epub 2025 Apr 17.
PubMed 40252700
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device
- ClinicalTrials.gov ID
- NCT04753671
- Acronym / sponsor ID
- QUANTRA®_GPP / 2020_14
- Conditions
- Pregnancy Postpartum
- Keywords
- Hemostasis, pregnancy, postpartum, point of care, coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a cohort of Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Time frame: At admission (= before delivery )
Description of the QUANTRA® parameters range intervals before and after vaginal delivery
Time frame: At 30 minutes +/- 10 minutes after delivery
2 secondary outcomes
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 40252700Lukowiak O, Le Gouez A, Djebbour M, Mercier FJ, Bouthors AS. Peri-partum reference range for the point-of-care viscoelastic testing device Quantra(R) QStat in healthy pregnancy and non-haemorrhagic post-partum - A short communication. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101521. doi: 10.1016/j.accpm.2025.101521. Epub 2025 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie DUCLOY-BOUTHORS, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Postpartum, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the QUANTRA® parameters range intervals before and after vaginal delivery (time frame: At admission (= before delivery )). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.