Normal PregnancyGRAPLNCT06133621
Determination of Reference Values for Diluted Russell's Viper Venom Time (dRVVT) Specific to Pregnant Women (GRAPL)
An observational study of Normal Pregnancy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Pregnancy
- What is being tested?
- dosage dRVVT
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2024to 28 Sep 2025
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Selection by the gynaecologist of pregnant women at the Croix Rousse maternity hospital, who presenting a physiological pregnancy with no history of thromboembolic or autoimmune pathology or vascular disease of pregnancy
Who may be able to join
- Control group :
- patients with normal pregnancies at the HCL.
- Affiliation to a social security regime
- Case group :
- Patients followed at the HCL who had an increased dRVVT ratio during pregnancy, investigated as part of the development of VDP during pregnancy.
- Affiliation to a social security regime
Who cannot join
- History of thromboembolic disease
- History of autoimmune disease
- History of VDP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thrombophilia Assessment and Pregnancy: Determination of Reference Values for dRVVT in Pregnant Women
Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women from delivery haemorrhage, but exposing them to a major thromboembolic risk.
Vascular diseases of pregnancy (VDP) are obstetric diseases which are linked to an ischaemic origin associated with placental thrombosis. These include pre-eclampsia, retroplacental haematoma, intrauterine growth retardation and even foetal death in utero. A number of risk factors have been identified for these VDPs, some of which have extremely serious consequences, the main one being antiphospholipid syndrome (APS).
Read more
The diagnosis of VDP in a current or previous pregnancy requires close monitoring and joint management by an obstetrician, haemostasis physician, internist and medical biologist, particularly in terms of pre, peri- and post-partum anticoagulation in patients at increased risk of thromboembolism.
The aim of treating APS during pregnancy is : to reduce the occurrence of maternal arterial or venous thrombotic complications in one hand and in the other hand to reduce the occurrence of obstetric complications, which are responsible of a significant morbimortality rate. The detection of a possible APS during pregnancy will therefore determine the specific management of patients.
The latest guidelines from the Groupe Français d'Etude sur l'Hémostase et la Thrombose (GFHT) in 2022 recommended a diluted Russell's viper venom time (dRVVT) and an activated partial thromboplastin time (APTT) measured using a sensitive reagent such as silica (SCT) should be used to assess the presence of LA.
Read the detailed description
Please remove all personal pronouns. For example, please change "we" to "the investigators" and "you" to "participants." The "Control + Find" function (Ctrl+F) can be used to locate personal pronouns throughout the record.
- Conditions
- Normal Pregnancy
- Being tested
- dosage dRVVT
- Keywords
- Pregnancy, Thrombophilia, Antiphospholipid syndrome, Vascular diseases of pregnancy, Diluted Russell viper venom time
- Medical subject headings
- Thrombophilia, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage dRVVTOther
Blood test dRVVT assay on two tubes of blood in the haemostasis laboratory of the Center de Biologie et de Pathologie Est
| Study group | Role | What they receive |
|---|---|---|
| cases | Patients treated at HCL who have had an increased dRVVT ratio during pregnancy, investigated in the context of the development of VDP during pregnancy Receives: Other: dosage dRVVT | |
| Controls | Patients with normal pregnancies followed at the Croix Rousse maternity hospital Receives: Other: dosage dRVVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
dRVVT value during pregnancy.
Carrying out the dRVVT in the haemostasis laboratory of the Centre de Biologie et de Pathologie Est
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start28 Mar 2024
- Primary completion28 Sep 2025
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline DR BAZIN, DR, Principal investigator, Laboratoire d'hémostase CBPE HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133621
- Sponsor's protocol ID
- 69HCL23_1016
- Acronym
- GRAPL
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombophilia Assessment and Pregnancy: Determination of Reference Values for dRVVT in Pregnant Women
- ClinicalTrials.gov ID
- NCT06133621
- Acronym / sponsor ID
- GRAPL / 69HCL23_1016
- Conditions
- Normal Pregnancy
- Keywords
- Pregnancy, Thrombophilia, Antiphospholipid syndrome, Vascular diseases of pregnancy, Diluted Russell viper venom time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 15 Nov 2023 (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.
Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women from delivery haemorrhage, but exposing them to a major thromboembolic risk.
Vascular diseases of pregnancy (VDP) are obstetric diseases which are linked to an ischaemic origin associated with placental thrombosis. These include pre-eclampsia, retroplacental haematoma, intrauterine growth retardation and even foetal death in utero. A number of risk factors have been identified for these VDPs, some of which have extremely serious consequences, the main one being antiphospholipid syndrome (APS).
The diagnosis of VDP in a current or previous pregnancy requires close monitoring and joint management by an obstetrician, haemostasis physician, internist and medical biologist, particularly in terms of pre, peri- and post-partum anticoagulation in patients at increased risk of thromboembolism.
The aim of treating APS during pregnancy is : to reduce the occurrence of maternal arterial or venous thrombotic complications in one hand and in the other hand to reduce the occurrence of obstetric complications, which are responsible of a significant morbimortality rate. The detection of a possible APS during pregnancy will therefore determine the specific management of patients.
The latest guidelines from the Groupe Français d'Etude sur l'Hémostase et la Thrombose (GFHT) in 2022 recommended a diluted Russell's viper venom time (dRVVT) and an activated partial thromboplastin time (APTT) measured using a sensitive reagent such as silica (SCT) should be used to assess the presence of LA.
Detailed description
Please remove all personal pronouns. For example, please change "we" to "the investigators" and "you" to "participants." The "Control + Find" function (Ctrl+F) can be used to locate personal pronouns throughout the record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: dosage dRVVTPatients treated at HCL who have had an increased dRVVT ratio during pregnancy, investigated in the context of the development of VDP during pregnancy |
| Controls | – | Other: dosage dRVVTPatients with normal pregnancies followed at the Croix Rousse maternity hospital |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Selection by the gynaecologist of pregnant women at the Croix Rousse maternity hospital, who presenting a physiological pregnancy with no history of thromboembolic or autoimmune pathology or vascular disease of pregnancy
Key inclusion criteria (6 listed)
- patients with normal pregnancies at the HCL.
- Affiliation to a social security regime
- Patients followed at the HCL who had an increased dRVVT ratio during pregnancy, investigated as part of the development of VDP during pregnancy.
- Affiliation to a social security regime
Key exclusion criteria (3 listed)
- History of thromboembolic disease
- History of autoimmune disease
- History of VDP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dosage dRVVTBlood test dRVVT assay on two tubes of blood in the haemostasis laboratory of the Center de Biologie et de Pathologie Est | Other | Controls, cases |
Primary outcome
dRVVT value during pregnancy.
Time frame: through study completion, an average of 9 months
Carrying out the dRVVT in the haemostasis laboratory of the Centre de Biologie et de Pathologie Est
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 2 Jan 2026.
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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.
Céline DR BAZIN, DR principal investigator
Laboratoire d'hémostase CBPE HCL
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 Normal Pregnancy, run by Hospices Civils de Lyon 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 6 inclusion and 3 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 2 Jan 2026. 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?
dRVVT value during pregnancy. (time frame: through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.