Actively Recruiting
Longitudinal Study of the in Vitro Action of Low Molecular Weight Heparin in Pregnant Women by Thrombinography
Led by University Hospital, Clermont-Ferrand · Updated on 2026-05-29
50
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how pregnancy affects blood clotting and how low-molecular-weight heparin (LMWH), a common blood thinner, works during pregnancy. Pregnancy causes changes in blood factors that increase clotting risk, which protects against bleeding during childbirth but raises the chance of venous thromboembolism (VTE). The study aims to understand the balance of clotting using thrombinography, a test measuring thrombin generation, to evaluate coagulation changes over the three trimesters, postpartum, and after pregnancy. The study observes pregnant women by collecting blood samples to analyze thrombin generation before and after adding LMWH in the lab. This will track changes longitudinally through pregnancy stages and postpartum. The research focuses on how the anticoagulant effect of LMWH might vary during pregnancy due to physiological changes and explores if dose adjustments are needed to avoid under- or overdosing. Participants will have multiple blood samples taken over approximately one year to assess clotting profiles using thrombinography. Researchers will measure various parameters such as endogenous thrombin potential, lag time, peak height, time to peak, start tail, and velocity index. This detailed monitoring will help evaluate the impact of LMWH on coagulation and support future studies to optimize anticoagulant therapy in pregnant women.
CONDITIONS
Brief Title
THROmbinography in Pregnant Woman and in Vitro Action of Low Molecular Weight HEparin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal first trimester pregnancy
- Age greater than 18 years
- Female gender
You will not qualify if you...
- History of coagulation diseases such as Von Willebrand disease or known coagulation factor deficiencies before pregnancy
- History of venous thromboembolism (VTE)
- First-degree family history of unexplained VTE
- Known inherited biological risk factors for thrombosis including deficiencies in antithrombin, protein C, protein S, Factor V Leiden polymorphism, Prothrombin gene 20210G>A polymorphism, or anti-phospholipid antibodies
- Current use of anticoagulant medications like vitamin K antagonists or heparins
- Gestational diabetes detected in the first trimester
- Pre-existing type 1 or type 2 diabetes
- History of pathological pregnancy including premature delivery, postpartum hemorrhage, or preeclampsia
- Liver disease
- Obesity with body mass index of 30 or higher
- Infections such as HIV, HBV, or HCV
- Autoimmune diseases
- Pregnancy resulting from in vitro fertilization
- Multiple pregnancy
- Legal guardianship or curatorship
- Not covered by a social security scheme
- Being deprived of liberty or under legal custody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants undergo longitudinal blood sample collections to evaluate thrombin generation during pregnancy, post-partum, and post-pregnancy.
6 blood sample visits over the course of pregnancy and post-partum
Trial Site Locations
Total: 2 locations
1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Not Yet Recruiting
2
CHU Estaing
Clermont-Ferrand, France, 63003
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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