Examining blood clotting in pregnant women and the effects of low molecular weight heparin
Longitudinal Study of the in Vitro Action of Low Molecular Weight Heparin (LMWH) in Pregnant Women by Thrombinography
This study looks at how blood clotting changes during and after pregnancy to see if a blood thinner called low molecular weight heparin works better for pregnant women at risk of blood clots.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT06575309 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the changes in blood clotting mechanisms during pregnancy and the postpartum period, focusing on the risk of venous thromboembolism (VTE). It aims to analyze the pharmacokinetics of low molecular weight heparin (LMWH) in pregnant women and assess how physiological changes may affect its anticoagulant efficacy. By conducting blood tests, the study will gather data on coagulation factors and the impact of LMWH treatment. The findings could help optimize anticoagulant therapy for pregnant women at risk of thrombosis.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in their first trimester who are over 18 years old and do not have a history of coagulation disorders.
Not a fit: Patients with known coagulation diseases, a history of venous thromboembolism, or those currently using anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for venous thromboembolism in pregnant women.
How similar studies have performed: Other studies have indicated the importance of monitoring anticoagulant therapy during pregnancy, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Normal 1st trimester pregnancy * Age \> 18 Exclusion Criteria: * Coagulation disease (Von Willebrand disease, known coagulation factor deficiency before pregnancy) * VTE history * First-degree family history of idiopathic VTE * Known biological risk factor for thrombosis Inherited deficiencies in coagulation inhibitors (antithrombin, protein C, protein S) Factor V Leiden polymorphism Prothrombin gene 20210G\>A polymorphism Anti-phospholipid antibodies * Current anticoagulant use (VKA, heparins, etc.) * Gestational diabetes detected in the 1st trimester * Pre-existing type 1 and type 2 diabetes * History of pathological pregnancy Premature delivery Postpartum hemorrhage Preeclampsia * Hepatopathy * Obesity (BMI ≥ 30) * Infections (HIV, HBV, HCV...) * Autoimmune diseases * Pregnancy resulting from in vitro fertilization protocol * Multiple pregnancy * Patient under guardianship, curatorship or safeguard of justice * Patient not covered by a social security scheme * Patient deprived of liberty
Where this trial is running
Clermont-Ferrand and 1 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU Estaing — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Aurélien Lebreton — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.