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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01120-47 | Other Identifier | ANSM |
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The primary objective of this study is to demonstrate that plasma concentrations of nucleosomes and free DNA differ between three groups:
Our secondary objectives include the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group P: pregnancy w/complications | The patient is pregnant and has complications typical of placental vascular disease (preeclampsia, eclampsia, HELLP syndrome, retro-placental hematoma, in utero fetal death) or venous thromboembolism (deep vein thrombosis, pulmonary embolism). 100 patients will be included. Interventions to be administered: Bloodwork, baseline |
| |
| Group T1: Healthy volunteers | Healthy volunteers with no history of chronic or neoplastic disease. 30 healthy volunteers will be included. Interventions to be administered: Bloodwork, baseline |
| |
| Group T2: Pregnancy, no complications | Pregnant patients with no identifiable pregnancy complications, and no history of chronic or neoplastic disease. 50 pregnant volunteers will be included. Interventions to be administered: Bloodwork, baseline |
| |
| Group T1x: 15 Healthy volunteers | 15 Healthy volunteers selected from group T1 (the first 15). These patients will have 2 additional months of follow up. Interventions to be administered: Blood work, Months 1 & 2 |
| |
| Group T2x: 15 Pregnancy, no complications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloodwork, baseline | Biological | 36 ml of blood are drawn at baseline (last month of pregnancy for groups P and T2, inclusion for group T1) in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146. |
| Measure | Description | Time Frame |
|---|---|---|
| Total plasma concentration of free DNA (ng/ml) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | Base line (day 0) |
| Total plasma concentration of nucleosomes (AU) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth | Base line (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Platelets (g/l) |
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Inclusion Criteria for all patients:
Inclusion Criteria for patients in group P:
Inclusion Criteria for patients in group T1:
Inclusion Criteria for patients in group T2:
Exclusion Criteria for all patients:
Exclusion Criteria for group P:
Exclusion Criteria for group T1:
Exclusion Criteria for group T2:
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The study population includes three groups:
Group P: 100 pregnant women with complications typical of placental vascular disease or venous thromboembolism.
Group T1: 30 non-pregnant, healthy volunteers
Group T2: 50 pregnant, healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Bouvier, MD | Centre Hospitalier Universitaire de NÄ«mes | Study Director |
| Eve Mousty, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32979032 | Result | Bouvier S, Mousty E, Fortier M, Demattei C, Mercier E, Nouvellon E, Chea M, Grosjean F, Letouzey V, Gris JC. Placenta-mediated complications: Nucleosomes and free DNA concentrations differ depending on subtypes. J Thromb Haemost. 2020 Dec;18(12):3371-3380. doi: 10.1111/jth.15105. Epub 2020 Oct 18. | |
| 35559998 | Derived |
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At each visit a total of 36 ml of blood will be drawn (5 x EDTA tube = 5 x 4.5ml; 2 x CTAD tube = 2 x 4.5 ml and 1 dry tube = 4.5 ml).
Tubes will be rapidly conditioned and samples stored at -80°C. After analysis, remaining samples will be stored in the Nîmes University Hospital Biological Collections.
15 patients selected from group T2 (the first 15); these patients will have 7 months of follow up during pregnancy.
Interventions to be administered: Bloodwork, Months -1 to -6
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| Blood work, Months 1 & 2 | Biological | 36 ml of blood are drawn at 1 & 2 months after inclusion in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146. |
|
| Bloodwork, Months -1 to -6 | Biological | 36 ml of blood are drawn at the third, fourth, fifth, sixth, seventh and eight months of normal pregnancy (corresponding to months -1 to -6 before comparative baseline; this group is included in the study early during pregnancy)in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146. |
|
For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth.
| baseline (day 0) |
| Leukocytes (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Polynuclear neutrophils(g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Mean corpuscular volume (fL) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Monocytes (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Mean corpuscular hemoglobin (pg/GR) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Lymphocytes (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Polynuclear eosinophils (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Polynuclear basophils (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| D-dimers (ng/ml) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Fibrin monomers (ng/ml) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Trophoblast microparticles (%) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Angiogenic marker CD146 (ng/ml) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | baseline (day 0) |
| Hemoglobin (g/l) | For group T1x only | 1 month |
| Platelets (g/l) | For group T1x only | 1 month |
| Leukocytes (g/l) | For group T1x only | 1 month |
| Polynuclear neutrophils(g/l) | For group T1x only | 1 month |
| Mean corpuscular volume (fL) | For group T1x only | 1 month |
| Monocytes (g/l) | For group T1x only | 1 month |
| Mean corpuscular hemoglobin (pg/GR) | For group T1x only | 1 month |
| Lymphocytes (g/l) | For group T1x only | 1 month |
| Polynuclear eosinophils (g/l) | For group T1x only | 1 month |
| Polynuclear basophils (g/l) | For group T1x only | 1 month |
| D-dimers (ng/ml) | For group T1x only | 1 month |
| Fibrin monomers (ng/ml) | For group T1x only | 1 month |
| Trophoblast microparticles (%) | For group T1x only | 1 month |
| Angiogenic marker CD146 (ng/ml) | For group T1x only | 1 month |
| Total plasma concentration of free DNA (ng/ml) | For group T1x only | 1 month |
| Total plasma concentration of nucleosomes (AU) | For group T1x only | 1 month |
| Hemoglobin (g/l) | For group T1x only | 2 months |
| Platelets (g/l) | For group T1x only | 2 months |
| Leukocytes (g/l) | For group T1x only | 2 months |
| Polynuclear neutrophils(g/l) | For group T1x only | 2 months |
| Mean corpuscular volume (fL) | For group T1x only | 2 months |
| Monocytes (g/l) | For group T1x only | 2 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T1x only | 2 months |
| Lymphocytes (g/l) | For group T1x only | 2 months |
| Polynuclear eosinophils (g/l) | For group T1x only | 2 months |
| Polynuclear basophils (g/l) | For group T1x only | 2 months |
| D-dimers (ng/ml) | For group T1x only | 2 months |
| Fibrin monomers (ng/ml) | For group T1x only | 2 months |
| Trophoblast microparticles (%) | For group T1x only | 2 months |
| Angiogenic marker CD146 (ng/ml) | For group T1x only | 2 months |
| Total plasma concentration of free DNA (ng/ml) | For group T1x only | 2 months |
| Total plasma concentration of nucleosomes (AU) | For group T1x only | 2 months |
| Hemoglobin (g/l) | For group T2x only | -1 months |
| Hemoglobin (g/l) | For group T2x only | -2 months |
| Hemoglobin (g/l) | For group T2x only | -3 months |
| Hemoglobin (g/l) | For group T2x only | -4 months |
| Hemoglobin (g/l) | For group T2x only | -5 months |
| Hemoglobin (g/l) | For group T2x only | -6 months |
| Platelets (g/l) | For group T2x only | -1 months |
| Platelets (g/l) | For group T2x only | -2 months |
| Platelets (g/l) | For group T2x only | -3 months |
| Platelets (g/l) | For group T2x only | -4 months |
| Platelets (g/l) | For group T2x only | -5 months |
| Platelets (g/l) | For group T2x only | -6 months |
| Leukocytes (g/l) | For group T2x only | -1 months |
| Leukocytes (g/l) | For group T2x only | -2 months |
| Leukocytes (g/l) | For group T2x only | -3 months |
| Leukocytes (g/l) | For group T2x only | -4 months |
| Leukocytes (g/l) | For group T2x only | -5 months |
| Leukocytes (g/l) | For group T2x only | -6 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -1 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -2 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -3 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -4 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -5 months |
| Polynuclear neutrophils(g/l) | For group T2x only | -6 months |
| Mean corpuscular volume (fL) | For group T2x only | -1 months |
| Mean corpuscular volume (fL) | For group T2x only | -2 months |
| Mean corpuscular volume (fL) | For group T2x only | -3 months |
| Mean corpuscular volume (fL) | For group T2x only | -4 months |
| Mean corpuscular volume (fL) | For group T2x only | -5 months |
| Mean corpuscular volume (fL) | For group T2x only | -6 months |
| Monocytes (g/l) | For group T2x only. | -1 months |
| Monocytes (g/l) | For group T2x only. | -2 months |
| Monocytes (g/l) | For group T2x only. | -3 months |
| Monocytes (g/l) | For group T2x only. | -4 months |
| Monocytes (g/l) | For group T2x only. | -5 months |
| Monocytes (g/l) | For group T2x only. | -6 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -1 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -2 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -3 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -4 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -5 months |
| Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -6 months |
| Lymphocytes (g/l) | For group T2x only. | -1 months |
| Lymphocytes (g/l) | For group T2x only. | -2 months |
| Lymphocytes (g/l) | For group T2x only. | -3 months |
| Lymphocytes (g/l) | For group T2x only. | -4 months |
| Lymphocytes (g/l) | For group T2x only. | -5 months |
| Lymphocytes (g/l) | For group T2x only. | -6 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -1 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -2 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -3 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -4 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -5 months |
| Polynuclear eosinophils (g/l) | For group T2x only. | -6 months |
| Polynuclear basophils (g/l) | For group T2x only. | -1 months |
| Polynuclear basophils (g/l) | For group T2x only. | -2 months |
| Polynuclear basophils (g/l) | For group T2x only. | -3 months |
| Polynuclear basophils (g/l) | For group T2x only. | -4 months |
| Polynuclear basophils (g/l) | For group T2x only. | -5 months |
| Polynuclear basophils (g/l) | For group T2x only. | -6 months |
| D-dimers (ng/ml) | For group T2x only. | -1 months |
| D-dimers (ng/ml) | For group T2x only. | -2 months |
| D-dimers (ng/ml) | For group T2x only. | -3 months |
| D-dimers (ng/ml) | For group T2x only. | -4 months |
| D-dimers (ng/ml) | For group T2x only. | -5 months |
| D-dimers (ng/ml) | For group T2x only. | -6 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -1 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -2 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -3 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -4 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -5 months |
| Fibrin monomers (ng/ml) | For group T2x only. | -6 months |
| Trophoblast microparticles (%) | For group T2x only. | -1 months |
| Trophoblast microparticles (%) | For group T2x only. | -2 months |
| Trophoblast microparticles (%) | For group T2x only. | -3 months |
| Trophoblast microparticles (%) | For group T2x only. | -4 months |
| Trophoblast microparticles (%) | For group T2x only. | -5 months |
| Trophoblast microparticles (%) | For group T2x only. | -6 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -1 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -2 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -3 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -4 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -5 months |
| Angiogenic marker CD146 (ng/ml) | For group T2x only. | -6 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -1 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -2 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -3 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -4 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -5 months |
| Total plasma concentration of nucleosomes (AU) | For group T2x only. | -6 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -1 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -2 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -3 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -4 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -5 months |
| Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -6 months |
| Fibrinogen (g/l) | For group P, baseline occurs within the 30 days preceding birth. For group T1, baseline = time of inclusion. For group T2, baseline occurs within the 30 days preceding birth. | Base line (day 0) |
| Fibrinogen (g/l) | For group T2x only. | -1 months |
| Fibrinogen (g/l) | For group T2x only. | -2 months |
| Fibrinogen (g/l) | For group T2x only. | -3 months |
| Fibrinogen (g/l) | For group T2x only. | -4 months |
| Fibrinogen (g/l) | For group T2x only. | -5 months |
| Fibrinogen (g/l) | For group T2x only. | -6 months |
| Bouvier S, Traboulsi W, Blois SM, Demattei C, Joshkon A, Mousty E, Nollet M, Paulmyer-Lacroix O, Foucault-Bertaud A, Fortier M, Leroyer AS, Bachelier R, Letouzey V, Alfaidy N, Dignat-George F, Blot-Chabaud M, Gris JC, Bardin N. Soluble CD146 is increased in preeclampsia and interacts with galectin-1 to regulate trophoblast migration through VEGFR2 receptor. F S Sci. 2022 Feb;3(1):84-94. doi: 10.1016/j.xfss.2021.11.002. Epub 2021 Nov 19. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D046110 | Hypertension, Pregnancy-Induced |
| D004461 | Eclampsia |
| D017359 | HELLP Syndrome |
| D011225 | Pre-Eclampsia |
| D005313 | Fetal Death |
| D010927 | Placental Insufficiency |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010922 | Placenta Diseases |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
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