Free DNA and Nucleosome Concentrations in Pathological Pregnancies
NCT ID: NCT01736826
Last Updated: 2025-11-21
Study Results
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Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2015-06-30
2017-12-11
Brief Summary
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1. pregnant patients with complications typical of placental insufficiency or venous thrombosis (group P),
2. healthy women (Group T1) and
3. healthy pregnant women (Group T2).
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Detailed Description
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1. To describe, in 15 healthy, non-pregnant women changes in plasma concentrations of nucleosomes and free DNA over 3 months.
2. To describe, in 15 pregnant women (without complications), changes in plasma concentrations of nucleosomes and free DNA over the last 7 months of pregnancy
3. To show that plasma concentrations of nucleosomes and free DNA, in patients with complicated pregnancies differ according to the nature of the complication
4. To show that a relationship exists between the concentrations of nucleosomes, free DNA, and total granulocyte microparticles (and trophoblast particles for pregnant women)
5. To evaluate the relationship between nucleosome concentrations, free DNA concentrations and circulating leukocyte populations
6. To evaluate the relationship between nucleosome concentrations, free DNA concentrations and hemostasis markers
7. To describe changes in hemostasis markers throughout pregnancy
8. To evaluate the relationship between nucleosome concentrations, free DNA concentrations and the angiogenic marker CD146
9. To add to the Nîmes University Hospital biological collections.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Bloodwork, baseline
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.
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
Bloodwork, baseline
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.
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
Bloodwork, baseline
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.
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
Bloodwork, baseline
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.
Blood work, Months 1 & 2
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.
Group T2x: 15 Pregnancy, no complications
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
Bloodwork, baseline
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.
Bloodwork, Months -1 to -6
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.
Interventions
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Bloodwork, baseline
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.
Blood work, Months 1 & 2
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
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.
Eligibility Criteria
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Inclusion Criteria
* The patient must be insured or beneficiary of a health insurance plan
* 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)
* The patient is available for 3 months of follow-up
* The patient is a non-pregnant healthy volunteer
* No identifiable chronic pathologies
* No history of neoplastic disease
* No history of chronic infectious disease
* No acute disease (such as benign infection), now or within the past two weeks
* The patient is available for 7 months of follow-up
* The patient is pregnant, with no identifiable pregnancy complications
* No identifiable chronic pathologies
* No history of neoplastic disease
* No history of chronic infectious disease
* No acute disease (such as benign infection), now or within the past two weeks
Exclusion Criteria
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient is receiving hormonal ovarian stimulation in the context of medically assisted procreation
* Impossible to perform venipuncture under good conditions
* New complication or pathology during the study (except for pregnancy complications in group P)
* Twin or multiple pregnancy
* The patient is pregnant
* The patient is breast feeding
* The patient has given birth within the last 3 months
* Known history of chronic disease
* History of treated neoplastic disease
* Acute disease within the past two weeks (includes benign disease)
* Pregnancy with complications
* Known history of chronic disease
* History of treated neoplastic disease
* Acute disease within the past two weeks (includes benign disease)
* Twin or multiple pregnancy
18 Years
FEMALE
Yes
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Sylvie Bouvier, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Eve Mousty, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
Countries
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References
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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.
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.
Other Identifiers
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2014-A01120-47
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2012/SB-01
Identifier Type: -
Identifier Source: org_study_id
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