Eclampsia, Fetal Death, HELLP Syndrome, Hypertension, Pregnancy-Induced, Placental Insufficiency, Pre-Eclampsia, Pregnancy, Pulmonary Embolism, Venous Thrombosis
Conditions
Keywords
plasma nucleosome concentration, plasma free DNA concentration
Brief summary
The primary objective of this study is to demonstrate that plasma concentrations of nucleosomes and free DNA differ between three groups: 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).
Detailed description
Our secondary objectives include the following: 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.
Interventions
BIOLOGICALBloodwork, 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.
BIOLOGICALBlood 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.
BIOLOGICALBloodwork, 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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for all patients: * The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan Inclusion Criteria for patients in group P: * 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) Inclusion Criteria for patients in group T1: * 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 Inclusion Criteria for patients in group T2: * 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
for all patients: * The patient is participating in another study (with the exception of the following studies: PAPILLO-PMA (2013-A00538-37), ElastoMAP (2013-A01148-37), ElastoDéclenche (2014-A00828-39), LXRs (2009-A00968-49), Bakri (2013-A00914-41), OASIS 2 (2013-A00022-43)). * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total plasma concentration of free DNA (ng/ml) | Base line (day 0) | 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. |
| Total plasma concentration of nucleosomes (AU) | Base line (day 0) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukocytes (g/l) | baseline (day 0) | 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. |
| Polynuclear neutrophils(g/l) | baseline (day 0) | 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. |
| Mean corpuscular volume (fL) | baseline (day 0) | 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. |
| Monocytes (g/l) | baseline (day 0) | 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. |
| Mean corpuscular hemoglobin (pg/GR) | baseline (day 0) | 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. |
| Lymphocytes (g/l) | baseline (day 0) | 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. |
| Polynuclear eosinophils (g/l) | baseline (day 0) | 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. |
| Hemoglobin (g/l) | baseline (day 0) | 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. |
| D-dimers (ng/ml) | baseline (day 0) | 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. |
| Fibrin monomers (ng/ml) | baseline (day 0) | 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. |
| Trophoblast microparticles (%) | baseline (day 0) | 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. |
| Angiogenic marker CD146 (ng/ml) | baseline (day 0) | 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. |
| Total plasma concentration of free DNA (ng/ml) | 1 month | For group T1x only |
| Total plasma concentration of nucleosomes (AU) | 1 month | For group T1x only |
| Fibrinogen (g/l) | Base line (day 0) | 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. |
| Polynuclear basophils (g/l) | baseline (day 0) | 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. |
| Platelets (g/l) | baseline (day 0) | 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. |
Countries
France
Outcome results
None listed