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Free DNA and Nucleosome Concentrations in Pathological Pregnancies

10. ledna 2019 aktualizováno: Centre Hospitalier Universitaire de Nīmes

Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies

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).

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

137

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Nîmes Cedex 9, Francie, 30029
        • CHU de Nîmes - Hôpital Universitaire Carémeau

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

  • The first 15 patients from group T1 will form group T1x. The latter group has two months of additional follow up.

Group T2: 50 pregnant, healthy volunteers

  • The first 15 patients from group T2 will form group T2x. The latter group has 7 months of follow-up during pregnancy.

Popis

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)

Exclusion Criteria for group P:

  • Twin or multiple pregnancy
  • The patient is participating in another study (with the exception of those mentioned in the exclusion criteria for all patients and the DG Postpartum study (2013-A00277-38)

Exclusion Criteria for group T1:

  • 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)

Exclusion Criteria for group T2:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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

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

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

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

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.
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

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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total plasma concentration of free DNA (ng/ml)
Časové okno: 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.
Base line (day 0)
Total plasma concentration of nucleosomes (AU)
Časové okno: 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
Base line (day 0)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hemoglobin (g/l)
Časové okno: 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.
baseline (day 0)
Platelets (g/l)
Časové okno: 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.
baseline (day 0)
Leukocytes (g/l)
Časové okno: 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.
baseline (day 0)
Polynuclear neutrophils(g/l)
Časové okno: 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.
baseline (day 0)
Mean corpuscular volume (fL)
Časové okno: 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.
baseline (day 0)
Monocytes (g/l)
Časové okno: 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.
baseline (day 0)
Mean corpuscular hemoglobin (pg/GR)
Časové okno: 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.
baseline (day 0)
Lymphocytes (g/l)
Časové okno: 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.
baseline (day 0)
Polynuclear eosinophils (g/l)
Časové okno: 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.
baseline (day 0)
Polynuclear basophils (g/l)
Časové okno: 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.
baseline (day 0)
D-dimers (ng/ml)
Časové okno: 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.
baseline (day 0)
Fibrin monomers (ng/ml)
Časové okno: 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.
baseline (day 0)
Trophoblast microparticles (%)
Časové okno: 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.
baseline (day 0)
Angiogenic marker CD146 (ng/ml)
Časové okno: 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.
baseline (day 0)
Hemoglobin (g/l)
Časové okno: 1 month
For group T1x only
1 month
Platelets (g/l)
Časové okno: 1 month
For group T1x only
1 month
Leukocytes (g/l)
Časové okno: 1 month
For group T1x only
1 month
Polynuclear neutrophils(g/l)
Časové okno: 1 month
For group T1x only
1 month
Mean corpuscular volume (fL)
Časové okno: 1 month
For group T1x only
1 month
Monocytes (g/l)
Časové okno: 1 month
For group T1x only
1 month
Mean corpuscular hemoglobin (pg/GR)
Časové okno: 1 month
For group T1x only
1 month
Lymphocytes (g/l)
Časové okno: 1 month
For group T1x only
1 month
Polynuclear eosinophils (g/l)
Časové okno: 1 month
For group T1x only
1 month
Polynuclear basophils (g/l)
Časové okno: 1 month
For group T1x only
1 month
D-dimers (ng/ml)
Časové okno: 1 month
For group T1x only
1 month
Fibrin monomers (ng/ml)
Časové okno: 1 month
For group T1x only
1 month
Trophoblast microparticles (%)
Časové okno: 1 month
For group T1x only
1 month
Angiogenic marker CD146 (ng/ml)
Časové okno: 1 month
For group T1x only
1 month
Total plasma concentration of free DNA (ng/ml)
Časové okno: 1 month
For group T1x only
1 month
Total plasma concentration of nucleosomes (AU)
Časové okno: 1 month
For group T1x only
1 month
Hemoglobin (g/l)
Časové okno: 2 months
For group T1x only
2 months
Platelets (g/l)
Časové okno: 2 months
For group T1x only
2 months
Leukocytes (g/l)
Časové okno: 2 months
For group T1x only
2 months
Polynuclear neutrophils(g/l)
Časové okno: 2 months
For group T1x only
2 months
Mean corpuscular volume (fL)
Časové okno: 2 months
For group T1x only
2 months
Monocytes (g/l)
Časové okno: 2 months
For group T1x only
2 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: 2 months
For group T1x only
2 months
Lymphocytes (g/l)
Časové okno: 2 months
For group T1x only
2 months
Polynuclear eosinophils (g/l)
Časové okno: 2 months
For group T1x only
2 months
Polynuclear basophils (g/l)
Časové okno: 2 months
For group T1x only
2 months
D-dimers (ng/ml)
Časové okno: 2 months
For group T1x only
2 months
Fibrin monomers (ng/ml)
Časové okno: 2 months
For group T1x only
2 months
Trophoblast microparticles (%)
Časové okno: 2 months
For group T1x only
2 months
Angiogenic marker CD146 (ng/ml)
Časové okno: 2 months
For group T1x only
2 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: 2 months
For group T1x only
2 months
Total plasma concentration of nucleosomes (AU)
Časové okno: 2 months
For group T1x only
2 months
Hemoglobin (g/l)
Časové okno: -1 months
For group T2x only
-1 months
Hemoglobin (g/l)
Časové okno: -2 months
For group T2x only
-2 months
Hemoglobin (g/l)
Časové okno: -3 months
For group T2x only
-3 months
Hemoglobin (g/l)
Časové okno: -4 months
For group T2x only
-4 months
Hemoglobin (g/l)
Časové okno: -5 months
For group T2x only
-5 months
Hemoglobin (g/l)
Časové okno: -6 months
For group T2x only
-6 months
Platelets (g/l)
Časové okno: -1 months
For group T2x only
-1 months
Platelets (g/l)
Časové okno: -2 months
For group T2x only
-2 months
Platelets (g/l)
Časové okno: -3 months
For group T2x only
-3 months
Platelets (g/l)
Časové okno: -4 months
For group T2x only
-4 months
Platelets (g/l)
Časové okno: -5 months
For group T2x only
-5 months
Platelets (g/l)
Časové okno: -6 months
For group T2x only
-6 months
Leukocytes (g/l)
Časové okno: -1 months
For group T2x only
-1 months
Leukocytes (g/l)
Časové okno: -2 months
For group T2x only
-2 months
Leukocytes (g/l)
Časové okno: -3 months
For group T2x only
-3 months
Leukocytes (g/l)
Časové okno: -4 months
For group T2x only
-4 months
Leukocytes (g/l)
Časové okno: -5 months
For group T2x only
-5 months
Leukocytes (g/l)
Časové okno: -6 months
For group T2x only
-6 months
Polynuclear neutrophils(g/l)
Časové okno: -1 months
For group T2x only
-1 months
Polynuclear neutrophils(g/l)
Časové okno: -2 months
For group T2x only
-2 months
Polynuclear neutrophils(g/l)
Časové okno: -3 months
For group T2x only
-3 months
Polynuclear neutrophils(g/l)
Časové okno: -4 months
For group T2x only
-4 months
Polynuclear neutrophils(g/l)
Časové okno: -5 months
For group T2x only
-5 months
Polynuclear neutrophils(g/l)
Časové okno: -6 months
For group T2x only
-6 months
Mean corpuscular volume (fL)
Časové okno: -1 months
For group T2x only
-1 months
Mean corpuscular volume (fL)
Časové okno: -2 months
For group T2x only
-2 months
Mean corpuscular volume (fL)
Časové okno: -3 months
For group T2x only
-3 months
Mean corpuscular volume (fL)
Časové okno: -4 months
For group T2x only
-4 months
Mean corpuscular volume (fL)
Časové okno: -5 months
For group T2x only
-5 months
Mean corpuscular volume (fL)
Časové okno: -6 months
For group T2x only
-6 months
Monocytes (g/l)
Časové okno: -1 months
For group T2x only.
-1 months
Monocytes (g/l)
Časové okno: -2 months
For group T2x only.
-2 months
Monocytes (g/l)
Časové okno: -3 months
For group T2x only.
-3 months
Monocytes (g/l)
Časové okno: -4 months
For group T2x only.
-4 months
Monocytes (g/l)
Časové okno: -5 months
For group T2x only.
-5 months
Monocytes (g/l)
Časové okno: -6 months
For group T2x only.
-6 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -1 months
For group T2x only.
-1 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -2 months
For group T2x only.
-2 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -3 months
For group T2x only.
-3 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -4 months
For group T2x only.
-4 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -5 months
For group T2x only.
-5 months
Mean corpuscular hemoglobin (pg/GR)
Časové okno: -6 months
For group T2x only.
-6 months
Lymphocytes (g/l)
Časové okno: -1 months
For group T2x only.
-1 months
Lymphocytes (g/l)
Časové okno: -2 months
For group T2x only.
-2 months
Lymphocytes (g/l)
Časové okno: -3 months
For group T2x only.
-3 months
Lymphocytes (g/l)
Časové okno: -4 months
For group T2x only.
-4 months
Lymphocytes (g/l)
Časové okno: -5 months
For group T2x only.
-5 months
Lymphocytes (g/l)
Časové okno: -6 months
For group T2x only.
-6 months
Polynuclear eosinophils (g/l)
Časové okno: -1 months
For group T2x only.
-1 months
Polynuclear eosinophils (g/l)
Časové okno: -2 months
For group T2x only.
-2 months
Polynuclear eosinophils (g/l)
Časové okno: -3 months
For group T2x only.
-3 months
Polynuclear eosinophils (g/l)
Časové okno: -4 months
For group T2x only.
-4 months
Polynuclear eosinophils (g/l)
Časové okno: -5 months
For group T2x only.
-5 months
Polynuclear eosinophils (g/l)
Časové okno: -6 months
For group T2x only.
-6 months
Polynuclear basophils (g/l)
Časové okno: -1 months
For group T2x only.
-1 months
Polynuclear basophils (g/l)
Časové okno: -2 months
For group T2x only.
-2 months
Polynuclear basophils (g/l)
Časové okno: -3 months
For group T2x only.
-3 months
Polynuclear basophils (g/l)
Časové okno: -4 months
For group T2x only.
-4 months
Polynuclear basophils (g/l)
Časové okno: -5 months
For group T2x only.
-5 months
Polynuclear basophils (g/l)
Časové okno: -6 months
For group T2x only.
-6 months
D-dimers (ng/ml)
Časové okno: -1 months
For group T2x only.
-1 months
D-dimers (ng/ml)
Časové okno: -2 months
For group T2x only.
-2 months
D-dimers (ng/ml)
Časové okno: -3 months
For group T2x only.
-3 months
D-dimers (ng/ml)
Časové okno: -4 months
For group T2x only.
-4 months
D-dimers (ng/ml)
Časové okno: -5 months
For group T2x only.
-5 months
D-dimers (ng/ml)
Časové okno: -6 months
For group T2x only.
-6 months
Fibrin monomers (ng/ml)
Časové okno: -1 months
For group T2x only.
-1 months
Fibrin monomers (ng/ml)
Časové okno: -2 months
For group T2x only.
-2 months
Fibrin monomers (ng/ml)
Časové okno: -3 months
For group T2x only.
-3 months
Fibrin monomers (ng/ml)
Časové okno: -4 months
For group T2x only.
-4 months
Fibrin monomers (ng/ml)
Časové okno: -5 months
For group T2x only.
-5 months
Fibrin monomers (ng/ml)
Časové okno: -6 months
For group T2x only.
-6 months
Trophoblast microparticles (%)
Časové okno: -1 months
For group T2x only.
-1 months
Trophoblast microparticles (%)
Časové okno: -2 months
For group T2x only.
-2 months
Trophoblast microparticles (%)
Časové okno: -3 months
For group T2x only.
-3 months
Trophoblast microparticles (%)
Časové okno: -4 months
For group T2x only.
-4 months
Trophoblast microparticles (%)
Časové okno: -5 months
For group T2x only.
-5 months
Trophoblast microparticles (%)
Časové okno: -6 months
For group T2x only.
-6 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -1 months
For group T2x only.
-1 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -2 months
For group T2x only.
-2 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -3 months
For group T2x only.
-3 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -4 months
For group T2x only.
-4 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -5 months
For group T2x only.
-5 months
Angiogenic marker CD146 (ng/ml)
Časové okno: -6 months
For group T2x only.
-6 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -1 months
For group T2x only.
-1 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -2 months
For group T2x only.
-2 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -3 months
For group T2x only.
-3 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -4 months
For group T2x only.
-4 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -5 months
For group T2x only.
-5 months
Total plasma concentration of nucleosomes (AU)
Časové okno: -6 months
For group T2x only.
-6 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -1 months
For group T2x only.
-1 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -2 months
For group T2x only.
-2 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -3 months
For group T2x only.
-3 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -4 months
For group T2x only.
-4 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -5 months
For group T2x only.
-5 months
Total plasma concentration of free DNA (ng/ml)
Časové okno: -6 months
For group T2x only.
-6 months
Fibrinogen (g/l)
Časové okno: 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.
Base line (day 0)
Fibrinogen (g/l)
Časové okno: -1 months
For group T2x only.
-1 months
Fibrinogen (g/l)
Časové okno: -2 months
For group T2x only.
-2 months
Fibrinogen (g/l)
Časové okno: -3 months
For group T2x only.
-3 months
Fibrinogen (g/l)
Časové okno: -4 months
For group T2x only.
-4 months
Fibrinogen (g/l)
Časové okno: -5 months
For group T2x only.
-5 months
Fibrinogen (g/l)
Časové okno: -6 months
For group T2x only.
-6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Sylvie Bouvier, MD, Centre Hospitalier Universitaire de Nîmes
  • Vrchní vyšetřovatel: Eve Mousty, MD, Centre Hospitalier Universitaire de Nîmes

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2015

Primární dokončení (Aktuální)

17. prosince 2018

Dokončení studie (Aktuální)

17. prosince 2018

Termíny zápisu do studia

První předloženo

27. listopadu 2012

První předloženo, které splnilo kritéria kontroly kvality

27. listopadu 2012

První zveřejněno (Odhad)

29. listopadu 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. ledna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. ledna 2019

Naposledy ověřeno

1. ledna 2019

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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