Pregnancy Clinical Trial
Official title:
Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies
Verified date | January 2019 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 137 |
Est. completion date | December 17, 2018 |
Est. primary completion date | December 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Secondary | 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) | |
Secondary | Platelets (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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Hemoglobin (g/l) | For group T1x only | 1 month | |
Secondary | Platelets (g/l) | For group T1x only | 1 month | |
Secondary | Leukocytes (g/l) | For group T1x only | 1 month | |
Secondary | Polynuclear neutrophils(g/l) | For group T1x only | 1 month | |
Secondary | Mean corpuscular volume (fL) | For group T1x only | 1 month | |
Secondary | Monocytes (g/l) | For group T1x only | 1 month | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T1x only | 1 month | |
Secondary | Lymphocytes (g/l) | For group T1x only | 1 month | |
Secondary | Polynuclear eosinophils (g/l) | For group T1x only | 1 month | |
Secondary | Polynuclear basophils (g/l) | For group T1x only | 1 month | |
Secondary | D-dimers (ng/ml) | For group T1x only | 1 month | |
Secondary | Fibrin monomers (ng/ml) | For group T1x only | 1 month | |
Secondary | Trophoblast microparticles (%) | For group T1x only | 1 month | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T1x only | 1 month | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T1x only | 1 month | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T1x only | 1 month | |
Secondary | Hemoglobin (g/l) | For group T1x only | 2 months | |
Secondary | Platelets (g/l) | For group T1x only | 2 months | |
Secondary | Leukocytes (g/l) | For group T1x only | 2 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T1x only | 2 months | |
Secondary | Mean corpuscular volume (fL) | For group T1x only | 2 months | |
Secondary | Monocytes (g/l) | For group T1x only | 2 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T1x only | 2 months | |
Secondary | Lymphocytes (g/l) | For group T1x only | 2 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T1x only | 2 months | |
Secondary | Polynuclear basophils (g/l) | For group T1x only | 2 months | |
Secondary | D-dimers (ng/ml) | For group T1x only | 2 months | |
Secondary | Fibrin monomers (ng/ml) | For group T1x only | 2 months | |
Secondary | Trophoblast microparticles (%) | For group T1x only | 2 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T1x only | 2 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T1x only | 2 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T1x only | 2 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -1 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -2 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -3 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -4 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -5 months | |
Secondary | Hemoglobin (g/l) | For group T2x only | -6 months | |
Secondary | Platelets (g/l) | For group T2x only | -1 months | |
Secondary | Platelets (g/l) | For group T2x only | -2 months | |
Secondary | Platelets (g/l) | For group T2x only | -3 months | |
Secondary | Platelets (g/l) | For group T2x only | -4 months | |
Secondary | Platelets (g/l) | For group T2x only | -5 months | |
Secondary | Platelets (g/l) | For group T2x only | -6 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -1 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -2 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -3 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -4 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -5 months | |
Secondary | Leukocytes (g/l) | For group T2x only | -6 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -1 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -2 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -3 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -4 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -5 months | |
Secondary | Polynuclear neutrophils(g/l) | For group T2x only | -6 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -1 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -2 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -3 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -4 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -5 months | |
Secondary | Mean corpuscular volume (fL) | For group T2x only | -6 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -1 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -2 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -3 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -4 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -5 months | |
Secondary | Monocytes (g/l) | For group T2x only. | -6 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -1 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -2 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -3 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -4 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -5 months | |
Secondary | Mean corpuscular hemoglobin (pg/GR) | For group T2x only. | -6 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -1 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -2 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -3 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -4 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -5 months | |
Secondary | Lymphocytes (g/l) | For group T2x only. | -6 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -1 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -2 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -3 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -4 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -5 months | |
Secondary | Polynuclear eosinophils (g/l) | For group T2x only. | -6 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -1 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -2 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -3 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -4 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -5 months | |
Secondary | Polynuclear basophils (g/l) | For group T2x only. | -6 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -1 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -2 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -3 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -4 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -5 months | |
Secondary | D-dimers (ng/ml) | For group T2x only. | -6 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -1 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -2 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -3 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -4 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -5 months | |
Secondary | Fibrin monomers (ng/ml) | For group T2x only. | -6 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -1 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -2 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -3 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -4 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -5 months | |
Secondary | Trophoblast microparticles (%) | For group T2x only. | -6 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -1 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -2 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -3 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -4 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -5 months | |
Secondary | Angiogenic marker CD146 (ng/ml) | For group T2x only. | -6 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -1 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -2 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -3 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -4 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -5 months | |
Secondary | Total plasma concentration of nucleosomes (AU) | For group T2x only. | -6 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -1 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -2 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -3 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -4 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -5 months | |
Secondary | Total plasma concentration of free DNA (ng/ml) | For group T2x only. | -6 months | |
Secondary | 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) | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -1 months | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -2 months | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -3 months | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -4 months | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -5 months | |
Secondary | Fibrinogen (g/l) | For group T2x only. | -6 months |
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