Clinical Trial: Free DNA and Nucleosome Concentrations in Pathological Pregnancies
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies
Brief Summary:
The primary objective of this study is to demonstrate that plasma concentrations of nucleosomes and free DNA differ between three groups:
- pregnant patients with complications typical of placental insufficiency or venous thrombosis (group P),
- healthy women (Group T1) and
- healthy pregnant women (Group T2).
Detailed Summary:
Our secondary objectives include the following:
- To describe, in 15 healthy, non-pregnant women changes in plasma concentrations of nucleosomes and free DNA over 3 months.
- To describe, in 15 pregnant women (without complications), changes in plasma concentrations of nucleosomes and free DNA over the last 7 months of pregnancy
- To show that plasma concentrations of nucleosomes and free DNA, in patients with complicated pregnancies differ according to the nature of the complication
- To show that a relationship exists between the concentrations of nucleosomes, free DNA, and total granulocyte microparticles (and trophoblast particles for pregnant women)
- To evaluate the relationship between nucleosome concentrations, free DNA concentrations and circulating leukocyte populations
- To evaluate the relationship between nucleosome concentrations, free DNA concentrations and hemostasis markers
- To describe changes in hemostasis markers throughout pregnancy
- To evaluate the relationship between nucleosome concentrations, free DNA concentrations and the angiogenic marker CD146
- To add to the Nîmes University Hospital biological collections.
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome:
- Total plasma concentration of free DNA (ng/ml) [ Time Frame: 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) [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hemoglobin (g/l) [ Time Frame: 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) [ Time Frame: 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.
- Leukocytes (g/l) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 basophils (g/l) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 (%) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 1 month ]For group T1x only
- Platelets (g/l) [ Time Frame: 1 month ]For group T1x only
- Leukocytes (g/l) [ Time Frame: 1 month ]For group T1x only
- Polynuclear neutrophils(g/l) [ Time Frame: 1 month ]For group T1x only
- Mean corpuscular volume (fL) [ Time Frame: 1 month ]For group T1x only
- Monocytes (g/l) [ Time Frame: 1 month ]For group T1x only
- Mean corpuscular hemoglobin (pg/GR) [ Time Frame: 1 month ]For group T1x only
- Lymphocytes (g/l) [ Time
Original Secondary Outcome:
- Hemoglobin (g/l) [ Time Frame: 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) [ Time Frame: 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.
- Leukocytes (g/l) [ Time Frame: 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) [ Time Frame: 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 (µ^3) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 basophils (g/l) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 (%) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 1 month ]For group T1x only
- Platelets (g/l) [ Time Frame: 1 month ]For group T1x only
- Leukocytes (g/l) [ Time Frame: 1 month ]For group T1x only
- Polynuclear neutrophils(g/l) [ Time Frame: 1 month ]For group T1x only
- Mean corpuscular volume (µ^3) [ Time Frame: 1 month ]For group T1x only
- Monocytes (g/l) [ Time Frame: 1 month ]For group T1x only
- Mean corpuscular hemoglobin (pg/GR) [ Time Frame: 1 month ]For group T1x only
- Lymphocytes (g/l)
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: November 27, 2012
Date Started: June 2015
Date Completion: December 2018
Last Updated: October 24, 2016
Last Verified: October 2016
- Hemoglobin (g/l) [ Time Frame: baseline (day 0) ]