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:

  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 Summary:

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.

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