Free DNA and Nucleosome Concentrations in Pathological Pregnancies

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).

Conditions

• Pregnancy
• Venous Thrombosis
• Pulmonary Embolism
• Hypertension, Pregnancy-Induced
• Eclampsia
• HELLP Syndrome
• Pre-Eclampsia
• Fetal Death
• Placental Insufficiency

Interventions

BIOLOGICAL

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.

BIOLOGICAL

Blood 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.

BIOLOGICAL

Bloodwork, 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 & Collaborators

• Centre Hospitalier Universitaire de Nīmes

  lead OTHER

Principal Investigators

• Sylvie Bouvier, MD · Centre Hospitalier Universitaire de Nîmes

• Eve Mousty, MD · Centre Hospitalier Universitaire de Nîmes

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-12-11

Completion

2017-12-11

Countries

• France

Study Locations