NCT01736826

Free DNA and Nucleosome Concentrations in Pathological Pregnancies

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 137 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2012-11-29
• Last updated: 2025-11-21

Locations

1 site across 1 country: France