Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Total plasma concentration of nucleosomes (AU)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group P: pregnancy w/complications
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).
100 patients will be included.
Interventions to be administered: Bloodwork, baseline
干预措施: Bloodwork, baseline (Biological)
Group T1: Healthy volunteers
Healthy volunteers with no history of chronic or neoplastic disease.
30 healthy volunteers will be included.
Interventions to be administered: Bloodwork, baseline
干预措施: Bloodwork, baseline (Biological)
Group T2: Pregnancy, no complications
Pregnant patients with no identifiable pregnancy complications, and no history of chronic or neoplastic disease.
50 pregnant volunteers will be included.
Interventions to be administered: Bloodwork, baseline
干预措施: Bloodwork, baseline (Biological)
Group T1x: 15 Healthy volunteers
15 Healthy volunteers selected from group T1 (the first 15). These patients will have 2 additional months of follow up.
Interventions to be administered: Blood work, Months 1 & 2
干预措施: Bloodwork, baseline (Biological)
Group T1x: 15 Healthy volunteers
15 Healthy volunteers selected from group T1 (the first 15). These patients will have 2 additional months of follow up.
Interventions to be administered: Blood work, Months 1 & 2
干预措施: Blood work, Months 1 & 2 (Biological)
Group T2x: 15 Pregnancy, no complications
15 patients selected from group T2 (the first 15); these patients will have 7 months of follow up during pregnancy.
Interventions to be administered: Bloodwork, Months -1 to -6
干预措施: Bloodwork, baseline (Biological)
Group T2x: 15 Pregnancy, no complications
15 patients selected from group T2 (the first 15); these patients will have 7 months of follow up during pregnancy.
Interventions to be administered: Bloodwork, Months -1 to -6
干预措施: Bloodwork, Months -1 to -6 (Biological)
结局指标
主要结局
Total plasma concentration of nucleosomes (AU)
时间窗: 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 free DNA (ng/ml)
时间窗: 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.
次要结局
- Monocytes (g/l)(-6 months)
- Lymphocytes (g/l)(-6 months)
- Hemoglobin (g/l)(-6 months)
- Platelets (g/l)(-6 months)
- Leukocytes (g/l)(-6 months)
- Polynuclear neutrophils(g/l)(-6 months)
- Mean corpuscular volume (fL)(-6 months)
- Mean corpuscular hemoglobin (pg/GR)(-6 months)
- Polynuclear eosinophils (g/l)(-6 months)
- Polynuclear basophils (g/l)(-6 months)
- D-dimers (ng/ml)(-6 months)
- Fibrin monomers (ng/ml)(-6 months)
- Trophoblast microparticles (%)(-6 months)
- Total plasma concentration of free DNA (ng/ml)(-6 months)
- Total plasma concentration of nucleosomes (AU)(-6 months)
- Fibrinogen (g/l)(-6 months)
- Angiogenic marker CD146 (ng/ml)(-6 months)