Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies
18 Years
N/A
Female
Pregnancy, Venous Thrombosis, Pulmonary Embolism, Hypertension, Pregnancy-Induced, Eclampsia, HELLP Syndrome, Pre-Eclampsia, Fetal Death, Placental Insufficiency
Trial Information
Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies
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.
Inclusion Criteria
Inclusion Criteria for all patients:
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
Inclusion Criteria for patients in group P:
- 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)
Inclusion Criteria for patients in group T1:
- The patient is available for 3 months of follow-up
- The patient is a non-pregnant healthy volunteer
- No identifiable chronic pathologies
- No history of neoplastic disease
- No history of chronic infectious disease
- No acute disease (such as benign infection), now or within the past two weeks
Inclusion Criteria for patients in group T2:
- The patient is available for 7 months of follow-up
- The patient is pregnant, with no identifiable pregnancy complications
- No identifiable chronic pathologies
- No history of neoplastic disease
- No history of chronic infectious disease
- No acute disease (such as benign infection), now or within the past two weeks
Exclusion Criteria for all patients:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient cannot read French
- The patient is receiving hormonal ovarian stimulation in the context of medically
assisted procreation
- Impossible to perform venipuncture under good conditions
- New complication or pathology during the study (except for pregnancy complications in
group P)
Exclusion Criteria for group T1:
- The patient is pregnant
- The patient is breast feeding
- The patient has given birth within the last 3 months
- Known history of chronic disease
- History of treated neoplastic disease
- Acute disease within the past two weeks (includes benign disease)
Exclusion Criteria for group T2:
- Pregnancy with complications
- Known history of chronic disease
- History of treated neoplastic disease
- Acute disease within the past two weeks (includes benign disease)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Total plasma concentration of free DNA (ng/ml)
Outcome Description:
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.
Outcome Time Frame:
Base line (day 0)
Safety Issue:
No
Principal Investigator
Sylvie Bouvier, MD
Investigator Role:
Study Director
Investigator Affiliation:
Centre Hospitalier Universitaire de Nîmes
Authority:
France: Committee for the Protection of Personnes
Study ID:
LOCAL/2012/SB-01
NCT ID:
NCT01736826
Start Date:
September 2013
Completion Date:
October 2016
Related Keywords:
- Pregnancy
- Venous Thrombosis
- Pulmonary Embolism
- Hypertension, Pregnancy-Induced
- Eclampsia
- HELLP Syndrome
- Pre-Eclampsia
- Fetal Death
- Placental Insufficiency
- plasma nucleosome concentration
- plasma free DNA concentration
- Eclampsia
- Embolism
- Fetal Death
- Hypertension
- Placental Insufficiency
- Pre-Eclampsia
- Pulmonary Embolism
- Thrombosis
- Venous Thrombosis
- Venous Thromboembolism
- HELLP Syndrome
- Hypertension, Pregnancy-Induced
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