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Free DNA and Nucleosome Concentrations in Pathological Pregnancies

2019년 1월 10일 업데이트: Centre Hospitalier Universitaire de Nīmes

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

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).

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

137

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Nîmes Cedex 9, 프랑스, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

The study population includes three groups:

Group P: 100 pregnant women with complications typical of placental vascular disease or venous thromboembolism.

Group T1: 30 non-pregnant, healthy volunteers

  • The first 15 patients from group T1 will form group T1x. The latter group has two months of additional follow up.

Group T2: 50 pregnant, healthy volunteers

  • The first 15 patients from group T2 will form group T2x. The latter group has 7 months of follow-up during pregnancy.

설명

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 (with the exception of the following studies: PAPILLO-PMA (2013-A00538-37), ElastoMAP (2013-A01148-37), ElastoDéclenche (2014-A00828-39), LXRs (2009-A00968-49), Bakri (2013-A00914-41), OASIS 2 (2013-A00022-43)).
  • 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 P:

  • Twin or multiple pregnancy
  • The patient is participating in another study (with the exception of those mentioned in the exclusion criteria for all patients and the DG Postpartum study (2013-A00277-38)

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)
  • Twin or multiple pregnancy

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
개입 / 치료
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

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.
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

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.
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

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.
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

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.
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.
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

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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total plasma concentration of free DNA (ng/ml)
기간: 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.
Base line (day 0)
Total plasma concentration of nucleosomes (AU)
기간: 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
Base line (day 0)

2차 결과 측정

결과 측정
측정값 설명
기간
Hemoglobin (g/l)
기간: 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.
baseline (day 0)
Platelets (g/l)
기간: 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.
baseline (day 0)
Leukocytes (g/l)
기간: 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.
baseline (day 0)
Polynuclear neutrophils(g/l)
기간: 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.
baseline (day 0)
Mean corpuscular volume (fL)
기간: 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.
baseline (day 0)
Monocytes (g/l)
기간: 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.
baseline (day 0)
Mean corpuscular hemoglobin (pg/GR)
기간: 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.
baseline (day 0)
Lymphocytes (g/l)
기간: 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.
baseline (day 0)
Polynuclear eosinophils (g/l)
기간: 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.
baseline (day 0)
Polynuclear basophils (g/l)
기간: 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.
baseline (day 0)
D-dimers (ng/ml)
기간: 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.
baseline (day 0)
Fibrin monomers (ng/ml)
기간: 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.
baseline (day 0)
Trophoblast microparticles (%)
기간: 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.
baseline (day 0)
Angiogenic marker CD146 (ng/ml)
기간: 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.
baseline (day 0)
Hemoglobin (g/l)
기간: 1 month
For group T1x only
1 month
Platelets (g/l)
기간: 1 month
For group T1x only
1 month
Leukocytes (g/l)
기간: 1 month
For group T1x only
1 month
Polynuclear neutrophils(g/l)
기간: 1 month
For group T1x only
1 month
Mean corpuscular volume (fL)
기간: 1 month
For group T1x only
1 month
Monocytes (g/l)
기간: 1 month
For group T1x only
1 month
Mean corpuscular hemoglobin (pg/GR)
기간: 1 month
For group T1x only
1 month
Lymphocytes (g/l)
기간: 1 month
For group T1x only
1 month
Polynuclear eosinophils (g/l)
기간: 1 month
For group T1x only
1 month
Polynuclear basophils (g/l)
기간: 1 month
For group T1x only
1 month
D-dimers (ng/ml)
기간: 1 month
For group T1x only
1 month
Fibrin monomers (ng/ml)
기간: 1 month
For group T1x only
1 month
Trophoblast microparticles (%)
기간: 1 month
For group T1x only
1 month
Angiogenic marker CD146 (ng/ml)
기간: 1 month
For group T1x only
1 month
Total plasma concentration of free DNA (ng/ml)
기간: 1 month
For group T1x only
1 month
Total plasma concentration of nucleosomes (AU)
기간: 1 month
For group T1x only
1 month
Hemoglobin (g/l)
기간: 2 months
For group T1x only
2 months
Platelets (g/l)
기간: 2 months
For group T1x only
2 months
Leukocytes (g/l)
기간: 2 months
For group T1x only
2 months
Polynuclear neutrophils(g/l)
기간: 2 months
For group T1x only
2 months
Mean corpuscular volume (fL)
기간: 2 months
For group T1x only
2 months
Monocytes (g/l)
기간: 2 months
For group T1x only
2 months
Mean corpuscular hemoglobin (pg/GR)
기간: 2 months
For group T1x only
2 months
Lymphocytes (g/l)
기간: 2 months
For group T1x only
2 months
Polynuclear eosinophils (g/l)
기간: 2 months
For group T1x only
2 months
Polynuclear basophils (g/l)
기간: 2 months
For group T1x only
2 months
D-dimers (ng/ml)
기간: 2 months
For group T1x only
2 months
Fibrin monomers (ng/ml)
기간: 2 months
For group T1x only
2 months
Trophoblast microparticles (%)
기간: 2 months
For group T1x only
2 months
Angiogenic marker CD146 (ng/ml)
기간: 2 months
For group T1x only
2 months
Total plasma concentration of free DNA (ng/ml)
기간: 2 months
For group T1x only
2 months
Total plasma concentration of nucleosomes (AU)
기간: 2 months
For group T1x only
2 months
Hemoglobin (g/l)
기간: -1 months
For group T2x only
-1 months
Hemoglobin (g/l)
기간: -2 months
For group T2x only
-2 months
Hemoglobin (g/l)
기간: -3 months
For group T2x only
-3 months
Hemoglobin (g/l)
기간: -4 months
For group T2x only
-4 months
Hemoglobin (g/l)
기간: -5 months
For group T2x only
-5 months
Hemoglobin (g/l)
기간: -6 months
For group T2x only
-6 months
Platelets (g/l)
기간: -1 months
For group T2x only
-1 months
Platelets (g/l)
기간: -2 months
For group T2x only
-2 months
Platelets (g/l)
기간: -3 months
For group T2x only
-3 months
Platelets (g/l)
기간: -4 months
For group T2x only
-4 months
Platelets (g/l)
기간: -5 months
For group T2x only
-5 months
Platelets (g/l)
기간: -6 months
For group T2x only
-6 months
Leukocytes (g/l)
기간: -1 months
For group T2x only
-1 months
Leukocytes (g/l)
기간: -2 months
For group T2x only
-2 months
Leukocytes (g/l)
기간: -3 months
For group T2x only
-3 months
Leukocytes (g/l)
기간: -4 months
For group T2x only
-4 months
Leukocytes (g/l)
기간: -5 months
For group T2x only
-5 months
Leukocytes (g/l)
기간: -6 months
For group T2x only
-6 months
Polynuclear neutrophils(g/l)
기간: -1 months
For group T2x only
-1 months
Polynuclear neutrophils(g/l)
기간: -2 months
For group T2x only
-2 months
Polynuclear neutrophils(g/l)
기간: -3 months
For group T2x only
-3 months
Polynuclear neutrophils(g/l)
기간: -4 months
For group T2x only
-4 months
Polynuclear neutrophils(g/l)
기간: -5 months
For group T2x only
-5 months
Polynuclear neutrophils(g/l)
기간: -6 months
For group T2x only
-6 months
Mean corpuscular volume (fL)
기간: -1 months
For group T2x only
-1 months
Mean corpuscular volume (fL)
기간: -2 months
For group T2x only
-2 months
Mean corpuscular volume (fL)
기간: -3 months
For group T2x only
-3 months
Mean corpuscular volume (fL)
기간: -4 months
For group T2x only
-4 months
Mean corpuscular volume (fL)
기간: -5 months
For group T2x only
-5 months
Mean corpuscular volume (fL)
기간: -6 months
For group T2x only
-6 months
Monocytes (g/l)
기간: -1 months
For group T2x only.
-1 months
Monocytes (g/l)
기간: -2 months
For group T2x only.
-2 months
Monocytes (g/l)
기간: -3 months
For group T2x only.
-3 months
Monocytes (g/l)
기간: -4 months
For group T2x only.
-4 months
Monocytes (g/l)
기간: -5 months
For group T2x only.
-5 months
Monocytes (g/l)
기간: -6 months
For group T2x only.
-6 months
Mean corpuscular hemoglobin (pg/GR)
기간: -1 months
For group T2x only.
-1 months
Mean corpuscular hemoglobin (pg/GR)
기간: -2 months
For group T2x only.
-2 months
Mean corpuscular hemoglobin (pg/GR)
기간: -3 months
For group T2x only.
-3 months
Mean corpuscular hemoglobin (pg/GR)
기간: -4 months
For group T2x only.
-4 months
Mean corpuscular hemoglobin (pg/GR)
기간: -5 months
For group T2x only.
-5 months
Mean corpuscular hemoglobin (pg/GR)
기간: -6 months
For group T2x only.
-6 months
Lymphocytes (g/l)
기간: -1 months
For group T2x only.
-1 months
Lymphocytes (g/l)
기간: -2 months
For group T2x only.
-2 months
Lymphocytes (g/l)
기간: -3 months
For group T2x only.
-3 months
Lymphocytes (g/l)
기간: -4 months
For group T2x only.
-4 months
Lymphocytes (g/l)
기간: -5 months
For group T2x only.
-5 months
Lymphocytes (g/l)
기간: -6 months
For group T2x only.
-6 months
Polynuclear eosinophils (g/l)
기간: -1 months
For group T2x only.
-1 months
Polynuclear eosinophils (g/l)
기간: -2 months
For group T2x only.
-2 months
Polynuclear eosinophils (g/l)
기간: -3 months
For group T2x only.
-3 months
Polynuclear eosinophils (g/l)
기간: -4 months
For group T2x only.
-4 months
Polynuclear eosinophils (g/l)
기간: -5 months
For group T2x only.
-5 months
Polynuclear eosinophils (g/l)
기간: -6 months
For group T2x only.
-6 months
Polynuclear basophils (g/l)
기간: -1 months
For group T2x only.
-1 months
Polynuclear basophils (g/l)
기간: -2 months
For group T2x only.
-2 months
Polynuclear basophils (g/l)
기간: -3 months
For group T2x only.
-3 months
Polynuclear basophils (g/l)
기간: -4 months
For group T2x only.
-4 months
Polynuclear basophils (g/l)
기간: -5 months
For group T2x only.
-5 months
Polynuclear basophils (g/l)
기간: -6 months
For group T2x only.
-6 months
D-dimers (ng/ml)
기간: -1 months
For group T2x only.
-1 months
D-dimers (ng/ml)
기간: -2 months
For group T2x only.
-2 months
D-dimers (ng/ml)
기간: -3 months
For group T2x only.
-3 months
D-dimers (ng/ml)
기간: -4 months
For group T2x only.
-4 months
D-dimers (ng/ml)
기간: -5 months
For group T2x only.
-5 months
D-dimers (ng/ml)
기간: -6 months
For group T2x only.
-6 months
Fibrin monomers (ng/ml)
기간: -1 months
For group T2x only.
-1 months
Fibrin monomers (ng/ml)
기간: -2 months
For group T2x only.
-2 months
Fibrin monomers (ng/ml)
기간: -3 months
For group T2x only.
-3 months
Fibrin monomers (ng/ml)
기간: -4 months
For group T2x only.
-4 months
Fibrin monomers (ng/ml)
기간: -5 months
For group T2x only.
-5 months
Fibrin monomers (ng/ml)
기간: -6 months
For group T2x only.
-6 months
Trophoblast microparticles (%)
기간: -1 months
For group T2x only.
-1 months
Trophoblast microparticles (%)
기간: -2 months
For group T2x only.
-2 months
Trophoblast microparticles (%)
기간: -3 months
For group T2x only.
-3 months
Trophoblast microparticles (%)
기간: -4 months
For group T2x only.
-4 months
Trophoblast microparticles (%)
기간: -5 months
For group T2x only.
-5 months
Trophoblast microparticles (%)
기간: -6 months
For group T2x only.
-6 months
Angiogenic marker CD146 (ng/ml)
기간: -1 months
For group T2x only.
-1 months
Angiogenic marker CD146 (ng/ml)
기간: -2 months
For group T2x only.
-2 months
Angiogenic marker CD146 (ng/ml)
기간: -3 months
For group T2x only.
-3 months
Angiogenic marker CD146 (ng/ml)
기간: -4 months
For group T2x only.
-4 months
Angiogenic marker CD146 (ng/ml)
기간: -5 months
For group T2x only.
-5 months
Angiogenic marker CD146 (ng/ml)
기간: -6 months
For group T2x only.
-6 months
Total plasma concentration of nucleosomes (AU)
기간: -1 months
For group T2x only.
-1 months
Total plasma concentration of nucleosomes (AU)
기간: -2 months
For group T2x only.
-2 months
Total plasma concentration of nucleosomes (AU)
기간: -3 months
For group T2x only.
-3 months
Total plasma concentration of nucleosomes (AU)
기간: -4 months
For group T2x only.
-4 months
Total plasma concentration of nucleosomes (AU)
기간: -5 months
For group T2x only.
-5 months
Total plasma concentration of nucleosomes (AU)
기간: -6 months
For group T2x only.
-6 months
Total plasma concentration of free DNA (ng/ml)
기간: -1 months
For group T2x only.
-1 months
Total plasma concentration of free DNA (ng/ml)
기간: -2 months
For group T2x only.
-2 months
Total plasma concentration of free DNA (ng/ml)
기간: -3 months
For group T2x only.
-3 months
Total plasma concentration of free DNA (ng/ml)
기간: -4 months
For group T2x only.
-4 months
Total plasma concentration of free DNA (ng/ml)
기간: -5 months
For group T2x only.
-5 months
Total plasma concentration of free DNA (ng/ml)
기간: -6 months
For group T2x only.
-6 months
Fibrinogen (g/l)
기간: 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.
Base line (day 0)
Fibrinogen (g/l)
기간: -1 months
For group T2x only.
-1 months
Fibrinogen (g/l)
기간: -2 months
For group T2x only.
-2 months
Fibrinogen (g/l)
기간: -3 months
For group T2x only.
-3 months
Fibrinogen (g/l)
기간: -4 months
For group T2x only.
-4 months
Fibrinogen (g/l)
기간: -5 months
For group T2x only.
-5 months
Fibrinogen (g/l)
기간: -6 months
For group T2x only.
-6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Sylvie Bouvier, MD, Centre Hospitalier Universitaire de Nîmes
  • 수석 연구원: Eve Mousty, MD, Centre Hospitalier Universitaire de Nîmes

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 6월 1일

기본 완료 (실제)

2018년 12월 17일

연구 완료 (실제)

2018년 12월 17일

연구 등록 날짜

최초 제출

2012년 11월 27일

QC 기준을 충족하는 최초 제출

2012년 11월 27일

처음 게시됨 (추정)

2012년 11월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 10일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

정맥 혈전증에 대한 임상 시험

Bloodwork, baseline에 대한 임상 시험

3
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