AzTrials
AzTrials

PregnancyNCT01736826

Free DNA and Nucleosome Concentrations in Pathological Pregnancies

An observational study of Pregnancy and Venous Thrombosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Venous Thrombosis, Pulmonary Embolism
What is being tested?
Bloodwork, baseline, Blood work, Months 1 & 2 and Bloodwork, Months -1 to -6
How many people
137 participants
Where
1 siteFrance
Study dates
Jun 2015to 11 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • The patient must have given her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • 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)
  • The patient is available for 3 months of follow-up
  • The patient is a non-pregnant healthy volunteer
  • No identifiable chronic pathologies
Show all 15Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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)
  • 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)
  • 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)
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: 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).
Read the 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.
Being tested
Bloodwork, baseline, Blood work, Months 1 & 2, Bloodwork, Months -1 to -6
Keywords
plasma nucleosome concentration, plasma free DNA concentration
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Hypertension, Pregnancy-Induced, Eclampsia, HELLP Syndrome, Pre-Eclampsia, Fetal Death, Placental Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bloodwork, baselineBiological

    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.

  • Blood work, Months 1 & 2Biological

    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.

  • Bloodwork, Months -1 to -6Biological

    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.

Study groups in NCT01736826
Study groupRoleWhat they receive
Group P: pregnancy w/complicationsThe 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
Receives: Biological: Bloodwork, baseline
Group T1: Healthy volunteersHealthy volunteers with no history of chronic or neoplastic disease. 30 healthy volunteers will be included. Interventions to be administered: Bloodwork, baseline
Receives: Biological: Bloodwork, baseline
Group T2: Pregnancy, no complicationsPregnant 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
Receives: Biological: Bloodwork, baseline
Group T1x: 15 Healthy volunteers15 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
Receives: Biological: Bloodwork, baseline; Biological: Blood work, Months 1 & 2
Group T2x: 15 Pregnancy, no complications15 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
Receives: Biological: Bloodwork, baseline; Biological: Bloodwork, Months -1 to -6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total plasma concentration of free DNA (ng/ml)

    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.

    Measured: Base line (day 0)

  2. Total plasma concentration of nucleosomes (AU)

    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

    Measured: Base line (day 0)

Secondary outcomes (149)

  1. Hemoglobin (g/l)

    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.

    Measured: baseline (day 0)

  2. Platelets (g/l)

    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.

    Measured: baseline (day 0)

  3. Leukocytes (g/l)

    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.

    Measured: baseline (day 0)

  4. Polynuclear neutrophils(g/l)

    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.

    Measured: baseline (day 0)

  5. Mean corpuscular volume (fL)

    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.

    Measured: baseline (day 0)

  6. Monocytes (g/l)

    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.

    Measured: baseline (day 0)

  7. Mean corpuscular hemoglobin (pg/GR)

    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.

    Measured: baseline (day 0)

  8. Lymphocytes (g/l)

    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.

    Measured: baseline (day 0)

  9. Polynuclear eosinophils (g/l)

    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.

    Measured: baseline (day 0)

  10. Polynuclear basophils (g/l)

    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.

    Measured: baseline (day 0)

  11. D-dimers (ng/ml)

    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.

    Measured: baseline (day 0)

  12. Fibrin monomers (ng/ml)

    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.

    Measured: baseline (day 0)

  13. Trophoblast microparticles (%)

    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.

    Measured: baseline (day 0)

  14. Angiogenic marker CD146 (ng/ml)

    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.

    Measured: baseline (day 0)

  15. Hemoglobin (g/l)

    For group T1x only

    Measured: 1 month

  16. Platelets (g/l)

    For group T1x only

    Measured: 1 month

  17. Leukocytes (g/l)

    For group T1x only

    Measured: 1 month

  18. Polynuclear neutrophils(g/l)

    For group T1x only

    Measured: 1 month

  19. Mean corpuscular volume (fL)

    For group T1x only

    Measured: 1 month

  20. Monocytes (g/l)

    For group T1x only

    Measured: 1 month

  21. Mean corpuscular hemoglobin (pg/GR)

    For group T1x only

    Measured: 1 month

  22. Lymphocytes (g/l)

    For group T1x only

    Measured: 1 month

  23. Polynuclear eosinophils (g/l)

    For group T1x only

    Measured: 1 month

  24. Polynuclear basophils (g/l)

    For group T1x only

    Measured: 1 month

  25. D-dimers (ng/ml)

    For group T1x only

    Measured: 1 month

  26. Fibrin monomers (ng/ml)

    For group T1x only

    Measured: 1 month

  27. Trophoblast microparticles (%)

    For group T1x only

    Measured: 1 month

  28. Angiogenic marker CD146 (ng/ml)

    For group T1x only

    Measured: 1 month

  29. Total plasma concentration of free DNA (ng/ml)

    For group T1x only

    Measured: 1 month

  30. Total plasma concentration of nucleosomes (AU)

    For group T1x only

    Measured: 1 month

  31. Hemoglobin (g/l)

    For group T1x only

    Measured: 2 months

  32. Platelets (g/l)

    For group T1x only

    Measured: 2 months

  33. Leukocytes (g/l)

    For group T1x only

    Measured: 2 months

  34. Polynuclear neutrophils(g/l)

    For group T1x only

    Measured: 2 months

  35. Mean corpuscular volume (fL)

    For group T1x only

    Measured: 2 months

  36. Monocytes (g/l)

    For group T1x only

    Measured: 2 months

  37. Mean corpuscular hemoglobin (pg/GR)

    For group T1x only

    Measured: 2 months

  38. Lymphocytes (g/l)

    For group T1x only

    Measured: 2 months

  39. Polynuclear eosinophils (g/l)

    For group T1x only

    Measured: 2 months

  40. Polynuclear basophils (g/l)

    For group T1x only

    Measured: 2 months

  41. D-dimers (ng/ml)

    For group T1x only

    Measured: 2 months

  42. Fibrin monomers (ng/ml)

    For group T1x only

    Measured: 2 months

  43. Trophoblast microparticles (%)

    For group T1x only

    Measured: 2 months

  44. Angiogenic marker CD146 (ng/ml)

    For group T1x only

    Measured: 2 months

  45. Total plasma concentration of free DNA (ng/ml)

    For group T1x only

    Measured: 2 months

  46. Total plasma concentration of nucleosomes (AU)

    For group T1x only

    Measured: 2 months

  47. Hemoglobin (g/l)

    For group T2x only

    Measured: -1 months

  48. Hemoglobin (g/l)

    For group T2x only

    Measured: -2 months

  49. Hemoglobin (g/l)

    For group T2x only

    Measured: -3 months

  50. Hemoglobin (g/l)

    For group T2x only

    Measured: -4 months

  51. Hemoglobin (g/l)

    For group T2x only

    Measured: -5 months

  52. Hemoglobin (g/l)

    For group T2x only

    Measured: -6 months

  53. Platelets (g/l)

    For group T2x only

    Measured: -1 months

  54. Platelets (g/l)

    For group T2x only

    Measured: -2 months

  55. Platelets (g/l)

    For group T2x only

    Measured: -3 months

  56. Platelets (g/l)

    For group T2x only

    Measured: -4 months

  57. Platelets (g/l)

    For group T2x only

    Measured: -5 months

  58. Platelets (g/l)

    For group T2x only

    Measured: -6 months

  59. Leukocytes (g/l)

    For group T2x only

    Measured: -1 months

  60. Leukocytes (g/l)

    For group T2x only

    Measured: -2 months

  61. Leukocytes (g/l)

    For group T2x only

    Measured: -3 months

  62. Leukocytes (g/l)

    For group T2x only

    Measured: -4 months

  63. Leukocytes (g/l)

    For group T2x only

    Measured: -5 months

  64. Leukocytes (g/l)

    For group T2x only

    Measured: -6 months

  65. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -1 months

  66. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -2 months

  67. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -3 months

  68. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -4 months

  69. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -5 months

  70. Polynuclear neutrophils(g/l)

    For group T2x only

    Measured: -6 months

  71. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -1 months

  72. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -2 months

  73. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -3 months

  74. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -4 months

  75. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -5 months

  76. Mean corpuscular volume (fL)

    For group T2x only

    Measured: -6 months

  77. Monocytes (g/l)

    For group T2x only.

    Measured: -1 months

  78. Monocytes (g/l)

    For group T2x only.

    Measured: -2 months

  79. Monocytes (g/l)

    For group T2x only.

    Measured: -3 months

  80. Monocytes (g/l)

    For group T2x only.

    Measured: -4 months

  81. Monocytes (g/l)

    For group T2x only.

    Measured: -5 months

  82. Monocytes (g/l)

    For group T2x only.

    Measured: -6 months

  83. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -1 months

  84. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -2 months

  85. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -3 months

  86. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -4 months

  87. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -5 months

  88. Mean corpuscular hemoglobin (pg/GR)

    For group T2x only.

    Measured: -6 months

  89. Lymphocytes (g/l)

    For group T2x only.

    Measured: -1 months

  90. Lymphocytes (g/l)

    For group T2x only.

    Measured: -2 months

  91. Lymphocytes (g/l)

    For group T2x only.

    Measured: -3 months

  92. Lymphocytes (g/l)

    For group T2x only.

    Measured: -4 months

  93. Lymphocytes (g/l)

    For group T2x only.

    Measured: -5 months

  94. Lymphocytes (g/l)

    For group T2x only.

    Measured: -6 months

  95. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -1 months

  96. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -2 months

  97. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -3 months

  98. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -4 months

  99. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -5 months

  100. Polynuclear eosinophils (g/l)

    For group T2x only.

    Measured: -6 months

  101. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -1 months

  102. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -2 months

  103. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -3 months

  104. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -4 months

  105. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -5 months

  106. Polynuclear basophils (g/l)

    For group T2x only.

    Measured: -6 months

  107. D-dimers (ng/ml)

    For group T2x only.

    Measured: -1 months

  108. D-dimers (ng/ml)

    For group T2x only.

    Measured: -2 months

  109. D-dimers (ng/ml)

    For group T2x only.

    Measured: -3 months

  110. D-dimers (ng/ml)

    For group T2x only.

    Measured: -4 months

  111. D-dimers (ng/ml)

    For group T2x only.

    Measured: -5 months

  112. D-dimers (ng/ml)

    For group T2x only.

    Measured: -6 months

  113. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -1 months

  114. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -2 months

  115. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -3 months

  116. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -4 months

  117. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -5 months

  118. Fibrin monomers (ng/ml)

    For group T2x only.

    Measured: -6 months

  119. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -1 months

  120. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -2 months

  121. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -3 months

  122. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -4 months

  123. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -5 months

  124. Trophoblast microparticles (%)

    For group T2x only.

    Measured: -6 months

  125. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -1 months

  126. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -2 months

  127. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -3 months

  128. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -4 months

  129. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -5 months

  130. Angiogenic marker CD146 (ng/ml)

    For group T2x only.

    Measured: -6 months

  131. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -1 months

  132. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -2 months

  133. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -3 months

  134. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -4 months

  135. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -5 months

  136. Total plasma concentration of nucleosomes (AU)

    For group T2x only.

    Measured: -6 months

  137. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -1 months

  138. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -2 months

  139. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -3 months

  140. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -4 months

  141. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -5 months

  142. Total plasma concentration of free DNA (ng/ml)

    For group T2x only.

    Measured: -6 months

  143. Fibrinogen (g/l)

    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.

    Measured: Base line (day 0)

  144. Fibrinogen (g/l)

    For group T2x only.

    Measured: -1 months

  145. Fibrinogen (g/l)

    For group T2x only.

    Measured: -2 months

  146. Fibrinogen (g/l)

    For group T2x only.

    Measured: -3 months

  147. Fibrinogen (g/l)

    For group T2x only.

    Measured: -4 months

  148. Fibrinogen (g/l)

    For group T2x only.

    Measured: -5 months

  149. Fibrinogen (g/l)

    For group T2x only.

    Measured: -6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study startJun 2015
  3. Primary completion11 Dec 2017
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736826
Sponsor's protocol ID
LOCAL/2012/SB-01
Other IDs
2014-A01120-47
Status last verified
Jan 2019
First submitted
27 Nov 2012
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Bouvier S, Mousty E, Fortier M, Demattei C, Mercier E, Nouvellon E, Chea M, Grosjean F, Letouzey V, Gris JC. Placenta-mediated complications: Nucleosomes and free DNA concentrations differ depending on subtypes. J Thromb Haemost. 2020 Dec;18(12):3371-3380. doi: 10.1111/jth.15105. Epub 2020 Oct 18.

    PubMed 32979032

  • Bouvier S, Traboulsi W, Blois SM, Demattei C, Joshkon A, Mousty E, Nollet M, Paulmyer-Lacroix O, Foucault-Bertaud A, Fortier M, Leroyer AS, Bachelier R, Letouzey V, Alfaidy N, Dignat-George F, Blot-Chabaud M, Gris JC, Bardin N. Soluble CD146 is increased in preeclampsia and interacts with galectin-1 to regulate trophoblast migration through VEGFR2 receptor. F S Sci. 2022 Feb;3(1):84-94. doi: 10.1016/j.xfss.2021.11.002. Epub 2021 Nov 19.

    PubMed 35559998

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Venous Thrombosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total plasma concentration of free DNA (ng/ml) (time frame: Base line (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736826, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in