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AzTrials

Pregnancy RelatedGHISPENCT05142410

Understanding Post-translational Modifications to Circulating Histones Via Mass Spectrometry in Pregnant Women Developing Pre-eclampsia: A Retrospective Study

An observational study of Pregnancy Related and Pre-Eclampsia, 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
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Trial summary

This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47). Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies… 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 Related, Pre-Eclampsia
What is being tested?
Analysis of post-translational histone modifications via mass spectrometry
How many people
28 participants
Where
1 siteFrance
Study dates
1 Mar 2019to 1 Dec 2023
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 is based on frozen plasma samples from pregnant women, taken at the time of them giving birth from among the 50 women who constituted the GrossPath cohort. Fourteen of these women had had normal pregnancies and fourteen had developed pre-eclampsia. Cases are matched on maternal age, clinical event (delivery) and gestational age will be included from the GrossPath cohort.

Who may be able to join

  • Not applicable as this study is on samples from a biobank. The inclusion criteria for the "GrossPath" cohort were:
  • pregnant women followed at Nîmes University hospital for normal pregnancy or pregnancy with placental vascular pathology (pre-eclampsia and/or intra-uterine growth retardation).
  • The patient must have given her free and informed consent and signed the consent form.
  • The patient must be a member or beneficiary of a health insurance plan
  • Only women are included
  • Patients are at least 18 years old

Who cannot join

  • Not applicable as this is a study on samples from a biobank. The non-inclusion criteria of the "GrossPath" cohort were :
  • twin pregnancies.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nîmes University Hospital

    Nîmes, Gard, 30900

Other trials in France

About this study

Official title: A Retrospective Study Using Mass Spectrometry to Characterize Post-translational Modifications to Circulating Histones in Pregnant Women Developing Pre-eclampsia

This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47).

Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine.

Read more

Netosis is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Netosis occurs in pregnancy and is increased in vascular-placental complications. It can be studied by measuring circulating histones, particularly the citrullinated histone H3. Levels of this modified histone H3, as well as those of two other modifications, have recently been shown to increase during pregnancy. These levels have also been shown to be even greater in pregnancy complications.

The aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "GrossPath" cohort in order to propose new circulating biomarkers for placental vascular pathologies.

The post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.

Being tested
Analysis of post-translational histone modifications via mass spectrometry
Keywords
Pregnancy, Pre-eclampsia, Histones, Mass spectrometry, Neutrophils, Extracellular traps
Medical subject headings
Pre-Eclampsia

What participants receive

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

  • Analysis of post-translational histone modifications via mass spectrometryDiagnostic test

    During the "GrossHist" study (NCT04205383), only 3 post-translational histone modifications available in ELISA at the time were quantified thanks to a collaboration with the VOLITION™ company [Bouvier and Fortier et al. 2021]. The development of a new mass spectrometry approach based on nucleosome enrichment of plasma, developed by collaborators at VOLITION™, has made it possible to consider the description of all post-translational histone modifications (about 40 post-translational modifications involving histones H2A, H2B, H3 and H4).

Study groups in NCT05142410
Study groupRoleWhat they receive
Plasma from women with normal pregnanciesPlasma collected from women with normal pregnancies will be analyzed by mass spectrometry
Receives: Diagnostic Test: Analysis of post-translational histone modifications via mass spectrometry
Plasma from women with placenta-mediated complicationsPlasma collected from women who developed preeclampsia during pregnancy will be analyzed by mass spectrometry
Receives: Diagnostic Test: Analysis of post-translational histone modifications via mass spectrometry

What is being measured

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

  1. Presence of methylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of methylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  2. Presence of methylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of methylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  3. Presence of methylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of methylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  4. Presence of methylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of methylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  5. Presence of methylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of methylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  6. Presence of methylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of methylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  7. Presence of methylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of methylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  8. Presence of methylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of methylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  9. Presence of acetylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  10. Presence of acetylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  11. Presence of acetylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  12. Presence of acetylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  13. Presence of acetylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  14. Presence of acetylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  15. Presence of acetylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  16. Presence of acetylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of acetylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  17. Presence of phosphorylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  18. Presence of phosphorylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  19. Presence of phosphorylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  20. Presence of phosphorylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  21. Presence of phosphorylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  22. Presence of phosphorylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  23. Presence of phosphorylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  24. Presence of phosphorylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of phosphorylation in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  25. Presence of ubiquitination in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  26. Presence of ubiquitination in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  27. Presence of ubiquitination in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  28. Presence of ubiquitination in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  29. Presence of ubiquitination in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  30. Presence of ubiquitination in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  31. Presence of ubiquitination in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  32. Presence of ubiquitination in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of ubiquitination in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  33. Presence of citrullination in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  34. Presence of citrullination in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H2A and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  35. Presence of citrullination in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  36. Presence of citrullination in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H2B and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  37. Presence of citrullination in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  38. Presence of citrullination in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H3 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  39. Presence of citrullination in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

  40. Presence of citrullination in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry will be used to detect the presence or not of citrullination in histone H4 and recorded as YES/NO.

    Measured: At pregnancy term (max 41 weeks gestation)

Secondary outcomes (124)

  1. Intensity of methylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  2. Intensity of methylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  3. Intensity of methylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  4. Intensity of methylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  5. Intensity of methylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  6. Intensity of methylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  7. Intensity of methylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  8. Intensity of methylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  9. Intensity of acetylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  10. Intensity of acetylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  11. Intensity of acetylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  12. Intensity of acetylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  13. Intensity of acetylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  14. Intensity of acetylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  15. Intensity of acetylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  16. Intensity of acetylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  17. Intensity of phosphorylation in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  18. Intensity of phosphorylation in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  19. Intensity of phosphorylation in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  20. Intensity of phosphorylation in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  21. Intensity of phosphorylation in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  22. Intensity of phosphorylation in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  23. Intensity of phosphorylation in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  24. Intensity of phosphorylation in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  25. Intensity of ubiquitination in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  26. Intensity of ubiquitination in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  27. Intensity of ubiquitination in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  28. Intensity of ubiquitination in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  29. Intensity of ubiquitination in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  30. Intensity of ubiquitination in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  31. Intensity of ubiquitination in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  32. Intensity of ubiquitination in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  33. Intensity of citrullination in histone H2A in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  34. Intensity of citrullination in histone H2A in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  35. Intensity of citrullination in histone H2B in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  36. Intensity of citrullination in histone H2B in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  37. Intensity of citrullination in histone H3 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  38. Intensity of citrullination in histone H3 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  39. Intensity of citrullination in histone H4 in pregnant women with normal pregnancies

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  40. Intensity of citrullination in histone H4 in pregnant women developing pre-eclampsia

    Mass spectrometry, quantitative

    Measured: At pregnancy term (max 41 weeks gestation)

  41. Presence of methylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  42. Presence of methylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  43. Presence of methylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  44. Presence of methylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  45. Presence of methylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  46. Presence of methylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  47. Presence of methylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  48. Presence of methylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  49. Presence of acetylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  50. Presence of acetylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 of pregnancy

  51. Presence of acetylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  52. Presence of acetylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  53. Presence of acetylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  54. Presence of acetylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: After 34 weeks of pregnancy

  55. Presence of acetylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  56. Presence of acetylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  57. Presence of phosphorylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  58. Presence of phosphorylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  59. Presence of phosphorylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  60. Presence of phosphorylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  61. Presence of phosphorylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  62. Presence of phosphorylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  63. Presence of phosphorylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  64. Presence of phosphorylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  65. Presence of ubiquitination in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  66. Presence of ubiquitination in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  67. Presence of ubiquitination in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  68. Presence of ubiquitination in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  69. Presence of ubiquitination in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  70. Presence of ubiquitination in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  71. Presence of ubiquitination in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  72. Presence of ubiquitination in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  73. Presence of citrullination in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  74. Presence of citrullination in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  75. Presence of citrullination in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  76. Presence of citrullination in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  77. Presence of citrullination in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  78. Presence of citrullination in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  79. Presence of citrullination in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    YES/NO

    Measured: Before 34 weeks of pregnancy

  80. Presence of citrullination in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    YES/NO

    Measured: 34 to 41 weeks of pregnancy

  81. Intensity of methylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  82. Intensity of methylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  83. Intensity of methylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  84. Intensity of methylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  85. Intensity of methylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  86. Intensity of methylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  87. Intensity of methylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  88. Intensity of methylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  89. Intensity of acetylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  90. Intensity of acetylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  91. Intensity of acetylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  92. Intensity of acetylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  93. Intensity of acetylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  94. Intensity of acetylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  95. Intensity of acetylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  96. Intensity of acetylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  97. Intensity of phosphorylation in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  98. Intensity of phosphorylation in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  99. Intensity of phosphorylation in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  100. Intensity of phosphorylation in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  101. Intensity of phosphorylation in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  102. Intensity of phosphorylation in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  103. Intensity of phosphorylation in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  104. Intensity of phosphorylation in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  105. Intensity of ubiquitination in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  106. Intensity of ubiquitination in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  107. Intensity of ubiquitination in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  108. Intensity of ubiquitination in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 of pregnancy

  109. Intensity of ubiquitination in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  110. Intensity of ubiquitination in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  111. Intensity of ubiquitination in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  112. Intensity of ubiquitination in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  113. Intensity of citrullination in histone H2A in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  114. Intensity of citrullination in histone H2A in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  115. Intensity of citrullination in histone H2B in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  116. Intensity of citrullination in histone H2B in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  117. Intensity of citrullination in histone H3 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  118. Intensity of citrullination in histone H3 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  119. Intensity of citrullination in histone H4 in pregnant women developing pre-eclampsia before 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  120. Intensity of citrullination in histone H4 in pregnant women developing pre-eclampsia after 34 weeks of pregnancy

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

  121. Modifications in histones H2A, H2B, H3 and H4 in women developing pre-eclampsia early on compared with modifications in histones H2A, H2B, H3 and H4 in women with normal pregnancies.

    The presence of methylation, acetylation, phosphorylation, ubiquitination and citrullination in each histone in women developing pre-eclampsia early on will be recorded as YES/NO.

    Measured: Before 34 weeks of pregnancy

  122. Modifications in histones H2A, H2B, H3 and H4 in women developing pre-eclampsia later on compared with modifications in histones H2A, H2B, H3 and H4 in women with normal pregnancies.

    The presence of methylation, acetylation, phosphorylation, ubiquitination and citrullination in each histone in women developing pre-eclampsia later on will be recorded as YES/NO.

    Measured: 34 to 41 weeks of pregnancy

  123. Intensity of modifications in histones H2A, H2B, H3 and H4 in women developing pre-eclampsia early on compared with modifications in histones H2A, H2B, H3 and H4 in women with normal pregnancies.

    Mass spectrometry, quantitative

    Measured: Before 34 weeks of pregnancy

  124. Intensity of modifications in histones H2A, H2B, H3 and H4 in women developing pre-eclampsia later on compared with modifications in histones H2A, H2B, H3 and H4 in women with normal pregnancies.

    Mass spectrometry, quantitative

    Measured: 34 to 41 weeks of pregnancy

Timeline

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

  1. First posted2 Dec 2021
  2. Study start1 Mar 2019
  3. Primary completion30 Nov 2020
  4. Study completion1 Dec 2023

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
Case-control
Time perspective
Retrospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142410
Sponsor's protocol ID
NIMAO/2021-1/SB01
Acronym
GHISPE
Status last verified
Jan 2024
First submitted
18 Nov 2021
Last updated
31 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All data collection and management will be carried out by the BESPIM (Biostatistique, Epidémiologie clinique, Santé Publique \& Innovation en Méthodologie). The conditions of transfer of all or part of the research database are decided by the principal investigator and the research sponsor and are the subject of a written contract.

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Related and Pre-Eclampsia, 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 6 inclusion and 2 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 31 Jan 2024. 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?

Presence of methylation in histone H2A in pregnant women with normal pregnancies (time frame: At pregnancy term (max 41 weeks gestation)). The study lists 40 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 NCT05142410.

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 31 Jan 2024.

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