An observational study in Pre-Eclampsia, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational
Formation of neutrophil extracellular traps (NETs) is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Two mechanisms of formation of NETs are described in the literature: vital mechanism via Toll Like Receptors (TLRs) and suicidal mechanism, dependent on the reactive oxygen species (ROS) pathway. The description of these two mechanisms of formation of NETs is recent and no data exist in the context of pregnancy.
This is a descriptive pilot study on a ready-constituted biobank. It is an ancillary study to a previous cohort (RCB number: 2014-A01120-47, NCT01736826).
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.
Formation of NETs is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Formation of NETs 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.
Furthermore, two mechanisms of formation of NETs are described in the literature: vital mechanism via Toll Like Receptors (TLRs) and suicidal mechanism, dependent on the reactive oxygen species (ROS) pathway. The description of these two mechanisms of formation of NETs is recent and no data exist in the context of pregnancy.
The aim of this study is to describe the part of these two mechanisms in normal and complicated pre-eclampsia pregnancies in order to obtain a better physiopathological knowledge of pre-eclampsia to propose new circulating biomarkers and to develop new therapeutic strategies for placental vascular pathologies.
883 studies on the registry are indexed under Pre-Eclampsia; 238 are open to participants now.
This study's enrollment of 26 is below the median of 160 across 381 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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The study is based on frozen plasma samples from pregnant women, taken at the time of them giving birth from among the 85 women who constituted the previous cohort (NCT01736826). Thirteen of these women had had normal pregnancies and thirteen had developed pre-eclampsia. Cases are matched on maternal age, clinical event (delivery) and gestational age will be included from the previous cohort (NCT01736826).
Not applicable as this study is on samples from a biobank.
Inclusion criteria:
The inclusion criteria for the previous cohort (NCT01736826) were:
Exclusion Criteria:
Not applicable as this is a study on samples from a biobank. The non-inclusion criteria of the previous cohort (NCT01736826) were :
Plasma collected from women who developed preeclampsia during pregnancy will be analyzed for mechanism of NETs formation.
Plasma collected from women with normal pregnancies will be analyzed for mechanism of NETs formation.
To evaluate vital mechanism of NETs formation between pregnant women with normal pregnancies and those developing preeclampsia.
Evaluation of vital mechanism of NETs formation between pregnant women with normal pregnancies and those developing preeclampsia.
Time frame: 3 months
To compare the proportion of vital mechanism of NETs formation in the presence or absence of a TLR-blocking antibody within each group: normal pregnancy and preeclamptic pregnancy.
Evaluation of the proportion of vital mechanism of NETs formation in the presence or absence of a TLR-blocking antibody within each group: normal pregnancy and preeclamptic pregnancy.
Time frame: 3 months
To compare the proportion of vital mechanism of NETs formation in the presence of a TLR-blocking antibody between pregnant women with normal pregnancies and those developing preeclampsia.
Evaluation of the proportion of vital mechanism of NETs formation in the presence of a TLR-blocking antibody between pregnant women with normal pregnancies and those developing preeclampsia.
Time frame: 3 months
To compare vital and suicidal mechanisms of NETs formation between pregnant women with a normal pregnancy and those developing preeclampsia.
Evaluation of vital and suicidal mechanisms of NETs formation between pregnant women with a normal pregnancy and those developing preeclampsia.
Time frame: 3 months
To compare vital and suicidal mechanisms of NETs formation in the presence or absence of a TLR blocking antibody or ROS inhibitor (DPI) separately within each group: normal pregnancy and preeclamptic pregnancy.
Evaluation of vital and suicidal mechanisms of NETs formation in the presence or absence of a TLR blocking antibody or ROS inhibitor (DPI) separately within each group: normal pregnancy and preeclamptic pregnancy.
Time frame: 3 months
To compare vital and suicidal mechanisms of NETs formation in the presence of TLR blocking antibody or ROS inhibitor (DPI) between pregnant women with normal pregnancy and those developing preeclampsia.
Evaluation of vital and suicidal mechanisms of NETs formation in the presence of TLR blocking antibody or ROS inhibitor (DPI) between pregnant women with normal pregnancy and those developing preeclampsia.
Time frame: 3 months
To compare the proportion of suicidal mechanism of NETs formation between pregnant women with a normal pregnancy and those developing preeclampsia.
Evaluation of the proportion of suicidal mechanism of NETs formation between pregnant women with a normal pregnancy and those developing preeclampsia.
Time frame: 3 months
To compare suicidal mechanism of NETs formation in the presence or absence of ROS inhibitor (PGD) separately within each group: normal pregnancy and preeclamptic pregnancy.
Evaluation of suicidal mechanism of NETs formation in the presence or absence of ROS inhibitor (PGD) separately within each group: normal pregnancy and preeclamptic pregnancy.
Time frame: 3 months
To compare the proportion of suicidal mechanism of NETs formation in the presence of an ROS inhibitor (PGD) between pregnant women with a normal pregnancy and those developing preeclampsia.
Evaluation of the proportion of suicidal mechanism of NETs formation in the presence of an ROS inhibitor (PGD) between pregnant women with a normal pregnancy and those developing preeclampsia
Time frame: 3 months
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes