Vital Mechanism of NETs Formation vs. Suicidal Mechanism of NETs Formation During Normal Pregnancy and Preeclampsia

NCT05470712 | Completed

• 1 other identifier: NIMAO/2022-1/SB-01
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia

Keywords

Pregnancy; Pre-eclampsia; Neutrophils; Extracellular traps

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

• 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.

  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.

  3 months

• To compare vital and suicidal mechanisms of NETs formation between pregnant women with a normal pregnancy and those developing preeclampsia.

  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.

  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.

  3 months

Study Arms (2)

Plasma from women with preeclampsia

Plasma collected from women who developed preeclampsia during pregnancy will be analyzed for mechanism of NETs formation.

Plasma from women with normal pregnancies

Plasma collected from women with normal pregnancies will be analyzed for mechanism of NETs formation.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• pregnant women followed at Nimes 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

You may not qualify if:

• twin pregnancies.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Guillotin F, Fortier M, Portes M, Demattei C, Mousty E, Nouvellon E, Mercier E, Chea M, Letouzey V, Gris JC, Bouvier S. Vital NETosis vs. suicidal NETosis during normal pregnancy and preeclampsia. Front Cell Dev Biol. 2023 Jan 5;10:1099038. doi: 10.3389/fcell.2022.1099038. eCollection 2022.

  PMID: 36684420 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study is based on the NETs formation mechanism of frozen plasma samples from patients included in a previous cohort (RCB 2014-A01120-47, NCT01736826). The benefits will ultimately be a better understanding of the physiopathological mechanisms involved in the occurrence of this placental vascular pathology

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anissa MEGZARI

  CHU Nimes

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: July 20, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 4, 2025

Record last verified: 2023-02

Locations

FR (1)