An interventional study of Blood and placenta samples in Pathology of Pregnancy, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 2 sites in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.
Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.
Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.
Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.
In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.
In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's enrollment of 95 is below the median of 157 across 22 interventional studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The placenta sample is realised, specially for the study, in surgical unit after the delivery. The blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission.
Evaluate the percentage of Treg in maternal blood at the time of admission
Time frame: the day of delivery or 7 days after the admission if no delivery
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon →