Набор скоро начнётся NCT07411937

Kynurenine Concentrations During Pregnancy in Women With or Without Chronic Kidney Disease - A Prospective Multicenter Study

Без фазы С лечением Chronic Kidney Diseases Pregnancy Preeclampsia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood sampling.
Кому может быть актуально: Состояния в реестре: Chronic Kidney Diseases, Pregnancy, Preeclampsia. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Concentrations of Kynurenine During Pregnancy in Women With or Without Chronic Kidney Disease: A Prospective Multicenter Study

Обзор

Chronic kidney disease (CKD) affects more than 10% of the population worldwide and represents the second most important risk factor for preeclampsia, a life-threatening complication of pregnancy responsible for approximately 80,000 maternal and 500,000 perinatal deaths each year. Experimental studies have suggested a causal link between CKD, relative kynurenine deficiency during pregnancy, and preeclampsia development. Kynurenine, a tryptophan metabolite, plays a central role at the materno-fetal interface, supporting placental energy production, maternal-fetal immune tolerance, and placental perfusion. This study will prospectively assess and compare longitudinal kynurenine concentrations in pregnant women with and without CKD, and evaluate their associations with maternal and fetal outcomes.

Подробное описание

This is a multicenter, prospective cohort study including 204 pregnant women, with or without chronic kidney disease (CKD stages 2 to 4). Participants will be enrolled before 14 weeks of gestation. Blood samples (14 mL) will be collected at the 1st, 2nd, and 3rd trimesters and 2 months postpartum for kynurenine measurement, centrally analyzed at CHU Reims using LC-MS/MS. Additional data include maternal demographics, medical and obstetric history, anthropometry, laboratory data (creatinine, hemoglobin, hematocrit, proteinuria), blood pressure, ultrasound (growth parameters, umbilical artery Doppler), and maternal-fetal outcomes (preeclampsia, gestational hypertension, HELLP, hemorrhage, SGA, prematurity, mortality). The primary objective is to compare kynurenine concentrations in the 3rd trimester between women with and without CKD. Secondary objectives include describing longitudinal kynurenine evolution, its association with maternal-fetal outcomes, and modeling kynurenine needs during pregnancy in CKD.

Вмешательства

Другое Blood sampling
A 14ml blood sample will be collected during the first second and third trimesters of pregnancy and at 2 months (+ 1 month post partum)

Первичные конечные точки

Kynurenine concentration at the 3rd trimester (32±1 weeks) in women with and without CKD [Срок оценки: 32±1 weeks]

Вторичные конечные точки (9)

Kynurenine concentrations at 1st, 2nd, 3rd trimesters and 2 months postpartum in women with and without CKD [Срок оценки: at 9 months]
preeclampsia [Срок оценки: at 6 months]
gestational hypertension [Срок оценки: at 6 months]
HELLP syndrome [Срок оценки: at 6 months]
postpartum hemorrhage [Срок оценки: at 6 months]
small-for-gestational-age [Срок оценки: at 6 months]
prematurity [Срок оценки: at 6 months]
fetal/neonatal mortality [Срок оценки: at 6 months]
Modeling of kynurenine needs across pregnancy in CKD women mean kynurenine concentration [Срок оценки: at 6 months]

Критерии участия

Критерии включения

Adult pregnant women <14 weeks of amenorrhea
With or without CKD stage 2-4 (eGFR 15-89 mL/min/1.73m², diagnosed before pregnancy)
Written informed consent
Affiliation to a social security system