Concentrations of Kynurenine During Pregnancy in Women With or Without Chronic Kidney Disease: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHU de Reims
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Kynurenine concentration at the 3rd trimester (32±1 weeks) in women with and without CKD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Multiple pregnancy
- •Kidney transplantation
- •Persons under guardianship or legal protection
研究组 & 干预措施
Women with chronic kidney disease
干预措施: Blood sampling (Other)
Women without chronic kidney disease
干预措施: Blood sampling (Other)
结局指标
主要结局
Kynurenine concentration at the 3rd trimester (32±1 weeks) in women with and without CKD
时间窗: 32±1 weeks
次要结局
- small-for-gestational-age(at 6 months)
- prematurity(at 6 months)
- fetal/neonatal mortality(at 6 months)
- Modeling of kynurenine needs across pregnancy in CKD women mean kynurenine concentration(at 6 months)
- gestational hypertension(at 6 months)
- HELLP syndrome(at 6 months)
- Kynurenine concentrations at 1st, 2nd, 3rd trimesters and 2 months postpartum in women with and without CKD(at 9 months)
- preeclampsia(at 6 months)
- postpartum hemorrhage(at 6 months)