Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Serum hepcidin at 11-14 weeks of gestation
研究概览
简要总结
Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. Firstly, investigator examines the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women will be tested.
详细描述
This is a mono-center, observational, controlled study with 2 parallel groups (obese versus non-obese pregnant women). The study will be conducted at the University Hospital of Basel, Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our outpatients' department in order to have a total of 169 evaluable women, considering a drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at 11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain, BMI and smoking status will be examined at all visits. Blood samples will be measured in the University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in January 2019.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a BMI ≥ 18.5 kg/m2,
- •maternal age ≥ 18 years,
- •singleton pregnancy,
- •gestational age at recruitment: 11-14 of gestational weeks,
- •written informed consent.
排除标准
- •pregnant women with a BMI< 18.5 kg/m2,
- •congenital anomaly of fetus,
- •severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
结局指标
主要结局
Serum hepcidin at 11-14 weeks of gestation
时间窗: 11-14 weeks of gestation
serum hepcidin (ng/ml)
次要结局
- Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;(at 24-28, 32-36 weeks of gestation)
- serum ferritin (µg/l),(at 24-28, 32-36 weeks of gestation)
- HRC (%),(at 11-14, 24-28, 32-36 weeks of gestation)
- hemoglobin (g/l),(at 11-14, 24-28, 32-36 weeks of gestation)
- red blood cells (x1012/l),(at 11-14, 24-28, 32-36 weeks of gestation)
- hematocrit (l/l),(at 11-14, 24-28, 32-36 weeks of gestation)
- MCV (fl),(at 11-14, 24-28, 32-36 weeks of gestation)
- MCH (pg),(at 11-14, 24-28, 32-36 weeks of gestation)
- MCHC (g/l),(at 11-14, 24-28, 32-36 weeks of gestation)
- red blood cell distribution width (%)(at 11-14, 24-28, 32-36 weeks of gestation)
- soluble transferrin receptors (mg/l)(at 24-28, 32-36 weeks of gestation)