NCT04497532Unknown不适用
The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Amniotic fluid index (AFI) after 2 weeks
研究概览
简要总结
To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
- •Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
- •Without a medical indication for an immediate delivery
排除标准
- •Medical recommendation for delivery within two weeks of diagnosis
- •Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
- •Premature rupture or membranes
- •Twins pregnancy
结局指标
主要结局
Amniotic fluid index (AFI) after 2 weeks
时间窗: Assess AFI two weeks after diet initiation
AFI as measured in ultrasound
次要结局
未报告次要终点
研究者
Liliya Tamayev
Principal Investigator
Wolfson Medical Center
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