The Influence of Low Sodium Diet on an Amniotic Fluid Index in a Patient That Diagnosed With Oligohydramnios and Assigned for Conservative Management - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- amniotic fluid volume, assessed by ultrasound
研究概览
简要总结
The investigators want to examine whether low salt diet can increase the amniotic fluid index in patients diagnosed with oligohydramnios and assigned for conservative management. A randomized controlled trial
详细描述
Few studies have addressed the changes in maternal diet as affecting the composition and amount of amniotic fluid.
Some articles have shown an increase in amniotic fluid volume as a result of maternal hydration during pregnancy through intravenous fluid infusions and oral fluid intake, the increase was evident in women with amniotic fluid and women with normal amniotic fluid volume. In a mechanism similar to that of liquid hydration, a low-salt diet may lead to an increase in the volume of amniotic fluid.
The investigators would like to examine whether a low-salt diet in women with amniotic fluid is able to significantly increase the amount of amniotic fluid compared with a regular diet.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 24-37 weeks of gestation, single fetus, who were diagnosed with an amniotic fluid index at the 5th percentile or below, according to the current gestational age
- •No medical indication for immediate delivery
排除标准
- •Refusal to participate in the study
- •A medical recommendation for delivery within two weeks of diagnosis
- •Fetal malformation or proof of fetal infection that known to cause oligohydramnios (eg CMV).
- •Premature rupture of membrane
- •Multiple pregnancy
- •Medical contraindication to the low-salt diet
研究组 & 干预措施
low sodium diet
women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.
干预措施: low sodium diet (Other)
regular diet
women diagnosed with oligohydramnios designated for conservative management applying a regular diet.
结局指标
主要结局
amniotic fluid volume, assessed by ultrasound
时间窗: two weeks
amniotic fluid volume after two weeks
次要结局
- induction of labor(up to 18 weeks (until delivery))
- labor type(up to 18 weeks (until delivery))
- gestational age at birth(up to 18 weeks (until delivery))
- Pregnancy and childbirth complications(up to 18 weeks (until delivery))
研究者
Michal Levy, MD
Principal Investigator
Wolfson Medical Center