Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Oligohydramnios

Intervention / Treatment
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* Other: low sodium diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low sodium diet<br>women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet. | Other: low sodium diet<br>* included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.<br>* Other names: low salt diet;|
| No Intervention: regular diet<br>women diagnosed with oligohydramnios designated for conservative management applying a regular diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amniotic fluid volume, assessed by ultrasound | amniotic fluid volume after two weeks | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational age at birth |  | up to 18 weeks (until delivery) | 
| induction of labor | The percentage of pregnant women who underwent birth induction | up to 18 weeks (until delivery) | 
| labor type | Cesarean section, vaginal birth or vaginal birth | up to 18 weeks (until delivery) | 
| Pregnancy and childbirth complications | obstetrics complications and neonatal complications | up to 18 weeks (until delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligohydroamnios, low salt diet