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Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03815968
Enrollment
80
Registered
2019-01-25
Start date
2019-02-28
Completion date
2020-02-29
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligohydramnios

Keywords

oligohydroamnios, low salt diet

Brief summary

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

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.

Interventions

included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
amniotic fluid volume, assessed by ultrasoundtwo weeksamniotic fluid volume after two weeks

Secondary

MeasureTime frameDescription
gestational age at birthup to 18 weeks (until delivery)
induction of laborup to 18 weeks (until delivery)The percentage of pregnant women who underwent birth induction
labor typeup to 18 weeks (until delivery)Cesarean section, vaginal birth or vaginal birth
Pregnancy and childbirth complicationsup to 18 weeks (until delivery)obstetrics complications and neonatal complications

Countries

Israel

Contacts

Primary ContactMichal Levy, MD
levmichal@gmail.com0528591994
Backup ContactEran Weiner, MD
eranweiner.md@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026