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Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

W

Wolfson Medical Center (WMC)

Status

Unknown

Conditions

Oligohydramnios

Treatments

Other: low sodium diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03815968
0008-19-WOMC

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

low sodium diet
Experimental group
Description:
women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.
Treatment:
Other: low sodium diet
regular diet
No Intervention group
Description:
women diagnosed with oligohydramnios designated for conservative management applying a regular diet.

Trial contacts and locations

1

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Central trial contact

Eran Weiner, MD; Michal Levy, MD

Data sourced from clinicaltrials.gov

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