Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

Not Applicable

• Conditions: Oligohydramnios
• Interventions: Other: low sodium diet

• Registration Number: NCT03815968
• Lead Sponsor: Wolfson Medical Center

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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25
• Study Start: 2019-02
• Primary Completion: 2019-12
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low sodium diet	low sodium diet	women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.

Primary Outcome Measures

Name	Time	Method
amniotic fluid volume, assessed by ultrasound	two weeks	amniotic fluid volume after two weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University; 🇮🇱 H̱olon, Israel