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

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

Study Overview

• Status: Unknown
• Conditions: Oligohydramnios
• Intervention / Treatment: Other: low sodium diet

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Levy, MD; Phone Number: 0528591994; Email: levmichal@gmail.com
• Study Contact Backup: Name: Eran Weiner, MD; Email: eranweiner.md@gmail.com

Study Locations

• Israel
  • H̱olon, Israel, 6404519
    • Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Publications and helpful links

General Publications

• Rabie N, Magann E, Steelman S, Ounpraseuth S. Oligohydramnios in complicated and uncomplicated pregnancy: a systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):442-449. doi: 10.1002/uog.15929.
• Rainford M, Adair R, Scialli AR, Ghidini A, Spong CY. Amniotic fluid index in the uncomplicated term pregnancy. Prediction of outcome. J Reprod Med. 2001 Jun;46(6):589-92.
• Koski KG, Fergusson MA. Amniotic fluid composition responds to changes in maternal dietary carbohydrate and is related to metabolic status in term fetal rats. J Nutr. 1992 Feb;122(2):385-92. doi: 10.1093/jn/122.2.385.
• Gurekian CN, Koski KG. Amniotic fluid amino acid concentrations are modified by maternal dietary glucose, gestational age, and fetal growth in rats. J Nutr. 2005 Sep;135(9):2219-24. doi: 10.1093/jn/135.9.2219.
• Flack NJ, Sepulveda W, Bower S, Fisk NM. Acute maternal hydration in third-trimester oligohydramnios: effects on amniotic fluid volume, uteroplacental perfusion, and fetal blood flow and urine output. Am J Obstet Gynecol. 1995 Oct;173(4):1186-91. doi: 10.1016/0002-9378(95)91350-5.
• Doi S, Osada H, Seki K, Sekiya S. Effect of maternal hydration on oligohydramnios: a comparison of three volume expansion methods. Obstet Gynecol. 1998 Oct;92(4 Pt 1):525-9. doi: 10.1016/s0029-7844(98)00242-7.
• Umber A, Chohan MA. Intravenous maternal hydration in third trimester oligohydramnios: effect on amniotic fluid volume. J Coll Physicians Surg Pak. 2007 Jun;17(6):336-9.
• Rakova N, Muller DN, Staff AC, Luft FC, Dechend R. Novel ideas about salt, blood pressure, and pregnancy. J Reprod Immunol. 2014 Mar;101-102:135-139. doi: 10.1016/j.jri.2013.04.001. Epub 2013 May 30.
• Kirksey A, Pike RL, Callahan JA. Some effects of high and low sodium intakes during pregnancy in the rat. II. Electrolyte concentrations of maternal plasma, muscle, bone and brain and of placenta, amniotic fluid, fetal plasma and total fetus in normal pregnancy. J Nutr. 1962 May;77(1):43-51. doi: 10.1093/jn/77.1.43. No abstract available.
• Moore TR, Cayle JE. The amniotic fluid index in normal human pregnancy. Am J Obstet Gynecol. 1990 May;162(5):1168-73. doi: 10.1016/0002-9378(90)90009-v.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: oligohydroamnios; low salt diet
• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios
• Other Study ID Numbers: 0008-19-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No