Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

Oligohydramnios Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03815968
• Other study ID #: 0008-19-WOMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: February 2020

Study information

• Verified date: January 2019
• Source: Wolfson Medical Center
• Contact: Michal Levy, MD
• Phone: 0528591994
• Email: levmichal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Oligohydramnios

Intervention

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

Locations

Country	Name	City	State
Israel	Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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 pre — View Citation

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. — View Citation

Moore TR, Cayle JE. The amniotic fluid index in normal human pregnancy. Am J Obstet Gynecol. 1990 May;162(5):1168-73. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amniotic fluid volume, assessed by ultrasound	amniotic fluid volume after two weeks	two weeks
Secondary	gestational age at birth		up to 18 weeks (until delivery)
Secondary	induction of labor	The percentage of pregnant women who underwent birth induction	up to 18 weeks (until delivery)
Secondary	labor type	Cesarean section, vaginal birth or vaginal birth	up to 18 weeks (until delivery)
Secondary	Pregnancy and childbirth complications	obstetrics complications and neonatal complications	up to 18 weeks (until delivery)