Clinical trial NCT03815968: Low Sodium Diet in Oligohydramnios Assigned for Conservative Management
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oligohydramnios
Keywords: oligohydroamnios
low salt diet
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-01-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: amniotic fluid volume, assessed by ultrasound
timeFrame: two weeks
Secondary outcomes:
measure: gestational age at birth
timeFrame: up to 18 weeks (until delivery)
measure: induction of labor
timeFrame: up to 18 weeks (until delivery)
measure: labor type
timeFrame: up to 18 weeks (until delivery)
measure: Pregnancy and childbirth complications
timeFrame: up to 18 weeks (until delivery)
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University
Study officials:
References:
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.
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.
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. doi: 10.1093/jn/122.2.385.
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. doi: 10.1093/jn/135.9.2219.
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. doi: 10.1016/0002-9378(95)91350-5.
citation: 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.
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.
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.
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 pregnancy. J Nutr. 1962 May;77(1):43-51. doi: 10.1093/jn/77.1.43. No abstract available.
citation: 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.