Low Sodium Diet in Oligohydramnios Assigned for Conservative Management
Primary Purpose
Oligohydramnios
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
low sodium diet
Sponsored by
About this trial
This is an interventional treatment trial for Oligohydramnios focused on measuring oligohydroamnios, low salt 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
Sites / Locations
- Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
low sodium diet
regular diet
Arm Description
women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.
women diagnosed with oligohydramnios designated for conservative management applying a regular diet.
Outcomes
Primary Outcome Measures
amniotic fluid volume, assessed by ultrasound
amniotic fluid volume after two weeks
Secondary Outcome Measures
gestational age at birth
induction of labor
The percentage of pregnant women who underwent birth induction
labor type
Cesarean section, vaginal birth or vaginal birth
Pregnancy and childbirth complications
obstetrics complications and neonatal complications
Full Information
NCT ID
NCT03815968
First Posted
January 19, 2019
Last Updated
January 23, 2019
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03815968
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligohydramnios
Keywords
oligohydroamnios, low salt diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low sodium diet
Arm Type
Experimental
Arm Description
women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.
Arm Title
regular diet
Arm Type
No Intervention
Arm Description
women diagnosed with oligohydramnios designated for conservative management applying a regular diet.
Intervention Type
Other
Intervention Name(s)
low sodium diet
Other Intervention Name(s)
low salt diet
Intervention Description
included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.
Primary Outcome Measure Information:
Title
amniotic fluid volume, assessed by ultrasound
Description
amniotic fluid volume after two weeks
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
gestational age at birth
Time Frame
up to 18 weeks (until delivery)
Title
induction of labor
Description
The percentage of pregnant women who underwent birth induction
Time Frame
up to 18 weeks (until delivery)
Title
labor type
Description
Cesarean section, vaginal birth or vaginal birth
Time Frame
up to 18 weeks (until delivery)
Title
Pregnancy and childbirth complications
Description
obstetrics complications and neonatal complications
Time Frame
up to 18 weeks (until delivery)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Levy, MD
Phone
0528591994
Email
levmichal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Weiner, MD
Email
eranweiner.md@gmail.com
Facility Information:
Facility Name
Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University
City
H̱olon
ZIP/Postal Code
6404519
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27062200
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.
Results Reference
result
PubMed Identifier
11441685
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.
Results Reference
result
PubMed Identifier
1732479
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.
Results Reference
result
PubMed Identifier
16140901
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.
Results Reference
result
PubMed Identifier
7485317
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.
Results Reference
result
PubMed Identifier
9764623
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.
Results Reference
result
PubMed Identifier
17623581
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.
Results Reference
result
PubMed Identifier
23726817
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.
Results Reference
result
PubMed Identifier
14456322
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.
Results Reference
result
PubMed Identifier
2187347
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.
Results Reference
result
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Low Sodium Diet in Oligohydramnios Assigned for Conservative Management
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