ClinicalTrials.gg
Status unknownNCT03815968Updated Jan 25, 2019

Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

An interventional study of low sodium diet in Oligohydramnios, sponsored by Wolfson Medical Center. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Oligohydramnios

Browse trials for

Keywords

  • oligohydroamnios
  • low salt diet
03

In context

Oligohydramnios

25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.

This study's planned enrollment of 80 is below the median of 91 across 16 interventional studies indexed under Oligohydramnios.

Browse Oligohydramnios studies →

Lead sponsor

Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to the low-salt diet
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    low sodium diet

    women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.

    Other: low sodium diet

  • No intervention
    regular diet

    women diagnosed with oligohydramnios designated for conservative management applying a regular diet.

Interventions

  • Otherlow sodium diet

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

    Also known as: low salt diet

06

What researchers measure

Primary outcomes

  1. amniotic fluid volume, assessed by ultrasound

    amniotic fluid volume after two weeks

    Time frame: two weeks

Secondary outcomes

  1. gestational age at birth

    Time frame: up to 18 weeks (until delivery)

  2. induction of labor

    The percentage of pregnant women who underwent birth induction

    Time frame: up to 18 weeks (until delivery)

  3. labor type

    Cesarean section, vaginal birth or vaginal birth

    Time frame: up to 18 weeks (until delivery)

  4. Pregnancy and childbirth complications

    obstetrics complications and neonatal complications

    Time frame: up to 18 weeks (until delivery)

07

Study locations

1 site
  • Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University
    H̱olon, 6404519, Israel
08

References and documents

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. PubMed 27062200 ↗
  • 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. PubMed 11441685 ↗
  • 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. PubMed 1732479 ↗
  • 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. PubMed 16140901 ↗
  • 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. PubMed 7485317 ↗
  • 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. PubMed 9764623 ↗
  • 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. PubMed 17623581 ↗
  • 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. PubMed 23726817 ↗
  • 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. PubMed 14456322 ↗
  • 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. PubMed 2187347 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2019; primary completion for Dec 2019, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2019
First posted
Jan 25, 2019
StartEst.
Feb 2019
Primary completionEst.
Dec 2019
CompletionEst.
Feb 2020
Last update
Jan 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03815968
Responsible party
Michal Levy, MD (Principal Investigator, Wolfson Medical Center) — Principal investigator
First posted
Jan 25, 2019
Start date
Feb 2019 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Feb 2020 (estimated)
Last update
Jan 25, 2019

Study contacts

Michal Levy, MD
Contact
levmichal@gmail.com
0528591994
Eran Weiner, MD
Contact
eranweiner.md@gmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion