Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

NCT03815968 | Unknown

• 1 other identifier: 0008-19-WOMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Oligohydramnios

Keywords

oligohydroamnios; low salt diet

Outcome Measures

Primary Outcomes (1)

• amniotic fluid volume, assessed by ultrasound

  amniotic fluid volume after two weeks

  two weeks

Secondary Outcomes (4)

• gestational age at birth

  up to 18 weeks (until delivery)

• induction of labor

  up to 18 weeks (until delivery)

• labor type

  up to 18 weeks (until delivery)

• Pregnancy and childbirth complications

  up to 18 weeks (until delivery)

Study Arms (2)

low sodium diet

EXPERIMENTAL

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

Other: low sodium diet

regular diet

NO INTERVENTION

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

Interventions

low sodium diet OTHER

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

low sodium diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University

Holon, 6404519, Israel

Location

Related Publications (10)

• 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.

  PMID: 27062200 RESULT

• 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.

  PMID: 11441685 RESULT

• 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.

  PMID: 1732479 RESULT

• 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.

  PMID: 16140901 RESULT

• 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.

  PMID: 7485317 RESULT

• 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.

  PMID: 9764623 RESULT

• 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.

  PMID: 17623581 RESULT

• 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.

  PMID: 23726817 RESULT

• 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.

  PMID: 14456322 RESULT

• 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.

  PMID: 2187347 RESULT

MeSH Terms

Conditions

Oligohydramnios

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Michal Levy, MD

CONTACT

0528591994; levmichal@gmail.com

Eran Weiner, MD

CONTACT

eranweiner.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 25, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)