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CompletedNCT05332015Updated Feb 1, 2023

The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios

An interventional study of Hypotonic (distilled) water and Normal water in Oligohydramnios, sponsored by Antalya Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Antalya Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

OBJECTIVE: The primary objective of our study is to compare the effects of routine hydration with additional 2 liters of normal water versus orally 2 liters of distilled water on the amount of amniotic fluid.

HYPOTHESIS: İsolated oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed better with orally hypotonic water.

Read the detailed description

BACKGROUND: Olygohydramniosis is a condition in which amniotic fluid levels are lower than expected for gestational age. It is typically diagnosed by ultrasound examination and may be described qualitatively (e.g., reduced amniotic fluid volume) or quantitatively (e.g., amniotic fluid index ≤5 cm, single deepest pocket \<2 cm). Water hydration aims to decrease maternal osmolality and sodium concentration, increase water flow osmotically from maternal blood to fetal amniotic fluid, and improve uteroplacental perfusion.

A meta-analysis comparing maternal hydration's effect reported that maternal intravenous hydration had good results on AFI in pregnancies with isolated oligohydramnios and hypotonic solutions were more effective than isotonic fluids(1). Maternal oral hydration may slightly increase amniotic fluid and is safer than intravenous fluid administration or amnioinfusion.

Reducing the osmolality in maternal blood with oral hypotonic and isotonic fluids helps to direct the placental water passage towards the fetus, to improve uteroplacental perfusion, and as a result, to increase the amount of amniotic fluid in pregnant women with isolated oligohydramnios. Osmolality is further reduced by maternal oral hypotonic fluid, thus improving the amount of amniotic fluid.

The study protocol was approved by the Local Ethics Committee, and written informed consent will be taken from patients entering the study. The sample size was calculated based on the "Maternal hydration increases amniotic fluid index" study of Kilpatrick et al.(2). When 1.5 cm increase in AFI is considered significant, with 90% power and type 2 error (alpha): 0.05, the sample size is 20 for each group, and it is planned to include 40 pregnant women in total.

I

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Conditions studied

  • Oligohydramnios

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Keywords

  • Oligohydramnios
  • Hydrotherapy
  • Hypotonic hydrotherapy
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In context

Oligohydramnios

26 studies on the registry are indexed under Oligohydramnios; 4 are open to participants now.

This study's enrollment of 40 is below the median of 91 across 16 interventional studies indexed under Oligohydramnios.

Browse Oligohydramnios studies →

Lead sponsor

Antalya Training and Research Hospital is the lead sponsor of 104 studies on the registry; 12 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Singleton pregnancy
  • Gestational age (GA) 28-39 weeks (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
  • Isolated oligohydramnios cases
  • Amniotic fluid index ≤ 5
  • No pregnancy complications such as preeclampsia, gestational hypertension
  • Intact fetal membranes.

Exclusion criteria

Exclusion Criteria:

  • Presence of fetal complications (membrane rupture, presence of fetal anomaly, intrauterine growth restriction)
  • Presence of maternal systemic disease (nephropathy, cardiac disease)
  • Multiple pregnancies
  • Conditions in which the amount of amniotic fluid cannot be accurately assessed (morbid obesity)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Oral hydration with normal water

    Oral hydration with drinkable normal water daily additional 2 liters for 5 days

    Other: Hypotonic (distilled) water

  • Active comparator
    Oral hydration with distilled water

    Oral hydration with distilled water daily 2 liters for 5 days

    Other: Normal water

Interventions

  • OtherHypotonic (distilled) water

    orally given daily two liters of distilled water

  • OtherNormal water

    orally given daily two liters of normal water

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What researchers measure

Primary outcomes

  1. Number of Participants With Reversal of Oligohydramnios Using AFV Measures

    The change between the basal amniotic fluid index and the value on day 7

    Time frame: admission, day 7

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Study locations

1 site
  • Antalya Training and Research Hospital
    Antalya, Muratpaşa 07100, Turkey (Türkiye)
08

References and documents

Publications

  • Gizzo S, Noventa M, Vitagliano A, Dall'Asta A, D'Antona D, Aldrich CJ, Quaranta M, Frusca T, Patrelli TS. An Update on Maternal Hydration Strategies for Amniotic Fluid Improvement in Isolated Oligohydramnios and Normohydramnios: Evidence from a Systematic Review of Literature and Meta-Analysis. PLoS One. 2015 Dec 11;10(12):e0144334. doi: 10.1371/journal.pone.0144334. eCollection 2015. PubMed 26658482 ↗
  • Kilpatrick SJ, Safford KL, Pomeroy T, Hoedt L, Scheerer L, Laros RK. Maternal hydration increases amniotic fluid index. Obstet Gynecol. 1991 Dec;78(6):1098-102. PubMed 1945215 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05332015
Responsible party
Burak Karadag, MD (Associate Professor, Antalya Training and Research Hospital) — Principal investigator
First posted
Apr 18, 2022
Start date
Apr 28, 2022
Primary completion
Jun 28, 2022
Completion
Aug 28, 2022
Last update
Feb 1, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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