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Completed

NCT Number: NCT05332015

The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

About this study

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.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Hypotonic (distilled) water

Other

orally given daily two liters of distilled water

normal water

Other

orally given daily two liters of normal water

Primary outcomes

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

    Time frame: admission, day 7

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

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Oral Hypotonic Hydration in Pregnant Women With Isolated Oligohydramnios: a Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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