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
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.
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
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.
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Exclusion Criteria:
Oral hydration with drinkable normal water daily additional 2 liters for 5 days
Other: Hypotonic (distilled) water
Oral hydration with distilled water daily 2 liters for 5 days
Other: Normal water
orally given daily two liters of distilled water
orally given daily two liters of normal water
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
Plan to share: No
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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