Antalya Training and Research Hospital
Antalya, Muratpaşa, 07100, Turkey (Türkiye)
NCT Number: NCT05332015
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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Notify Me18 year and older
Female
Interventional
Not applicable
Antalya, Muratpaşa, 07100, Turkey (Türkiye)
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
orally given daily two liters of distilled water
orally given daily two liters of normal water
Time frame: admission, day 7
The change between the basal amniotic fluid index and the value on day 7
Antalya Training and Research Hospital
Other Gov
The Effect of Oral Hypotonic Hydration in Pregnant Women With Isolated Oligohydramnios: a Randomized Controlled Study
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