The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios
NCT ID: NCT05332015
Last Updated: 2023-02-01
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-04-28
2022-08-28
Brief Summary
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HYPOTHESIS: İsolated oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed better with orally hypotonic water.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral hydration with normal water
Oral hydration with drinkable normal water daily additional 2 liters for 5 days
Hypotonic (distilled) water
orally given daily two liters of distilled water
Oral hydration with distilled water
Oral hydration with distilled water daily 2 liters for 5 days
Normal water
orally given daily two liters of normal water
Interventions
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Hypotonic (distilled) water
orally given daily two liters of distilled water
Normal water
orally given daily two liters of normal water
Eligibility Criteria
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Inclusion Criteria
* 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 maternal systemic disease (nephropathy, cardiac disease)
* Multiple pregnancies
* Conditions in which the amount of amniotic fluid cannot be accurately assessed (morbid obesity)
18 Years
FEMALE
No
Sponsors
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Antalya Training and Research Hospital
OTHER_GOV
Responsible Party
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Burak Karadag, MD
Associate Professor
Locations
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Antalya Training and Research Hospital
Antalya, Muratpaşa, Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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4/2
Identifier Type: -
Identifier Source: org_study_id
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