The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios
Primary Purpose
Oligohydramnios
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hypotonic (distilled) water
Normal water
Sponsored by
About this trial
This is an interventional treatment trial for Oligohydramnios focused on measuring Oligohydramnios, Hydrotherapy, Hypotonic hydrotherapy
Eligibility Criteria
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)
Sites / Locations
- Antalya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral hydration with normal water
Oral hydration with distilled water
Arm Description
Oral hydration with drinkable normal water daily additional 2 liters for 5 days
Oral hydration with distilled water daily 2 liters for 5 days
Outcomes
Primary Outcome Measures
Number of Participants With Reversal of Oligohydramnios Using AFV Measures
The change between the basal amniotic fluid index and the value on day 7
Secondary Outcome Measures
Full Information
NCT ID
NCT05332015
First Posted
March 31, 2022
Last Updated
January 31, 2023
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05332015
Brief Title
The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios
Official Title
The Effect of Oral Hypotonic Hydration in Pregnant Women With Isolated Oligohydramnios: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
August 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligohydramnios
Keywords
Oligohydramnios, Hydrotherapy, Hypotonic hydrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral hydration with normal water
Arm Type
Active Comparator
Arm Description
Oral hydration with drinkable normal water daily additional 2 liters for 5 days
Arm Title
Oral hydration with distilled water
Arm Type
Active Comparator
Arm Description
Oral hydration with distilled water daily 2 liters for 5 days
Intervention Type
Other
Intervention Name(s)
Hypotonic (distilled) water
Intervention Description
orally given daily two liters of distilled water
Intervention Type
Other
Intervention Name(s)
Normal water
Intervention Description
orally given daily two liters of normal water
Primary Outcome Measure Information:
Title
Number of Participants With Reversal of Oligohydramnios Using AFV Measures
Description
The change between the basal amniotic fluid index and the value on day 7
Time Frame
admission, day 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
State/Province
Muratpaşa
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26658482
Citation
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.
Results Reference
background
PubMed Identifier
1945215
Citation
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.
Results Reference
background
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The Effect of Oral Hypotonic Hydration in Isolated Oligohydramnios
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