Study of Maternal Hydration on the Increase of Amniotic Fluid Index

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.

Detailed Description
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Objective: To determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios. Subjects and Methods: Women with normal AF index and gestational age between the 33 and 36 weeks without maternal complications were randomized into three groups (isotonic solution, water, control). The isotonic solution and water groups were instructed to drink 1.5L of respective solution; the control group was instructed to drink 200mL of water. AF index was measured before and after hydration. The investigator performing the AF index was blinded to the subject's group. Results: Ninety-nine women completed the study without any maternal adverse effects. The mean increase in amniotic fluid index after hydration was significantly greater in the isotonic solution and water groups (12.1mm, p=0.02; 13.1mm, p=0.05; respectively) than the control group (1.4mm, p=0.74). There was no significant difference between the isotonic solution and water groups. Hydration with isotonic solution and water improved the chance of 20% of increase of amniotic fluid index in 10.2 (95% CI 1.9-98.9) and 6.0 (95% CI 1.0-45.5) times respectively. Conclusion: Maternal hydration with isotonic solution or water increased AF index in women with normohydramnios.

Official Title
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Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index

Conditions
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Pregnancy

Intervention / Treatment
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* Other: isotonic solution
* Other: water
* Other: water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age between 33 and 36 weeks singleton pregnancy intact membranes initial AF index between 5 and 95 per cent Exclusion Criteria: no maternal complications no fetal structural malformation no evidence of fetal distress on nonstress test
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>isotonic solution - 1.5L | Other: isotonic solution<br>* 1.5 L- during 2-4hours<br>* Other names: Isotonic;|
| Active Comparator: 2<br>water- 1.5L | Other: water<br>* 1.5 L- during 2-4hours<br>* Other names: Water 1.5;|
| Placebo Comparator: 3<br>water-200mL | Other: water<br>* 200mL- during 2-4hours<br>* Other names: Water 200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios |  | 4horas | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios |  | 4horas | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniotic fluid index, maternal hydration, isotonic solution, Amniotic Fluid