NCT00635947

Study of Maternal Hydration on the Increase of Amniotic Fluid Index

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: UPECLIN HC FM Botucatu Unesp · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
OTHER	isotonic solution	1.5 L- during 2-4hours
OTHER	water	1.5 L- during 2-4hours
OTHER	water	200mL- during 2-4hours

Timeline

• Start date: 1998-07-01
• Primary completion: 1999-07-01
• Completion: 2005-01-01
• First posted: 2008-03-14
• Last updated: 2008-03-14

Locations

1 site across 1 country: Brazil