Study of Maternal Hydration on the Increase of Amniotic Fluid Index

Phase 4

Completed

• Conditions: Pregnancy

• Registration Number: NCT00635947
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief 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.

Study Timeline

• Study Start: 1998-07
• Primary Completion: 1999-07
• Study Completion: 2005-01
• Status Verified: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Last Update Submitted: 2008-03-13
• Study First Posted: 2008-03-14
• Last Update Posted: 2008-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios	4horas

Secondary Outcome Measures

Name	Time	Method
compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios	4horas

Trial Locations

Locations (1)

School of Medicine of Botucatu--São Paulo State University (Unesp)--; 🇧🇷 Botucatu, São Paulo, Brazil