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Clinical Trials/NCT00635947
NCT00635947CompletedPhase 4

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

UPECLIN HC FM Botucatu Unesp2 sites in 1 country99 target enrollmentStarted: July 1, 1998Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
99
Locations
2
Primary Endpoint
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios

Time Frame: 4horas

Secondary Outcomes

  • compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios(4horas)

Investigators

Sponsor
UPECLIN HC FM Botucatu Unesp
Sponsor Class
Other

Study Sites (2)

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