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Completed

NCT Number: NCT00635947

Study of Maternal Hydration on the Increase of Amniotic Fluid Index

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

School of Medicine of Botucatu--São Paulo State University (Unesp)--

Botucatu, São Paulo, 18600, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotonic solution

Other

1.5 L- during 2-4hours

Other names: Isotonic

Water

Other

1.5 L- during 2-4hours

Other names: Water 1.5

Primary outcomes

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

    Time frame: 4horas

Secondary outcomes

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

    Time frame: 4horas

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
Study completion
2005
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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