Trial | NCT00635947  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    99
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.
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 Started
Jul 31
1998
Primary Completion
Jul 31
1999
Study Completion
Jan 31
2005
Last Update
Mar 14
2008
Estimate

Other isotonic solution

1.5 L- during 2-4hours

  • Other names: Isotonic

Other water

1.5 L- during 2-4hours

  • Other names: Water 1.5

Other water

200mL- during 2-4hours

  • Other names: Water 200

1 Active Comparator

isotonic solution - 1.5L

2 Active Comparator

water- 1.5L

3 Placebo Comparator

water-200mL

Criteria 

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
No Results Posted