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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00635947
Enrollment
99
Registered
2008-03-14
Start date
1998-07-31
Completion date
2005-01-31
Last updated
2008-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Amniotic fluid index, maternal hydration, isotonic solution, Amniotic Fluid

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.

Interventions

1.5 L- during 2-4hours

OTHERwater

1.5 L- during 2-4hours

Sponsors

UPECLIN HC FM Botucatu Unesp
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios4horas

Secondary

MeasureTime frame
compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios4horas

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026