Study of Maternal Hydration on the Increase of Amniotic Fluid Index
NCT ID: NCT00635947
Last Updated: 2008-03-14
Study Results
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Basic Information
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COMPLETED
PHASE4
99 participants
INTERVENTIONAL
1998-07-31
2005-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1
isotonic solution - 1.5L
isotonic solution
1.5 L- during 2-4hours
2
water- 1.5L
water
1.5 L- during 2-4hours
3
water-200mL
water
200mL- during 2-4hours
Interventions
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isotonic solution
1.5 L- during 2-4hours
water
1.5 L- during 2-4hours
water
200mL- during 2-4hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* singleton pregnancy
* intact membranes
* initial AF index between 5 and 95 per cent
Exclusion Criteria
* no fetal structural malformation
* no evidence of fetal distress on nonstress test
FEMALE
Yes
Sponsors
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UPECLIN HC FM Botucatu Unesp
OTHER
Responsible Party
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Department of Obstetrics and Gynaecology - Botucatu Medical School, UNESP
Principal Investigators
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Vera M Borges, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Medicine of Botucatu--São Paulo State University (Unesp)
Locations
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School of Medicine of Botucatu--São Paulo State University (Unesp)--
Botucatu, São Paulo, Brazil
Countries
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References
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Kilpatrick SJ, Safford KL, Pomeroy T, Hoedt L, Scheerer L, Laros RK. Maternal hydration increases amniotic fluid index. Obstet Gynecol. 1991 Dec;78(6):1098-102.
Kilpatrick SJ, Safford KL. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. Obstet Gynecol. 1993 Jan;81(1):49-52.
Other Identifiers
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upeclin/HC/FMB-Unesp-08
Identifier Type: -
Identifier Source: org_study_id
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