Clinical trial NCT00635947: Study of Maternal Hydration on the Increase of Amniotic Fluid Index
Official title: Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Amniotic fluid index
maternal hydration
isotonic solution
Amniotic Fluid
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 99
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
timeFrame: 4horas
Secondary outcomes:
measure: compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
timeFrame: 4horas
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: School of Medicine of Botucatu--São Paulo State University (Unesp)--
state: São Paulo
Study officials:
affiliation: School of Medicine of Botucatu--São Paulo State University (Unesp)
name: Vera M Borges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kilpatrick SJ, Safford KL. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. Obstet Gynecol. 1993 Jan;81(1):49-52.