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| Sponsored by: |
UPECLIN HC FM Botucatu Unesp |
|---|---|
| Information provided by: | UPECLIN HC FM Botucatu Unesp |
| ClinicalTrials.gov Identifier: | NCT00635947 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy |
Other: isotonic solution Other: water |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Factorial Assignment, Safety Study |
| Official Title: | Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index |
| Enrollment: | 99 |
| Study Start Date: | July 1998 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | July 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
isotonic solution - 1.5L
|
Other: isotonic solution
1.5 L- during 2-4hours
|
|
2: Active Comparator
water- 1.5L
|
Other: water
1.5 L- during 2-4hours
|
|
3: Placebo Comparator
water-200mL
|
Other: water
200mL- during 2-4hours
|
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, São Paulo | |
| School of Medicine of Botucatu--São Paulo State University (Unesp)-- | |
| Botucatu, São Paulo, Brazil, 18600 | |
| Principal Investigator: | Vera M Borges, PhD | School of Medicine of Botucatu--São Paulo State University (Unesp) |
More Information
| Responsible Party: | Department of Obstetrics and Gynaecology - Botucatu Medical School, UNESP ( Vera Therezinha Medeiros Borges ) |
| Study ID Numbers: | upeclin/HC/FMB-Unesp-08 |
| Study First Received: | March 7, 2008 |
| Last Updated: | March 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00635947 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency |
|
Amniotic fluid index maternal hydration isotonic solution Amniotic Fluid |
