Study of Maternal Hydration on the Increase of Amniotic Fluid Index

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635947
• Other study ID #: upeclin/HC/FMB-Unesp-08
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2008
• Last updated: March 13, 2008
• Start date: July 1998
• Est. completion date: January 2005

Study information

• Verified date: March 2008
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2005
• Est. primary completion date: July 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• isotonic solution
1.5 L- during 2-4hours
• water
1.5 L- during 2-4hours
• water
200mL- during 2-4hours

Locations

Country	Name	City	State
Brazil	School of Medicine of Botucatu--São Paulo State University (Unesp)--	Botucatu	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios		4horas	Yes
Secondary	compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios		4horas	Yes