Study of Maternal Hydration on the Increase of Amniotic Fluid Index

March 13, 2008 updated by: UPECLIN HC FM Botucatu Unesp

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18600
        • School of Medicine of Botucatu--São Paulo State University (Unesp)--

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
isotonic solution - 1.5L
Other: isotonic solution
1.5 L- during 2-4hours
Other Names:
  • Isotonic
ACTIVE_COMPARATOR: 2
water- 1.5L
Other: water
1.5 L- during 2-4hours
Other Names:
  • Water 1.5
Other: water
200mL- during 2-4hours
Other Names:
  • Water 200
PLACEBO_COMPARATOR: 3
water-200mL
Other: water
1.5 L- during 2-4hours
Other Names:
  • Water 1.5
Other: water
200mL- during 2-4hours
Other Names:
  • Water 200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Time Frame: 4horas
4horas

Secondary Outcome Measures

Outcome Measure
Time Frame
compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Time Frame: 4horas
4horas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Vera M Borges, PhD, School of Medicine of Botucatu--São Paulo State University (Unesp)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (ACTUAL)

July 1, 1999

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (ESTIMATE)

March 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 13, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on isotonic solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe