NCT00635947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P25-P50 for phase_4 pregnancy

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1999

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

1 year

First QC Date

March 7, 2008

Last Update Submit

March 13, 2008

Conditions

Pregnancy

Keywords

Amniotic fluid indexmaternal hydrationisotonic solutionAmniotic Fluid

Outcome Measures

Primary Outcomes (1)

  • the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios

    4horas

Secondary Outcomes (1)

  • compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios

    4horas

Study Arms (3)

1

ACTIVE COMPARATOR

isotonic solution - 1.5L

Other: isotonic solution

2

ACTIVE COMPARATOR

water- 1.5L

Other: water

3

PLACEBO COMPARATOR

water-200mL

Other: water

Interventions

isotonic solutionOTHER

1.5 L- during 2-4hours

Also known as: Isotonic
1
waterOTHER

1.5 L- during 2-4hours

Also known as: Water 1.5
2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • gestational age between 33 and 36 weeks
  • singleton pregnancy
  • intact membranes
  • initial AF index between 5 and 95 per cent

You may not qualify if:

  • no maternal complications
  • no fetal structural malformation
  • no evidence of fetal distress on nonstress test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine of Botucatu--São Paulo State University (Unesp)--

Botucatu, São Paulo, 18600, Brazil

Location

Related 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.

    PMID: 1945215RESULT

  • Kilpatrick SJ, Safford KL. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. Obstet Gynecol. 1993 Jan;81(1):49-52.

    PMID: 8416460RESULT

MeSH Terms

Interventions

Isotonic SolutionsWater

Intervention Hierarchy (Ancestors)

SolutionsPharmaceutical PreparationsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Vera M Borges, PhD

    School of Medicine of Botucatu--São Paulo State University (Unesp)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

July 1, 1998

Primary Completion

July 1, 1999

Study Completion

January 1, 2005

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

BR(1)