NCT01308359

Brief Summary

The purpose of this study is to investigate the hypothesis that glucose administration increases fetal movement perception by the pregnant woman.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

December 14, 2010

Last Update Submit

March 3, 2011

Conditions

Fetal Movement Perception

Keywords

fetal movement

Outcome Measures

Primary Outcomes (1)

  • fetal movements as perceived by the mother

    Effect of glucose versus saline infusion on the perception of fetal movements. the mother will count fetal movements that she feels one hour following saline/glucose infusion and report to the obstetrician in charge. The research aims to clarify whether glucose increases fetal movements.

    one hour

Study Arms (2)

glucose 5%

EXPERIMENTAL

glucose 5%

Drug: IV glucose 5%

saline

ACTIVE COMPARATOR

saline

Drug: saline

Interventions

IV glucose 5%DRUG

500 ml glucose 5% within 30 minutes

glucose 5%
salineDRUG

saline

saline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy parturients with singleton pregnancy during 3rd trimester

You may not qualify if:

  • Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ariel Many, MD

    Lis Maternity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Many, MD

CONTACT

97236925633many@post.tau.ac.il

NAdav Mishan, MD

CONTACT

97236925633nadavmi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 14, 2010

First Posted

March 4, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations

IL(1)