Use of Glucose and Saline for Fetal Movement Perception

March 3, 2011 updated by: Tel-Aviv Sourasky Medical Center

Impact of Glucose Administration on Perception of Fetal Movements

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
        • Contact:
          • Ariel Many, MD
          • Phone Number: 97236925633
        • Contact:
          • Nadav Mishan, MD
          • Phone Number: 97236925633
        • Principal Investigator:
          • Ariel Many, MD
        • Sub-Investigator:
          • Nadav Mishan, MD

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy parturients with singleton pregnancy during 3rd trimester

Exclusion Criteria:

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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glucose 5%
Drug: IV glucose 5%
500 ml glucose 5% within 30 minutes
Active Comparator: saline
Drug: saline
saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal movements as perceived by the mother
Time Frame: one hour
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

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Ariel Many, MD, Lis Maternity Hospital

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

January 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-10-am-0512-CTIL

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.

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