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Use of Glucose and Saline for Fetal Movement Perception

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01308359
First received: December 14, 2010
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention
Fetal Movement Perception
 Drug: IV glucose 5%
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Glucose Administration on Perception of Fetal Movements

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • fetal movements as perceived by the mother [ Time Frame: one hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glucose 5%
glucose 5%
 Drug: IV glucose 5%
500 ml glucose 5% within 30 minutes
Active Comparator: saline
saline
 Drug: saline
saline

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy parturients with singleton pregnancy during 3rd trimester

Exclusion Criteria:

  • Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308359

Contacts
Contact: Ariel Many, MD 97236925633 many@post.tau.ac.il
Contact: NAdav Mishan, MD 97236925633 nadavmi@gmail.com

Locations
Israel
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Ariel Many, MD     97236925633        
Contact: Nadav Mishan, MD     97236925633        
Principal Investigator: Ariel Many, MD            
Sub-Investigator: Nadav Mishan, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ariel Many, MD Lis Maternity Hospital
  More Information

No publications provided

Responsible Party: Ariel Many, MD, Dep. of OB&GYN, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01308359     History of Changes
Other Study ID Numbers: TASMC-10-am-0512-CTIL
Study First Received: December 14, 2010
Last Updated: March 3, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
fetal movement

ClinicalTrials.gov processed this record on June 17, 2013