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
  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:


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 April 17, 2014