- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308359
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 Contact
- Name: Ariel Many, MD
- Phone Number: 97236925633
- Email: many@post.tau.ac.il
Study Contact Backup
- Name: NAdav Mishan, MD
- Phone Number: 97236925633
- Email: nadavmi@gmail.com
Study Locations
-
-
-
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%
|
500 ml glucose 5% within 30 minutes
|
Active Comparator: 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
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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