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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01308359
Other study ID # TASMC-10-am-0512-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received December 14, 2010
Last updated March 3, 2011
Start date January 2011
Est. completion date January 2012

Study information

Verified date March 2011
Source Tel-Aviv Sourasky Medical Center
Contact Ariel Many, MD
Phone 97236925633
Email many@post.tau.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy parturients with singleton pregnancy during 3rd trimester

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
IV glucose 5%
500 ml glucose 5% within 30 minutes
saline
saline

Locations

Country Name City State
Israel Lis Maternity Hospital, Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No