Use of Glucose and Saline for Fetal Movement Perception

NCT ID: NCT01308359

Last Updated: 2011-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Fetal Movement Perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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glucose 5%

glucose 5%

Group Type EXPERIMENTAL

IV glucose 5%

Intervention Type DRUG

500 ml glucose 5% within 30 minutes

saline

saline

Group Type ACTIVE_COMPARATOR

saline

Intervention Type DRUG

saline

Interventions

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IV glucose 5%

500 ml glucose 5% within 30 minutes

Intervention Type DRUG

saline

saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy parturients with singleton pregnancy during 3rd trimester

Exclusion Criteria

* Any maternal medical condition (Diabetes, hypertension), multiple pregnancy, fetal anomaly, polyhydramnios
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dep. of OB&GYN, Tel Aviv Sourasky Medical Center

Principal Investigators

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Ariel Many, MD

Role: PRINCIPAL_INVESTIGATOR

Lis Maternity Hospital

Locations

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Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ariel Many, MD

Role: CONTACT

97236925633

NAdav Mishan, MD

Role: CONTACT

97236925633

Facility Contacts

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Ariel Many, MD

Role: primary

97236925633

Nadav Mishan, MD

Role: backup

97236925633

Other Identifiers

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TASMC-10-am-0512-CTIL

Identifier Type: -

Identifier Source: org_study_id

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