Gestational Diabetes Mellitus and Neurodevelopment in Newborns

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

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the feasibility of using a quantitative EEG method to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM) compared to control newborns.

The second purpose of this study is to determine whether cord blood concentration in docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate whether this contributes to neonates neurodevelopment status.

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Detailed Description

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Maternal weight is measured close to delivery and BMI is calculated. Birth weight, length, head circumference, Apgar score and glycaemia are recorded at birth. An EEG are performed on the newborn within 48 hrs after birth.A maternal blood sample is collected at admission to measure maternal glycated hemoglobin (A1C). Cord blood samples are collected in the umbilical vein after delivery.

Conditions

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Diabetes, Gestational Glucose Metabolism Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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GDM newborns

Newborns from gestational diabetes mellitus pregnancy

No interventions assigned to this group

No GDM newborns

Newborn from a normal pregnancy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* aged between 18 and 40 years

Exclusion Criteria

* smoking,
* illicit drug consumption,
* omega-3/6 consumption,
* liver or renal disease,
* cancer
* any medical conditions affecting glucose/lipid metabolism.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes