Gestational Diabetes Mellitus and Neurodevelopment in Newborns

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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Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change in neurodevelopment

Time frame: At birth

Evaluate change in neurodevelopment with GDM

Secondary outcomes

Change in DHA level in cord blood

Time frame: At birth

Evaluate change in DHA level with GDM

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?

Important dates

Study start: 2013
Primary completion: 2014
First posted: May 20, 2016
Registry last updated: May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed