Gestational Diabetes Mellitus and Neurodevelopment in Newborns

Completed

• Conditions: Glucose Metabolism Disorders; Diabetes, Gestational

• Registration Number: NCT02779452
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-11
• Status Verified: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-20
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in neurodevelopment	At birth	Evaluate change in neurodevelopment with GDM

Secondary Outcome Measures

Name	Time	Method
Change in DHA level in cord blood	At birth	Evaluate change in DHA level with GDM