Gestational Diabetes Mellitus and Neurodevelopment in Newborns

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779452
• Other study ID #: GDM and neurodevelopment
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: May 18, 2016
• Start date: December 2013

Study information

• Verified date: May 2016
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• Glucose Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neurodevelopment	Evaluate change in neurodevelopment with GDM	At birth	No
Secondary	Change in DHA level in cord blood	Evaluate change in DHA level with GDM	At birth	No