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Trials / Completed

CompletedNCT02779452

Gestational Diabetes Mellitus and Neurodevelopment in Newborns

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

Status
Completed
Phase
Study type
Observational
Enrollment
46 (actual)
Sponsor
Université de Sherbrooke · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2013-12-01
Primary completion
2014-11-01
First posted
2016-05-20
Last updated
2016-05-20

Source: ClinicalTrials.gov record NCT02779452. Inclusion in this directory is not an endorsement.

Gestational Diabetes Mellitus and Neurodevelopment in Newborns (NCT02779452) · Clinical Trials Directory