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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02779452

Enrollment

Registered

2016-05-20

Start date

2013-12-31

Completion date

Unknown

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Glucose Metabolism Disorders

Keywords

neurodevelopment, electroencephalography, gestational diabetes mellitus, omega 3 polyunsaturated fatty acids

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in neurodevelopment	At birth	Evaluate change in neurodevelopment with GDM

Secondary

Measure	Time frame	Description
Change in DHA level in cord blood	At birth	Evaluate change in DHA level with GDM

Outcome results