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Gestational Diabetes Mellitus and Neurodevelopment in Newborns

U

Université de Sherbrooke

Status

Completed

Conditions

Diabetes, Gestational
Glucose Metabolism Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT02779452
GDM and neurodevelopment

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

46 participants in 2 patient groups

GDM newborns
Description:
Newborns from gestational diabetes mellitus pregnancy
No GDM newborns
Description:
Newborn from a normal pregnancy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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