NCT02779452

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

May 18, 2016

Last Update Submit

May 18, 2016

Conditions

Diabetes, GestationalGlucose Metabolism Disorders

Keywords

neurodevelopmentelectroencephalographygestational diabetes mellitusomega 3 polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

  • Change in neurodevelopment

    Evaluate change in neurodevelopment with GDM

    At birth

Secondary Outcomes (1)

  • Change in DHA level in cord blood

    At birth

Study Arms (2)

GDM newborns

Newborns from gestational diabetes mellitus pregnancy

No GDM newborns

Newborn from a normal pregnancy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with singleton pregnancy were recruited in the Centre Hospitalier Universitaire de Sherbrooke (CHUS) at 24 - 28 weeks of gestation.

You may qualify if:

  • singleton pregnancy
  • aged between 18 and 40 years

You may not qualify if:

  • smoking,
  • illicit drug consumption,
  • omega-3/6 consumption,
  • liver or renal disease,
  • cancer
  • any medical conditions affecting glucose/lipid metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

cord blood plasma

MeSH Terms

Conditions

Diabetes, GestationalGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mélanie Plourde, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Last Updated

May 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share