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.