Diabetes, GestationalNCT02779452
Gestational Diabetes Mellitus and Neurodevelopment in Newborns
An observational study of Diabetes, Gestational and Glucose Metabolism Disorders, run by Université de Sherbrooke.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational, Glucose Metabolism Disorders
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with singleton pregnancy were recruited in the Centre Hospitalier Universitaire de Sherbrooke (CHUS) at 24 - 28 weeks of gestation.
Who may be able to join
- singleton pregnancy
- aged between 18 and 40 years
Who cannot join
- smoking,
- illicit drug consumption,
- omega-3/6 consumption,
- liver or renal disease,
- cancer
- any medical conditions affecting glucose/lipid metabolism.
About this study
Official title: Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?
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.
Read the 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.
- Keywords
- neurodevelopment, electroencephalography, gestational diabetes mellitus, omega 3 polyunsaturated fatty acids
- Medical subject headings
- Diabetes, Gestational, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GDM newborns | Newborns from gestational diabetes mellitus pregnancy | |
| No GDM newborns | Newborn from a normal pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurodevelopment
Evaluate change in neurodevelopment with GDM
Measured: At birth
Secondary outcomes (1)
Change in DHA level in cord blood
Evaluate change in DHA level with GDM
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startDec 2013
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Plourde, Université de Sherbrooke
- Investigators
- Mélanie Plourde, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779452
- Sponsor's protocol ID
- GDM and neurodevelopment
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?
- ClinicalTrials.gov ID
- NCT02779452
- Acronym / sponsor ID
- GDM and neurodevelopment
- Keywords
- neurodevelopment, electroencephalography, gestational diabetes mellitus, omega 3 polyunsaturated fatty acids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM newborns | – | –Newborns from gestational diabetes mellitus pregnancy |
| No GDM newborns | – | –Newborn from a normal pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with singleton pregnancy were recruited in the Centre Hospitalier Universitaire de Sherbrooke (CHUS) at 24 - 28 weeks of gestation.
Key inclusion criteria (2 listed)
- singleton pregnancy
- aged between 18 and 40 years
Key exclusion criteria (6 listed)
- smoking,
- illicit drug consumption,
- omega-3/6 consumption,
- liver or renal disease,
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in neurodevelopment
Time frame: At birth
Evaluate change in neurodevelopment with GDM
1 secondary outcome
Change in DHA level in cord blood
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Plourde, PhD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational and Glucose Metabolism Disorders, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurodevelopment (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.