Contact information
Type
Scientific
Primary contact
Dr Graeme Smith
ORCID ID
Contact details
Department of Obstetrics & Gynecology
Kingston General Hospital
76 Stuart St.
Kingston
K7L 2V7
Canada
+1 6135482405
gns@post.queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We hypothesize that maternal caffeine ingestion has an adverse impact on screening for Gestational Diabetes Mellitus (GDM).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Gestational Diabetes
Intervention
Effect of Caffeine versus placebo on 75 g oral glucose tolerance test results
Intervention type
Drug
Phase
Not Specified
Drug names
Caffeine
Primary outcome measures
Maternal blood glucose
Secondary outcome measures
1. Maternal plasma insulin, C-peptide, catecholamines, methylxanthines, free fatty acids, glycerol, lactate, and electrolytes
2. Fetal heart rate baseline and accelerations
Overall trial start date
01/10/2005
Overall trial end date
30/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pre-pregnancy body mass index (BMI) less than 30 kg/m^2
2. Non-smoking
3. No medications that could interfere with glucose uptake/metabolism (i.e. insulin, anti-hyperglycemics)
4. No known medical/obstetrical complications
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
As per inclusion criteria
Recruitment start date
01/10/2005
Recruitment end date
30/12/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Obstetrics & Gynecology
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
Canadian Foundation for Women's Health
Sponsor details
78 Echo Drive
Ottawa
K1S5R7
Canada
+1 6137304192
kmacgowan@sogc.com
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Canadian Foundation for Women's Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary