Effect of Caffeine on Gestational Diabetes Screening
| ISRCTN | ISRCTN90645333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90645333 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/09/2005
- Registration date
- 21/11/2005
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Graeme Smith
Scientific
Scientific
Department of Obstetrics & Gynecology
Kingston General Hospital
76 Stuart St.
Kingston
K7L 2V7
Canada
| Phone | +1 6135482405 |
|---|---|
| gns@post.queensu.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Scientific title | Effect of Caffeine on Gestational Diabetes Screening |
| Study objectives | We hypothesize that maternal caffeine ingestion has an adverse impact on screening for Gestational Diabetes Mellitus (GDM). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gestational Diabetes |
| Intervention | Effect of Caffeine versus placebo on 75 g oral glucose tolerance test results |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Caffeine |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Total final enrolment | 27 |
| Key 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 |
| Key exclusion criteria | As per inclusion criteria |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/12/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Obstetrics & Gynecology
Kingston
K7L 2V7
Canada
K7L 2V7
Canada
Sponsor information
Canadian Foundation for Women's Health
Charity
Charity
78 Echo Drive
Ottawa
K1S5R7
Canada
| Phone | +1 6137304192 |
|---|---|
| kmacgowan@sogc.com | |
| Website | http://www.cfwh.org/index_e.html |
"ROR" |
https://ror.org/0278syk25 |
Funders
Funder type
Charity
Canadian Foundation for Women's Health
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | 12/01/2021 | Yes | No |
Editorial Notes
12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
