Effect of Caffeine on Gestational Diabetes Screening
| ISRCTN | ISRCTN90645333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90645333 |
| Protocol serial number | N/A |
| Sponsor | Canadian Foundation for Women's Health |
| Funder | Canadian Foundation for Women's Health |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Caffeine |
| Primary outcome measure(s) |
Maternal blood glucose |
| Key secondary outcome measure(s) |
1. Maternal plasma insulin, C-peptide, catecholamines, methylxanthines, free fatty acids, glycerol, lactate, and electrolytes |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
