Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/09/2005
Date assigned
21/11/2005
Last edited
18/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cfwh.org/index_e.html

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

Publication citations

Additional files

Editorial Notes