A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
NCT ID: NCT05596812
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-08-23
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus
NCT06109597
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes
NCT01105455
An RCT to Evaluate Incidence, Cost and Clinical Outcomes Using 75 vs 100g. Screening Methods for Gestational Diabetes
NCT00295659
Early Screening for Gestational Diabetes Mellitus in a Low Risk Population
NCT06704035
Early Gestational Diabetes Screening in the Gravid Obese Woman
NCT01864564
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention (Risk Stratification Pathway)
Those randomized to Intervention (Risk Stratification Pathway) will have their demographic and clinical data entered into the risk stratification screening calculator, and will be assigned to either "Low Risk" (Novel (Low Impact) Care Pathway) or "High Risk" (Routine Care Pathway) groups.
Women in the Routine Care Pathway group will be followed in the DIP clinic according to routine care protocols and will provide bi-weekly glucometer data.
Women in the Novel (Low Impact) Care Pathway group will be followed in the New Care Pathway, which will include continuation of lifestyle and dietary modification, continuation of capillary self blood glucose monitoring, and routine prenatal care.
New Care Pathway
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
Control (Routine Care)
Those randomized to Control (Routine Care) will continue in-person and virtual visits as per routine care protocols. This group will also provide bi-weekly glucometer data.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
New Care Pathway
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* singleton pregnancy
* planning to give birth to at St. Michael's Hospital
* diagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice Guidelines
Exclusion Criteria
* multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestation
* not continuing care at St. Michael's Hospital after the DIP clinic visit
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Unity Health Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Michael's Hospital (Unity Health Toronto)
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-065
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.