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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women able to understand and sign the study consent form
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years; administered to each participant at 6-weeks postpartum
Awards & highlights
Study Summary
This trial studies a new screening tool and care pathway for pregnant women w/ GDM, to measure its effects on glycemic control, perinatal outcomes & health resource use.
Who is the study for?
This trial is for pregnant women diagnosed with low-risk gestational diabetes between 24-32 weeks, who can sign the consent form and plan to give birth at St. Michael's Hospital. It excludes those with preexisting diabetes, multiple pregnancies, or GDM diagnosis outside of the specified timeframe.Check my eligibility
What is being tested?
The study tests a new care pathway for managing low-risk gestational diabetes using a risk stratification tool. It aims to see how this approach affects blood sugar control, childbirth outcomes like baby size and delivery method, and healthcare resource use.See study design
What are the potential side effects?
Since this trial involves a new care management pathway rather than medication, side effects are not typical as in drug trials but may include varying levels of stress or inconvenience due to different treatment protocols.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study and have signed the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years; administered to each participant at 6-weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years; administered to each participant at 6-weeks postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the novel risk stratification screening tool
Secondary outcome measures
Delivery outcomes - gestational age at delivery
Delivery outcomes - mode of delivery
Development of hypertensive disorders of pregnancy
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (Risk Stratification Pathway)Experimental Treatment1 Intervention
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.
Group II: Control (Routine Care)Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
535 Previous Clinical Trials
446,933 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with gestational diabetes before 24 weeks or after 32 weeks of pregnancy, or I am carrying more than one baby.I am a woman with diabetes (Type 1 or 2).You are pregnant with one baby.You were diagnosed with gestational diabetes between 24 and 32 weeks of pregnancy using specific tests recommended by the Canadian Diabetes Association.You are pregnant with only one baby.I understand the study and have signed the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (Risk Stratification Pathway)
- Group 2: Control (Routine Care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still ongoing?
"Yes, the information on clinicaltrials.gov suggests that this medical trial is actively recruiting patients. This study was first posted on August 23rd 2022 and subsequently updated October 24th of the same year. Currently, 150 participants are being recruited from a single site."
Answered by AI
What is the current size of the cohort participating in this trial?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this research trial, initially posted on August 23rd 2022, is actively recruiting participants. 150 individuals are needed from one medical centre."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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