Back to resultsA Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
New Care Pathway
Sponsored by
About this trial
This is an interventional health services research trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Women able to understand and sign the study consent form
- 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:
- Women with preexisting diabetes (Type 1 or 2 diabetes)
- 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
Sites / Locations
- St. Michael's Hospital (Unity Health Toronto)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (Risk Stratification Pathway)
Control (Routine Care)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility of the novel risk stratification screening tool
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
Secondary Outcome Measures
Performance of the GDM risk stratification tool
With regards to identification of women with GDM who maintain euglycemia on lifestyle modification alone in the "Low-risk GDM" group. Sensitivity, specificity, and accuracy will be calculated.
Glycemic control - blood glucose (units)
mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL
Glycemic control - blood glucose (percent above target)
percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)
Gestational weight gain
in kilograms (kg)
Development of hypertensive disorders of pregnancy
documented as recorded from patient charts (Yes/No)
Delivery outcomes - gestational age at delivery
measured in weeks
Delivery outcomes - mode of delivery
vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined
Neonatal outcomes - size for gestational age
measured in grams
Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score is based on a total score of 1 to 10; The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 or above on the test is considered in good health. A lower score does not mean that the baby is unhealthy, but that the baby may need some immediate medical care, such as suctioning of the airways or oxygen to help him or her breathe better.
Health service outcomes - health resource utilization
total number of care encounters (categorized by department - endocrine, obstetric)
Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)
Short-form Patient Satisfaction Questionnaire (PSQ-18); responses to items are measured on a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Minimum score is 18, maximum score is 90. Higher scores indicate satisfaction with medical care.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05596812
Brief Title
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Official Title
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (GDM), and the implementation of a new low-impact care pathway for women with low-risk GDM. The study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with GDM that are at low-risk of dietary therapy failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention (Risk Stratification Pathway)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Routine Care)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
New Care Pathway
Intervention Description
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
Primary Outcome Measure Information:
Title
Feasibility of the novel risk stratification screening tool
Description
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Performance of the GDM risk stratification tool
Description
With regards to identification of women with GDM who maintain euglycemia on lifestyle modification alone in the "Low-risk GDM" group. Sensitivity, specificity, and accuracy will be calculated.
Time Frame
2 years
Title
Glycemic control - blood glucose (units)
Description
mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL
Time Frame
approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Title
Glycemic control - blood glucose (percent above target)
Description
percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)
Time Frame
approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Title
Gestational weight gain
Description
in kilograms (kg)
Time Frame
approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Title
Development of hypertensive disorders of pregnancy
Description
documented as recorded from patient charts (Yes/No)
Time Frame
approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Title
Delivery outcomes - gestational age at delivery
Description
measured in weeks
Time Frame
recorded at time of delivery
Title
Delivery outcomes - mode of delivery
Description
vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined
Time Frame
recorded at time of delivery
Title
Neonatal outcomes - size for gestational age
Description
measured in grams
Time Frame
recorded at time of delivery
Title
Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Description
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score is based on a total score of 1 to 10; The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 or above on the test is considered in good health. A lower score does not mean that the baby is unhealthy, but that the baby may need some immediate medical care, such as suctioning of the airways or oxygen to help him or her breathe better.
Time Frame
recorded at delivery (at 1 minute and 5 minutes of age)
Title
Health service outcomes - health resource utilization
Description
total number of care encounters (categorized by department - endocrine, obstetric)
Time Frame
2 years
Title
Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)
Description
Short-form Patient Satisfaction Questionnaire (PSQ-18); responses to items are measured on a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Minimum score is 18, maximum score is 90. Higher scores indicate satisfaction with medical care.
Time Frame
2 years; administered to each participant at 6-weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women able to understand and sign the study consent form
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:
Women with preexisting diabetes (Type 1 or 2 diabetes)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howard Berger, MD
Phone
416 864 6060
Ext
2395
Email
Howard.Berger@unityhealth.to
First Name & Middle Initial & Last Name or Official Title & Degree
Klaudia Szczech
Phone
416 867 7460
Ext
49092
Email
klaudia.szczech@unityhealth.to
Facility Information:
Facility Name
St. Michael's Hospital (Unity Health Toronto)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Berger, MD
Phone
416 864 6060
Ext
2395
Email
Howard.Berger@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Klaudia Szczech
Phone
416 867 7460
Ext
49092
Email
Klaudia.Szczech@unityhealth.to
12. IPD Sharing Statement
Learn more about this trial
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
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