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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
150
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
St. Michael's Hospital (Unity Health Toronto)
Toronto, Ontario, Canada
RECRUITINGFeasibility of the novel risk stratification screening tool
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
Time frame: 2 years
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.
Time frame: 2 years
Glycemic control - blood glucose (units)
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)
Glycemic control - blood glucose (percent above target)
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)
Gestational weight gain
in kilograms (kg)
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Development of hypertensive disorders of pregnancy
documented as recorded from patient charts (Yes/No)
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Delivery outcomes - gestational age at delivery
measured in weeks
Time frame: recorded at time of delivery
Delivery outcomes - mode of delivery
vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined
Time frame: recorded at time of delivery
Neonatal outcomes - size for gestational age
measured in grams
Time frame: recorded at time of delivery
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.
Time frame: recorded at delivery (at 1 minute and 5 minutes of age)
Health service outcomes - health resource utilization
total number of care encounters (categorized by department - endocrine, obstetric)
Time frame: 2 years
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.
Time frame: 2 years; administered to each participant at 6-weeks postpartum
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