Gestational Diabetes Mellitus in Pregnancy
Conditions
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.
Interventions
OTHERNew Care Pathway
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the novel risk stratification screening tool | 2 years | number of patients screened, recruited, consented and randomized as documented in the study recruitment log |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control - blood glucose (percent above target) | approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum) | percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) |
| Gestational weight gain | approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum) | in kilograms (kg) |
| Development of hypertensive disorders of pregnancy | approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum) | documented as recorded from patient charts (Yes/No) |
| Performance of the GDM risk stratification tool | 2 years | 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. |
| Delivery outcomes - gestational age at delivery | recorded at time of delivery | measured in weeks |
| Glycemic control - blood glucose (units) | approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum) | mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL |
| Neonatal outcomes - size for gestational age | recorded at time of delivery | measured in grams |
| Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score | recorded at delivery (at 1 minute and 5 minutes of age) | 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 | 2 years | total number of care encounters (categorized by department - endocrine, obstetric) |
| Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18) | 2 years; administered to each participant at 6-weeks postpartum | 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. |
| Delivery outcomes - mode of delivery | recorded at time of delivery | vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined |
Countries
Canada
Contacts
Primary ContactHoward Berger, MD
Backup ContactKlaudia Szczech
Outcome results
None listed