A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Sponsor
- Unity Health Toronto
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Feasibility of the novel risk stratification screening tool
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Feasibility of the novel risk stratification screening tool
Time Frame: 2 years
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
Secondary Outcomes
- Gestational weight gain(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Development of hypertensive disorders of pregnancy(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Delivery outcomes - mode of delivery(recorded at time of delivery)
- Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score(recorded at delivery (at 1 minute and 5 minutes of age))
- Performance of the GDM risk stratification tool(2 years)
- Glycemic control - blood glucose (units)(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Glycemic control - blood glucose (percent above target)(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Neonatal outcomes - size for gestational age(recorded at time of delivery)
- Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)(2 years; administered to each participant at 6-weeks postpartum)
- Delivery outcomes - gestational age at delivery(recorded at time of delivery)
- Health service outcomes - health resource utilization(2 years)