Clinical trial NCT05596812: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Feasibility of the novel risk stratification screening tool
timeFrame: 2 years
Secondary outcomes:
measure: Performance of the GDM risk stratification tool
timeFrame: 2 years
measure: Glycemic control - blood glucose (units)
timeFrame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
measure: Glycemic control - blood glucose (percent above target)
timeFrame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
measure: Gestational weight gain
timeFrame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
measure: Development of hypertensive disorders of pregnancy
timeFrame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
measure: Delivery outcomes - gestational age at delivery
timeFrame: recorded at time of delivery
measure: Delivery outcomes - mode of delivery
timeFrame: recorded at time of delivery
measure: Neonatal outcomes - size for gestational age
timeFrame: recorded at time of delivery
measure: Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
timeFrame: recorded at delivery (at 1 minute and 5 minutes of age)
measure: Health service outcomes - health resource utilization
timeFrame: 2 years
measure: Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)
timeFrame: 2 years; administered to each participant at 6-weeks postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital (Unity Health Toronto)
state: Ontario
Study officials:
References: