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Recruiting
NCT05596812
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
Conditions: Gestational Diabetes Mellitus in Pregnancy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Unity Health Toronto
Location: Canada
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 formsingleton pregnancyplanning to give birth to at St. Michael's Hospitaldiagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice GuidelinesExclusion Criteria:Women with preexisting diabetes (Type 1 or 2 diabetes)multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestationnot continuing care at St. Michael's Hospital after the DIP clinic visit
Source: ClinicalTrials.gov (NCT05596812). StuddyBuddy aggregates publicly available trial information.