A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy

• Registration Number: NCT05596812
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-28
• Study Start: 2022-08-23
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Delivery outcomes - mode of delivery	recorded at time of delivery	vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined
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.
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.
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
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)
Neonatal outcomes - size for gestational age	recorded at time of delivery	measured in grams
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 - gestational age at delivery	recorded at time of delivery	measured in weeks
Health service outcomes - health resource utilization	2 years	total number of care encounters (categorized by department - endocrine, obstetric)

Trial Locations

Locations (1)

St. Michael's Hospital (Unity Health Toronto); 🇨🇦 Toronto, Ontario, Canada