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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596812
• Other study ID #: 22-065
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2022
• Source: Unity Health Toronto
• Contact: Howard Berger, MD
• Phone: 416 864 6060
• Email: Howard.Berger[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• New Care Pathway
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital (Unity Health Toronto)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the novel risk stratification screening tool	number of patients screened, recruited, consented and randomized as documented in the study recruitment log	2 years
Secondary	Performance of the GDM risk stratification tool	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.	2 years
Secondary	Glycemic control - blood glucose (units)	mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Secondary	Glycemic control - blood glucose (percent above target)	percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Secondary	Gestational weight gain	in kilograms (kg)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Secondary	Development of hypertensive disorders of pregnancy	documented as recorded from patient charts (Yes/No)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Secondary	Delivery outcomes - gestational age at delivery	measured in weeks	recorded at time of delivery
Secondary	Delivery outcomes - mode of delivery	vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined	recorded at time of delivery
Secondary	Neonatal outcomes - size for gestational age	measured in grams	recorded at time of delivery
Secondary	Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score	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.	recorded at delivery (at 1 minute and 5 minutes of age)
Secondary	Health service outcomes - health resource utilization	total number of care encounters (categorized by department - endocrine, obstetric)	2 years
Secondary	Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)	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.	2 years; administered to each participant at 6-weeks postpartum