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

NCT05596812 | Unknown

• 1 other identifier: 22-065
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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)

• 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)

Study Arms (2)

Intervention (Risk Stratification Pathway)

EXPERIMENTAL

Those randomized to Intervention (Risk Stratification Pathway) will have their demographic and clinical data entered into the risk stratification screening calculator, and will be assigned to either "Low Risk" (Novel (Low Impact) Care Pathway) or "High Risk" (Routine Care Pathway) groups. Women in the Routine Care Pathway group will be followed in the DIP clinic according to routine care protocols and will provide bi-weekly glucometer data. Women in the Novel (Low Impact) Care Pathway group will be followed in the New Care Pathway, which will include continuation of lifestyle and dietary modification, continuation of capillary self blood glucose monitoring, and routine prenatal care.

Other: New Care Pathway

Control (Routine Care)

NO INTERVENTION

Those randomized to Control (Routine Care) will continue in-person and virtual visits as per routine care protocols. This group will also provide bi-weekly glucometer data.

Interventions

New Care Pathway OTHER

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

Intervention (Risk Stratification Pathway)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital (Unity Health Toronto)

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Central Study Contacts

Howard Berger, MD

CONTACT

416 864 6060; Howard.Berger@unityhealth.to

Klaudia Szczech

CONTACT

416 867 7460; klaudia.szczech@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: October 27, 2022
• Study Start: August 23, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

CA (1)