Recruiting

Gestational Diabetes

Sponsor:

Unity Health Toronto

Code:

NCT05596812

Conditions

Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

New Care Pathway

Study Details

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

Study ID

NCT05596812

Start date

Aug 23, 2022

Status verified date

Oct, 2022

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention (Risk Stratification Pathway)

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.

no intervention: Control (Routine Care)

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

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

Primary outcome measure

  • Feasibility of the novel risk stratification screening tool [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Howard Berger, MD

416 864 6060Howard.Berger@unityhealth.to

Klaudia Szczech

416 867 7460klaudia.szczech@unityhealth.to

Locations

St. Michael's Hospital (Unity Health Toronto)

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Howard Berger, MD

416 864 6060Howard.Berger@unityhealth.to

Klaudia Szczech

416 867 7460Klaudia.Szczech@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Oct 27, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2022-10-27.