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

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

Non Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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 details
    Gestational Diabetes Mellitus in Pregnancy

NCT05596812

Unity Health Toronto

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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