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

NCT05596812 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-10-27

No results posted yet for this study

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

Interventions

OTHER

New Care Pathway

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

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2023-08-31
Completion
2024-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596812 on ClinicalTrials.gov