Gestational Diabetes Mellitus in PregnancyNCT05596812
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
A study testing New Care Pathway in people with Gestational Diabetes Mellitus in Pregnancy, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- New Care Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2022to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital (Unity Health Toronto)
Toronto, Ontario, M5B 1W8
Howard Berger, MD, 416 864 6060 ext. 2395, Howard.Berger@unityhealth.to
Klaudia Szczech, 416 867 7460 ext. 49092, Klaudia.Szczech@unityhealth.to
About this study
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.
- Being tested
- New Care Pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Care PathwayOther
The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the novel risk stratification screening tool
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
Measured: 2 years
Secondary outcomes (11)
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.
Measured: 2 years
Glycemic control - blood glucose (units)
mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL
Measured: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Glycemic control - blood glucose (percent above target)
percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)
Measured: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Gestational weight gain
in kilograms (kg)
Measured: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Development of hypertensive disorders of pregnancy
documented as recorded from patient charts (Yes/No)
Measured: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Delivery outcomes - gestational age at delivery
measured in weeks
Measured: recorded at time of delivery
Delivery outcomes - mode of delivery
vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined
Measured: recorded at time of delivery
Neonatal outcomes - size for gestational age
measured in grams
Measured: recorded at time of delivery
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.
Measured: recorded at delivery (at 1 minute and 5 minutes of age)
Health service outcomes - health resource utilization
total number of care encounters (categorized by department - endocrine, obstetric)
Measured: 2 years
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.
Measured: 2 years; administered to each participant at 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start23 Aug 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596812
- Sponsor's protocol ID
- 22-065
- Status last verified
- Oct 2022
- First submitted
- 28 Jul 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05596812
- Acronym / sponsor ID
- 22-065
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Risk Stratification Pathway) | Experimental | Other: New Care PathwayThose 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Care PathwayThe New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care. | Other | Intervention (Risk Stratification Pathway) |
Primary outcome
Feasibility of the novel risk stratification screening tool
Time frame: 2 years
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
11 secondary outcomes
Performance of the GDM risk stratification tool
Time frame: 2 years
Glycemic control - blood glucose (units)
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Glycemic control - blood glucose (percent above target)
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Gestational weight gain
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Development of hypertensive disorders of pregnancy
Time frame: approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Delivery outcomes - gestational age at delivery
Time frame: recorded at time of delivery
Delivery outcomes - mode of delivery
Time frame: recorded at time of delivery
Neonatal outcomes - size for gestational age
Time frame: recorded at time of delivery
Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Time frame: recorded at delivery (at 1 minute and 5 minutes of age)
Health service outcomes - health resource utilization
Time frame: 2 years
Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)
Time frame: 2 years; administered to each participant at 6-weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Care Pathway in people with Gestational Diabetes Mellitus in Pregnancy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howard Berger, MD (416 864 6060 ext. 2395, Howard.Berger@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the novel risk stratification screening tool (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.