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The Prediction modelling for Risk-Stratified care for women with Gestational Diabetes (PeRSonal GDM) study: Calculating the individualised risk of adverse outcomes for women with gestational diabetes.

The Prediction modelling for Risk-Stratified care for women with Gestational Diabetes (PeRSonal GDM) study: a model development and validation study for adverse outcomes in women with gestational diabetes.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000915954
Acronym
PeRSonal GDM
Enrollment
27446
Registered
2020-09-17
Start date
2019-11-18
Completion date
2019-12-31
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background Gestational diabetes (GDM) is a common yet highly heterogeneous condition. The ability to calculate the absolute risk of adverse pregnancy outcomes for an individual woman would allow preventative and therapeutic interventions to be delivered to women at high-risk, sparing women at low-risk from unnecessary care. Research Aims 1. To examine the outcomes of GDM in the context of current care. 2. To develop a prediction model for adverse pregnancy outcomes in women with GDM. Participants All pregnancies within the existing Monash Health maternity outcomes database with a birth recorded from 1 January 2016 to 31 December 2018. All analysis will be conducted using non-identifiable data. Methods Epidemiologic questions will be examined with logistic regression analysis. A multivariable prediction model will be developed using clinical characteristics routinely available at the time of GDM diagnosis. Recent methodologic advances aimed at developing clinical meaningful and implementable models will be utilised. Expected Outcomes Obesity, excess gestational weight gain and ethnicity are significant contributors to adverse pregnancy outcome in women with GDM in this real-world population-based dataset. A method for stratifying women with GDM by risk of adverse pregnancy outcomes will be developed.

Interventions

The condition observed is gestational diabetes. This observational study will use health data routinely collected for clinical care and to meet statutory perinatal data reporting requirements. Participants in this study will not be required to complete any additional questionnaires, interviews or tests. Observation will include the duration of the pregnancy and the immediate postpartum period until discharge from the hospital.

Sponsors

Monash Centre for Health Research and Implementation, Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

All pregnancies within the existing Monash Health maternity outcomes database with a birth recorded from 1 January 2016 to 31 December 2018.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026