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Trial registered on ANZCTR


Registration number
ACTRN12624000956505
Ethics application status
Approved
Date submitted
22/06/2024
Date registered
7/08/2024
Date last updated
7/08/2024
Date data sharing statement initially provided
7/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does previous pregnancy loss increase the risk for gestational diabetes?
Scientific title
The effect of reproductive history on future risk of gestational diabetes.
Secondary ID [1] 312380 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Line by line individual data for 150 participants (participant's age, ethnicity, body mass index (BMI), presence of GDM, family history of diabetes, parity, number of previous miscarriages and pregnancy terminations, previous history of GDM) collected in year 2022 as part of the study: "To determine an association between metformin use in gestational diabetes mellitus and vitamin B12 deficiency" (trial id: ACTRN12620000397910) will also be included in this study" as part of existing database..

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 334173 0
Pregnancy loss 334174 0
Reproductive health and childbirth 334320 0
Condition category
Condition code
Metabolic and Endocrine 330840 330840 0 0
Diabetes
Reproductive Health and Childbirth 330977 330977 0 0
Antenatal care
Reproductive Health and Childbirth 330978 330978 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will conduct a retrospective case control study, which will compare the previous exposures to pregnancy loss in women with and without diagnosis of gestational diabetes (GDM). This project will use the antenatal database from the Sutherland hospital for gestational diabetes data which were collected between years 2016 -2018. The antenatal database holds information on study participant's age, ethnicity, body mass index (BMI), presence of gestational diabetes, family history of diabetes, parity, number of previous miscarriages and pregnancy terminations, previous history of GDM, history of thyroid disease and thyroid hormone levels, gestational age and neonatal birth weight. We will be aiming to analyse data on 500 GDM women and these data will be matched with data on 500 women of similar age and BMI and ethnicity however without GDM.
Line by line individual participant data for 150 participants (participant's age, ethnicity, body mass index (BMI), presence of gestational diabetes, family history of diabetes, parity, number of previous miscarriages and pregnancy terminations, previous history of GDM) collected in year 2022 as part of the study: "To determine an association between metformin use in gestational diabetes mellitus and vitamin B12 deficiency" (trial id: ACTRN12620000397910) will also be included in this study".
Intervention code [1] 328878 0
Not applicable
Comparator / control treatment
It is a retrospective case control study, The control group will consist of 500 women without presence of GDM. who will be matched with examined GDM cases for age, BMI and ethnicity.
Control group
Active

Outcomes
Primary outcome [1] 338611 0
The study primary outcome is frequency of pregnancy loss in women with gestational diabetes as determined from medical records.
Timepoint [1] 338611 0
The study primary timepoint is the timing of delivery
Secondary outcome [1] 436607 0
Diagnosis of gestational diabetes in women with and without history of pregnancy loss, determined from medical records.
Timepoint [1] 436607 0
The timepoint of gestational diabetes diagnosis.

Eligibility
Key inclusion criteria
1) The exposure group consists of pregnant women with gestational diabetes who attended the antenatal Endocrine clinic at Sutherland Hospital during their pregnancy between 2016 and 2018.
2) The control group consists of pregnant women without a diagnosis of gestational diabetes, matched by age, BMI, and ethnicity, who also attended the antenatal Endocrine clinic at Sutherland Hospital during their pregnancy between 2016 and 2018.
3) Data for 150 participants collected in year 2022 as part of the study: "To determine an association between metformin use in gestational diabetes mellitus and vitamin B12 deficiency" (trial id: ACTRN12620000397910) will also be included in this study".
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with Type 1 and 2 pre-gestational diabetes as well as women with BMI exceeding 35 kg/m2 will be excluded from the analysis, as their care was transferred to the tertiary referral centre.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
Retrospective case control study which will compare the previous exposures to miscarriage/termination of pregnancies in women with and without diagnosis of GDM. We will be aiming to analyse data on 500 GDM women and these data will be matched with data on 500 women of similar age and BMI and ethnicity however without GDM. The proposed study design will have power of 0.80 and of 0.05 to detect a difference of 70% in GDM incidence in women with and without history of pregnancy loss

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26721 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 42760 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 316788 0
Hospital
Name [1] 316788 0
Sutherland Hospital, NSW
Country [1] 316788 0
Australia
Primary sponsor type
Hospital
Name
Sutherland Hospital
Address
Country
Australia
Secondary sponsor category [1] 319009 0
Individual
Name [1] 319009 0
Dr Dana Bliuc, UNSW, Sydney
Address [1] 319009 0
Country [1] 319009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315557 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 315557 0
https://www.ahmrc.org.au/ethics-at-ahmrc/
Ethics committee country [1] 315557 0
Australia
Date submitted for ethics approval [1] 315557 0
15/08/2023
Approval date [1] 315557 0
12/10/2023
Ethics approval number [1] 315557 0

Summary
Brief summary
In Australia, gestational diabetes (GDM) affects around 10% of pregnancies with up to 30% of GDM pregnancies in a high-risk population. GDM carries a small but potentially important risk of adverse perinatal outcomes and a longer-term risk of metabolic abnormalities in mother and her offspring. Several factors such as patient’s age and family history and raised body mass index (BMI) are associated with future higher risk for GDM. Women who experienced repeated miscarriages were reported to have a higher prevalence of insulin resistance, which increases their risk for gestational diabetes. ;Although up to 20 % of pregnancies end up in an unintended termination of pregnancy there is a paucity of data examining impact of women reproductive history on their future risk of GDM. A recent metanalysis of 10 studies has revealed a 1.62-fold risk of gestational diabetes (95% CI: 1.32–1.98) compared to those never experiencing a miscarriage. In this metanalysis the majority
of collected data were ascertained from patients’ questionnaires without effect measure being adjusted for GDM predisposing risk factors. We are planning to conduct a case control study which will compare the previous exposures to miscarriage/termination of
pregnancies in women with and without diagnosis of GDM. We will be aiming to analyse data on 500 GDM women and these data will be matched with data on 500 women of similar age and BMI and ethnicity however without GDM. We have already collected
data on 150 women with GDM with the miscarriage prevalence of 33%. The proposed study design will have power of 0.80 and of 0.05 to detect a difference of 70% in GDM incidence in women with and without history of pregnancy loss. Considering the large number of miscarriages, evaluating the link between previous pregnancy loss and hyperglycaemia may allow for an additional monitoring and earlier intervention in women at high risk for GDM.
Trial website
Trial related presentations / publications
Public notes
The data on 150 participants were previously collected in year 2022 as part of the study: "To determine an association between metformin use in gestational diabetes mellitus and vitamin B12 deficiency." Trial Id: ACTRN12620000397910. We intend to use relevant data from the trial "To determine an association between metformin use in gestational diabetes mellitus and vitamin B12 deficiency" in the present study.

Contacts
Principal investigator
Name 37542 0
Dr Malgorzata Brzozowska
Address 37542 0
Sutherland Hospital, Kareena Rd, Caringbah NSW 2229
Country 37542 0
Australia
Phone 37542 0
+61 2 9540 7111
Fax 37542 0
Email 37542 0
[email protected]
Contact person for public queries
Name 37543 0
Malgorzata Brzozowska
Address 37543 0
Sutherland Hospital, Kareena Rd, Caringbah NSW 2229
Country 37543 0
Australia
Phone 37543 0
+61 2 9540 7111
Fax 37543 0
Email 37543 0
[email protected]
Contact person for scientific queries
Name 37544 0
Malgorzata Brzozowska
Address 37544 0
Sutherland Hospital, Kareena Rd, Caringbah NSW 2229
Country 37544 0
Australia
Phone 37544 0
+61 2 9540 7111
Fax 37544 0
Email 37544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.