ANZCTR - Registration

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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]

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

Pregnancy loss

Reproductive health and childbirth

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

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]

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]

The study primary outcome is frequency of pregnancy loss in women with gestational diabetes as determined from medical records.

Timepoint [1]

The study primary timepoint is the timing of delivery

Secondary outcome [1]

Diagnosis of gestational diabetes in women with and without history of pregnancy loss, determined from medical records.

Timepoint [1]

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?

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]

The Sutherland Hospital - Caringbah

Recruitment postcode(s) [1]

2229 - Caringbah

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sutherland Hospital, NSW

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sutherland Hospital

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Dana Bliuc, UNSW, Sydney

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Aboriginal Health & Medical Research Council Ethics Committee

Ethics committee address [1]

https://www.ahmrc.org.au/ethics-at-ahmrc/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2023

Approval date [1]

12/10/2023

Ethics approval number [1]

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

Dr Malgorzata Brzozowska

Address

Sutherland Hospital, Kareena Rd, Caringbah NSW 2229

Country

Australia

Phone

+61 2 9540 7111

Fax

malgorzata.brzozowska@health.nsw.gov.au

Contact person for public queries

Name

Malgorzata Brzozowska

Address

Sutherland Hospital, Kareena Rd, Caringbah NSW 2229

Country

Australia

Phone

+61 2 9540 7111

Fax

malgorzata.brzozowska@health.nsw.gov.au

Contact person for scientific queries

Name

Malgorzata Brzozowska

Address

Sutherland Hospital, Kareena Rd, Caringbah NSW 2229

Country

Australia

Phone

+61 2 9540 7111

Fax

malgorzata.brzozowska@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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