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Trial registered on ANZCTR


Registration number
ACTRN12622001159741
Ethics application status
Approved
Date submitted
28/07/2022
Date registered
24/08/2022
Date last updated
24/08/2022
Date data sharing statement initially provided
24/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the use of pregnancy biomarkers (blood test) in women with pre-existing diabetes, to identify women at risk of placental insufficiency in order to optimise their antenatal care
Scientific title
Evaluation of SFlt/PLGF ratio in women with pre-existing diabetes to identify those at risk of placental insufficiency in order to optimise their antenatal care
Secondary ID [1] 307671 0
None
Universal Trial Number (UTN)
Trial acronym
DIPPS
Diabetes in Pregnancy: Routine Screening for Placental Insufficiency using the sFlt-1/PlGF ratio
Linked study record

Health condition
Health condition(s) or problem(s) studied:
placental insufficiency 327200 0
pre-eclampsia 327201 0
fetal growth restriction 327202 0
Type 1 diabetes 327424 0
Type 2 diabetes 327425 0
Condition category
Condition code
Reproductive Health and Childbirth 324340 324340 0 0
Antenatal care
Reproductive Health and Childbirth 324341 324341 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 324550 324550 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Blood sampling for the SFlt/PLGF ratio at 4 weekly intervals from recruitment at 20-24 weeks gestation until 36 weeks gestation.
A 4ml study blood sample will be drawn by a practicing phlebotomist at the time the mother is recruited and subsequently at outpatient visits. Blood will be drawn when the mother attends her scheduled appointments at Christchurch Women's hospital at four weekly intervals until 36 weeks gestation.
No extra visits will be required for study purposes.
Strategies used to monitor adherence to the intervention: checklists for the timing of blood samples will be placed in the front of the paper records for each participant and electronic reminders will be attached to outpatient schedules.
Intervention code [1] 324140 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332141 0
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 36 weeks gestation. This will be assessed by blood sample.
Timepoint [1] 332141 0
36 weeks gestation. The outcome will be assessed retrospectively after the birth.
Secondary outcome [1] 413241 0
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 20 weeks gestation. This will be assessed by blood sample.
Timepoint [1] 413241 0
20 weeks gestation. The outcome will be assessed retrospectively after the birth.
Secondary outcome [2] 413242 0
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 24 weeks gestation. This will be assessed by blood sample.
Timepoint [2] 413242 0
24 weeks gestation
Secondary outcome [3] 413243 0
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 28 weeks gestation. This will be assessed by blood sample.
Timepoint [3] 413243 0
28 weeks gestation
Secondary outcome [4] 413244 0
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 32 weeks gestation. This will be assessed by blood sample.
Timepoint [4] 413244 0
32 weeks gestation

Eligibility
Key inclusion criteria
• Age 18 and over
• Ability to provide informed consent
• Live pregnancy at admission to trial
• No current suspicion of placental insufficiency
• 20+0 to 24+6 weeks gestation
• Type 1 or type 2 diabetes
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Placental insufficiency is already suspected and under investigation prior to recruitment.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 24923 0
New Zealand
State/province [1] 24923 0
Canterbury and Otago

Funding & Sponsors
Funding source category [1] 311938 0
Charities/Societies/Foundations
Name [1] 311938 0
NZSSD: New Zealand Society for the Study of Diabetes
Country [1] 311938 0
New Zealand
Funding source category [2] 311941 0
Commercial sector/Industry
Name [2] 311941 0
Roche Diagnostics International Ltd
Country [2] 311941 0
Switzerland
Primary sponsor type
Individual
Name
Ruth Hughes
Address
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
2 Riccarton Avenue
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 313421 0
None
Name [1] 313421 0
N/A
Address [1] 313421 0
N/A
Country [1] 313421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311371 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 311371 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 311371 0
New Zealand
Date submitted for ethics approval [1] 311371 0
Approval date [1] 311371 0
14/07/2022
Ethics approval number [1] 311371 0
2022 FULL 12931

Summary
Brief summary
This is a small study to look at the potential benefits of introducing a blood test (SFlt/PlGF ratio) to screen for placental insufficiency in pregnant women with preexisting (type 1 or type 2) diabetes. Placental insufficiency (a placenta that is not working well) may lead to preeclampsia (high blood pressure) and / or fetal growth restriction (small baby) and affects one in ten pregnancies in New Zealand, but women with pre-existing diabetes have 2-4 times the risk. Placental insufficiency can be hard to detect and when doctors think that there may be a placental problem, women have extra hospital visits and tests to determine when it is safest for the baby to be born.
The study blood test is called the SFlt/PlGF ratio and it measures two proteins that affect blood vessels in the placenta and in the mother's circulation. Previous studies have found that this test may help doctors to decide whether pregnant mothers with symptoms have placental insufficiency and guide their care. The blood test may be able to separate women who need to give birth early from those who don’t.. In this study we will be assessing the value of screening for placental insufficiency before there are symptoms or signs of disease, to identify mothers at greatest risk who may then require extra monitoring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120866 0
Dr Ruth Hughes
Address 120866 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 120866 0
New Zealand
Phone 120866 0
+64 3 3644031
Fax 120866 0
Email 120866 0
ruth.hughes@cdhb.health.nz
Contact person for public queries
Name 120867 0
Dr Ruth Hughes
Address 120867 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 120867 0
New Zealand
Phone 120867 0
+64 3 3644031
Fax 120867 0
Email 120867 0
ruth.hughes@cdhb.health.nz
Contact person for scientific queries
Name 120868 0
Dr Ruth Hughes
Address 120868 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 120868 0
New Zealand
Phone 120868 0
+64 3 3644031
Fax 120868 0
Email 120868 0
ruth.hughes@cdhb.health.nz

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.