Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001186943
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
9/11/2020
Date last updated
29/07/2022
Date data sharing statement initially provided
9/11/2020
Date results information initially provided
27/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the use of pregnancy biomarkers (blood test), to identify women at risk of placental insufficiency in order to optimise their antenatal care.
Scientific title
Evaluation of SFlt/PLGF ratio to identify women at risk of placental insufficiency in order to optimise their antenatal care
Secondary ID [1] 294505 0
Nil known
Universal Trial Number (UTN)
U1111-1211-8323
Trial acronym
PIPIT: Preventing unnecessary intervention in placental insufficiency trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre eclampsia 317842 0
placental insufficiency 317843 0
intrauterine growth restriction 317844 0
Condition category
Condition code
Reproductive Health and Childbirth 315897 315897 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 317346 317346 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Blood sampling for the SFlt/PLGF ratio at 1-4 weekly intervals from recruitment until birth.

A 4ml study blood sample will be drawn by a practicing phlebotomist or midwife at the time the mother is recruited and subsequently when other routine antenatal bloods are drawn during pregnancy until the day of birth, but no more frequently than once per week.

The blood samples will be drawn when the mother is assessed at Christchurch Women's hospital, either in an outpatient or inpatient setting. No extra visits will be required for study purposes.

The frequency of the study blood tests will be determined by the frequency of the mother's routine assessments and antenatal blood tests taken at Christchurch Women's Hospital.

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] 317814 0
Diagnosis / Prognosis
Comparator / control treatment
Yes - women who agree to the intervention but who are not suspected of having placental insufficiency. A blood sample will be drawn at recruitment and subsequently when routine antenatal blood tests are carried out from recruitment until birth.
Eligibility criteria for the comparator cohort:
• Age 18 and over
• Ability to perform informed consent
• Singleton live pregnancies at admission to trial
• 20+0 to 36+6 weeks gestation
Control group
Active

Outcomes
Primary outcome [1] 324110 0
Median sFlt-1/PlGF ratio in New Zealand women with and without placental insufficiency by ethnicity. This will be assessed by blood sample.
Timepoint [1] 324110 0
At recruitment, <34 weeks gestation, 34+0 to 36+6 weeks gestation, and 37+ weeks gestation.
Primary outcome [2] 330263 0
The predictive value of a sFlt-1/PlGF ratio cut-point of 38, in women less than 35+0 weeks gestation, to predict birth within 14 days. The sFlt-1/PlGF ratio is determined by blood test..
Timepoint [2] 330263 0
Birth
Secondary outcome [1] 383784 0
Economic analysis: would knowing the test result have reduced cost.

Outcome measured by the calculating the difference between resource used, collected from hospital medical records,
Timepoint [1] 383784 0
3 months after the birth date.
Secondary outcome [2] 405505 0
The predictive value of a sFlt-1/PlGF ratio cut-off of 38, in women less than 37+0 weeks gestation, to rule out preeclampsia within 1 week and to rule in preeclampsia within 4 weeks of the baseline visit, The sFlt-1/PlGF ratio is determined by blood test..
Timepoint [2] 405505 0
At 1 and 4 weeks after the baseline visit

Eligibility
Key inclusion criteria
Age 18 and over.
Ability to perform informed consent.
Singleton live intra-uterine pregnancy at admission to trial.
20+0 to 36+6 weeks gestation.
Clinical suspicion of placental insufficiency (preeclampsia and / or fetal growth restriction).
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known fetal chromosomal abnormality.
Known major fetal congenital abnormality.
Multiple pregnancy.


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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/12/2018
Date of last participant enrolment
Anticipated
4/12/2020
Actual
14/12/2020
Date of last data collection
Anticipated
7/05/2021
Actual
4/10/2021
Sample size
Target
220
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 22671 0
New Zealand
State/province [1] 22671 0
Canterbury

Funding & Sponsors
Funding source category [1] 299131 0
Commercial sector/Industry
Name [1] 299131 0
Roche Diagnostics International Ltd
Country [1] 299131 0
Switzerland
Primary sponsor type
University
Name
University of Otago
Address
Department of Obstetrics and Gynaecology
University of Otago
Christchurch
Christchurch Women's Hospital
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 298389 0
Individual
Name [1] 298389 0
Ruth Hughes
Address [1] 298389 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
2 Riccarton Avenue
Christchurch 8140
Country [1] 298389 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300063 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300063 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
Wellington
6011
Ethics committee country [1] 300063 0
New Zealand
Date submitted for ethics approval [1] 300063 0
Approval date [1] 300063 0
16/07/2018
Ethics approval number [1] 300063 0

Summary
Brief summary
This is a small study to look at the potential benefits of introducing a blood test (SFlt/PlGF ratio) to guide the care of New Zealand women with suspected placental problems. 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. When doctors think that there may be a placental problem, women have extra hospital visits and tests. Placental insufficiency can be hard to detect and it can be difficult to work out 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. Studies in other countries have found that this test may help doctors to decide whether pregnant mothers 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.
This study will look at the use of the SFlt/PlGF ratio blood test in New Zealand as we need to make sure this test works as well in our people/Tangata whenua. We want to find out if the blood test can help pregnant mothers at
low risk of needing to birth early, by reducing the number of hospital visits, ultrasound scans and blood tests in women who do not need them. We also want to see if this blood test can help us detect the pregnant mothers at
high risk of an early birth who need to be in hospital for monitoring.
In the future the test may be introduced as standard care in New Zealand as it is in some other countries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82438 0
Dr Ruth Hughes
Address 82438 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 82438 0
New Zealand
Phone 82438 0
+64 3 3644630
Fax 82438 0
Email 82438 0
[email protected]
Contact person for public queries
Name 82439 0
Dr Ruth Hughes
Address 82439 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 82439 0
New Zealand
Phone 82439 0
+64 3 3644630
Fax 82439 0
Email 82439 0
[email protected]
Contact person for scientific queries
Name 82440 0
Dr Ruth Hughes
Address 82440 0
Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140
Country 82440 0
New Zealand
Phone 82440 0
+64 3 3644630
Fax 82440 0
Email 82440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator
email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8224Informed consent form  [email protected]
8225Study protocol  [email protected]
8226Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hughes RCE, Phillips I, Florkowski CM, Gullam J. T... [More Details] 374845-(Uploaded-28-07-2022-09-36-17)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe predictive value of the sFlt-1/PlGF ratio in suspected preeclampsia in a New Zealand population: A prospective cohort study.2023https://dx.doi.org/10.1111/ajo.13549
N.B. These documents automatically identified may not have been verified by the study sponsor.