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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 provided

29/07/2022

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]

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

placental insufficiency

intrauterine growth restriction

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Reproductive Health and Childbirth

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]

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]

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]

At recruitment, <34 weeks gestation, 34+0 to 36+6 weeks gestation, and 37+ weeks gestation.

Primary outcome [2]

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]

Birth

Secondary outcome [1]

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]

3 months after the birth date.

Secondary outcome [2]

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]

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?

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Roche Diagnostics International Ltd

Address [1]

Forrenstrasse 2
6343 Rotkreuz
Switzerland

Country [1]

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]

Individual

Name [1]

Ruth Hughes

Address [1]

Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
2 Riccarton Avenue
Christchurch 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

16/07/2018

Ethics approval number [1]

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

Dr Ruth Hughes

Address

Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644630

Fax

[email protected]

Contact person for public queries

Name

Ruth Hughes

Address

Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644630

Fax

[email protected]

Contact person for scientific queries

Name

Ruth Hughes

Address

Department of Obstetrics and Gynaecology
University of Otago
Christchurch Women's Hospital
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 3644630

Fax

[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.	Type	Email
8224	Informed consent form	[email protected]
8225	Study protocol	[email protected]
8226	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The predictive value of the sFlt-1/PlGF ratio in suspected preeclampsia in a New Zealand population: A prospective cohort study.	2023	https://dx.doi.org/10.1111/ajo.13549

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically