ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000584831

Ethics application status

Approved

Date submitted

28/05/2012

Date registered

30/05/2012

Date last updated

19/03/2021

Date data sharing statement initially provided

11/02/2019

Date results provided

11/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

STRIDER (NZAus): A randomised placebo-controlled trial of a new therapy (sildenafil) to help growth in severely growth restricted fetuses at very early gestations.

Scientific title

STRIDER (NZAus): A randomised placebo controlled trial of sildenafil therapy to improve fetal growth velocity in dismal prognosis early-onset intrauterine growth restriction (New Zealand and Australia).

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1131-2408

Trial acronym

STRIDER (NZAus)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Severe early onset fetal growth restriction

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Sildenafil 25mg three times a day as an oral tablet from randomisation until delivery (or 32 weeks gestation, whichever occurs first).

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo. Identical in appearance to sildenafil (film-coated, rounded-diamond-shaped tablets).

Control group

Placebo

Outcomes

Primary outcome [1]

The proportion of pregnancies with increased abdominal circumference (AC) growth velocity post treatment compared to pretreatment.

Timepoint [1]

Post-treatment growth velocity will be calculated 14 days after treatment commenced (if delivered prior then at 10, 5 or 2 days post-treatment).

Secondary outcome [1]

Mean absolute change in abdominal circumference (mm) per day

Timepoint [1]

14 days after treatment commenced (if delivered prior then at 10, 5 or 2 days post-treatment).

Secondary outcome [2]

Mean birthweight and mean birthweight centile

Timepoint [2]

At time of delivery

Secondary outcome [3]

Changes in uteroplacental, umbilical and fetal Doppler waveform studies.

Timepoint [3]

2, 5, 10 and 14 days after treatment commenced.

Secondary outcome [4]

Randomisation-to-delivery interval

Timepoint [4]

At time of delivery

Secondary outcome [5]

Measures of neonatal outcome; live-births, survival to hospital discharge, major morbidity including chronic lung disease requiring ambulatory oxygen therapy on hospital discharge, intraventricular haemorrhage grade 3-4, >grade 2 retinopathy of prematurity, necrotising enterocolitis, number of doses of surfactant, ventilator days, supplemental oxygen days and number of days to full feeds

Timepoint [5]

to time of hospital discharge

Secondary outcome [6]

Primary outcome of the childhood follow up assessment (STRIDER NZAus Childhood Follow Up Study): Survival free of neurosensory impairment at 2.5 years’ corrected age, defined by absence of cerebral palsy, deafness, blindness, cognitive delay (Bayley-III composite score cognition or language >1 SD below test mean) and motor delay (Bayley-III composite motor score >1 SD below test mean).

Timepoint [6]

2.5 years' corrected age (+/- 6 months)

Eligibility

Key inclusion criteria

1. Singleton pregnancy.
2a. At 22+0 weeks to 27+6 weeks: AC measure less than or equal to 3 percentile for gestational age; OR
2b. At 28+0 weeks to 29+6 weeks ultrasound estimate of fetal weight (EFW) <700grams.

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

1. Known major fetal anomaly/syndrome/congenital infection deemed to be the likely cause of IUGR.
2. Known fetal aneuploidy.
3. Already made plan for termination of pregnancy.
4. Maternal disease (e.g. pre-eclampsia) where it is expected that delivery is necessary within 48 hours.
5. Any contraindication to sildenafil therapy.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will be by central randomisation by phone/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomised stratified for gestational age at recruitment (less than 24 weeks vs. greater than or equal to 24 weeks) and present or absent/reversed end diastolic flow in umbilical arteries.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2014

Actual

11/03/2014

Date of last participant enrolment

Anticipated

Actual

17/03/2017

Date of last data collection

Anticipated

31/12/2019

Actual

28/02/2020

Sample size

Target

122

Accrual to date

Final

122

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of NZ (HRC)

Address [1]

PO Box 5541, Wellesley Street, Auckland 1141, New Zealand

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Cure Kids

Address [2]

PO Box 90 907
Victoria Street West
Auckland 1142
New Zealand

Country [2]

New Zealand

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Auckland Medical Research Foundation

Address [3]

Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148

Country [3]

New Zealand

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Neurological Foundation NZ

Address [4]

66 Grafton Road, Grafton, Auckland?PO Box 110022, Auckland City Hospital, Auckland 1148

Country [4]

New Zealand

Funding source category [5]

Other Collaborative groups

Name [5]

Mercia Barnes Trust RANZCOG

Address [5]

PO Box 10611, The Terrace, WELLINGTON 6143

Country [5]

New Zealand

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Maurice & Phyllis Paykel Trust

Address [6]

PO Box 110008
Auckland Hospital
Auckland 1148

Country [6]

New Zealand

Funding source category [7]

University

Name [7]

University of Auckland FRDF

Address [7]

Private Bag 92019, Auckland 1142, New Zealand

Country [7]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Address

Park Road, Grafton, Auckland 1023

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Auckland City Hospital

Address [1]

Park Road
Grafton
Auckland 1023

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee, New Zealand

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
 PO Box 5013
Wellington 6140
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

28/05/2012

Approval date [1]

02/10/2012

Ethics approval number [1]

Summary

Brief summary

Intrauterine growth restriction (IUGR) describes conditions where fetuses are smaller than expected for their gestational age. This puts the fetus at risk of death, hypoxia and preterm birth. If IUGR occurs early in pregnancy (i.e before 28 weeks gestation) survival rates are only 70% and survival free of major handicap (intact survival) is much lower at 20%. Current management involves intensive fetal surveillance and delivery when there is evidence of serious compromise (to avoid death in utero) but this leads to the consequent risks of prematurity. There is no known treatment for IUGR.
This is a double blind randomised placebo controlled trial of Sildenafil, a nitric oxide donor drug, that has the potential to vasodilate uteroplacental vessels improving placental function. It may represent a novel therapy for IUGR. It has been used in pregnancy without adverse events and in a small case-control study it improved daily fetal growth velocity. Women with severe early onset IUGR will be invited to take part in the study at MFM units across NZ and Australia. This study will demonstrate if Sildenafil improves fetal growth, the results will be used in collaboration with other similar studies planned worldwide to demonstrate if Sildenafil improves rates of survival free of major handicap.
This trial incorporates the STRIDER NZAus Childhood Outcome Study: a follow up assessment of all surviving children at 2-3 years’ corrected age to determine whether any benefit (or harm) seen in the newborn as a consequence of antenatal sildenafil therapy is sustained, or develops, through childhood.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Katie Groom

Address

Department of Obstetrics and Gynaecology, Faculty of Medical and Health Science, University of Auckland, Private Bag 92019 Auckland 1142, New Zealand

Country

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

k.groom@auckland.ac.nz

Contact person for public queries

Name

Dr Katie Groom

Address

Department of Obstetrics and Gynaecology
Faculty of Medical and Health Science
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

k.groom@auckland.ac.nz

Contact person for scientific queries

Name

Dr Katie Groom

Address

Department of Obstetrics and Gynaecology
Faculty of Medical and Health Science
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 373 7599 ext 89823

Fax

k.groom@auckland.ac.nz

Data sharing statement

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

Yes

What data in particular will be shared?

De-identified individual participant data underlying published results will be made available to the IPD group and upon request to other researchers.
The STRIDER NZAus trial and the Childhood Outcome Study are part of an international STRIDER IPD Consortium which will include data from four national trials undertaken in NZAus, UK, Netherlands and Canada which will be used in individual patient data (IPD) meta-analyses. It is expected that this collaboration will have sufficient power to assess the effect of sildenafil on survival free of major morbidity to primary discharge from hospital and will also explore effects in early childhood (age 2-3 years).

When will data be available (start and end dates)?

Data will be available from completion of primary analysis for STRIDER NZAus and the STRIDER NZAus Childhood Outcome sub-study. No end date.

Available to whom?

The de-identified data that support the findings of this study will be made available to the IPD Consortium, and upon request to researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Access is subject to approval by the Trial Steering Committee and any ethics requirements.

Available for what types of analyses?

Any purpose approved by the Trial Steering Committee.

How or where can data be obtained?

By contacting the Principal Investigator via email: k.groom@auckland.ac.nz. Access subject to approvals by Trial Steering Committee.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11092	Study protocol	Groom, K., Baker, P., McCowan, L., Stone, P., & Lee, A. (2016, May 18). STRIDER (NZAus): A Randomised Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (New Zealand and Australia). Zenodo. http://doi.org/10.5281/zenodo.56150
11093	Statistical analysis plan	Groom, Katie, Mackay, Laura, & Lee, Arier. (2017, August 15). STRIDER (NZAus): A Randomised Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction (New Zealand and Australia) - Statistical Analysis Plan. Zenodo. http://doi.org/10.5281/zenodo.998139

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	STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction.	2019	https://dx.doi.org/10.1111/1471-0528.15658

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

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