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Trial registered on ANZCTR


Registration number
ACTRN12621000231842
Ethics application status
Approved
Date submitted
30/10/2020
Date registered
4/03/2021
Date last updated
13/10/2024
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Intrapartum SildEnafil safely Avert the Risks of Contraction-induced Hypoxia?
Scientific title
Can intrapartum Sildenafil Citrate safely avert the risks of contraction-induced hypoxia in labour? iSEARCH – a pragmatic multicentre Phase III randomised controlled trial.
Secondary ID [1] 302602 0
CTC0303
Universal Trial Number (UTN)
Trial acronym
iSEARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraction-induced hypoxia in labour 319486 0
Condition category
Condition code
Reproductive Health and Childbirth 317452 317452 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sildenafil Citrate is the study intervention in this trial. Treatment will commence after transfer to the labour ward once in labour or for induction of labour. The dose of SC is 50mg orally or equivalent placebo every 8 hours to a maximum of three doses.
Adherence will be monitored by a study team member who will observe the administration of the study drug to the participant.
Intervention code [1] 318949 0
Prevention
Comparator / control treatment
Placebo is the control intervention. Treatment will commence after transfer to the labour ward once in labour or for induction of labour. The dose of SC is 50mg orally or equivalent placebo every 8 hours to a maximum of three doses.
Composition: Hard gelatin capsules with inert capsule filler consisting of only of maize starch and pregelatinised maize starch.
Control group
Placebo

Outcomes
Primary outcome [1] 325555 0
Composite Outcome of:
a) Intrapartum Stillbirth
b) 28 Day Neonatal Death
c) Apgar Score <4 at 5 minutes
d) Cord Artery pH <7.0
e) Neonatal Encephalopathy
f) Neonatal seizures
g) Neonatal respiratory support >4h
h) Neonatal unit (Special Care or Intensive Care) admission lasting >48
i) Persistent pulmonary hypertension of the newborn
j) Meconium aspiration

Primary outcome data will be collected through standard of care and study assessments documented in participant source notes (including medical records).
Timepoint [1] 325555 0
Primary Outcomes a), d), j): At delivery
Primary Outcomes b), e), f): At any time between delivery and 28 days post delivery
Primary Outcomes g), h), i): At any time between delivery and discharge from the Neonatal unit
Primary Outcome c): Between delivery and 5 mins post delivery

Composite outcomes will be assessed together at study completion.
Secondary outcome [1] 388382 0
Relative risk of each individual component of the composite primary outcome - Intrapartum stillbirth.
Timepoint [1] 388382 0
At delivery
Secondary outcome [2] 388383 0
Relative risk of each individual component of the composite primary outcome -28-day neonatal death,
Timepoint [2] 388383 0
Up to 28 days post-delivery
Secondary outcome [3] 388384 0
Relative risk of each individual component of the composite primary outcome - Apgar score <4 at 5 minutes
Timepoint [3] 388384 0
5 minutes post delivery
Secondary outcome [4] 388385 0
Relative risk of each individual component of the composite primary outcome - Cord artery pH <7.0
Timepoint [4] 388385 0
At delivery
Secondary outcome [5] 388386 0
Relative risk of each individual component of the composite primary outcome - Neonatal encephalopathy
Timepoint [5] 388386 0
At any time between delivery and 28 days post delivery
Secondary outcome [6] 388387 0
Relative risk of each individual component of the composite primary outcome - Neonatal seizures
Timepoint [6] 388387 0
At any time between delivery and 28 days post delivery
Secondary outcome [7] 388388 0
Relative risk of each individual component of the composite primary outcome - Neonatal respiratory support >4h
Timepoint [7] 388388 0
Between delivery and discharge from the neonatal unit
Secondary outcome [8] 388389 0
Relative risk of each individual component of the composite primary outcome - Neonatal unit (Special Care or Intensive Care) admission lasting >48h
Timepoint [8] 388389 0
Between delivery and discharge from the neonatal unit
Secondary outcome [9] 388390 0
Relative risk of each individual component of the composite primary outcome - Persistent pulmonary hypertension of the newborn
Timepoint [9] 388390 0
Between delivery and discharge from the neonatal unit
Secondary outcome [10] 388391 0
Relative risk of each individual component of the composite primary outcome - Meconium aspiration
Timepoint [10] 388391 0
At delivery

Eligibility
Key inclusion criteria
1. Women with singleton or dichorionic twin pregnancies planning in-hospital vaginal birth at term (>37 weeks gestation).
2. Age 18 years and older.
3. Willing and able to comply with all study requirements.
4. Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A woman should not be entered if the responsible clinician or the woman are, for any medical or non­medical reasons, reasonably certain that SC would be inappropriate for her in comparison with no treatment or some other treatment that could be offered in or outside the trial.

2. Triplets or higher order multiple births, which are generally delivered electively before term.

3. Contraindications to the investigational product SC

4. Participants who are taking any type of nitrate drug therapy or who utilize short-acting nitrate-containing medications during labour [such as sodium nitroprusside, bosentan, fosamprenavir and ritonavir combination, hepatic enzyme inhibitors CYP3A4 (including itraconazole, ketoconazole, ritonavir, cimetidine, erythromycin, saquinavir, darunavir), or hepatic enzyme substrates (CYP3A4), medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors like riociguat], due to the risk of potentially life-threatening hypotension.

5. Severe hepatic or renal impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/03/2021
Actual
6/09/2021
Date of last participant enrolment
Anticipated
30/06/2024
Actual
28/06/2024
Date of last data collection
Anticipated
29/07/2024
Actual
28/07/2024
Sample size
Target
3200
Accrual to date
Final
3254
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21519 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 22994 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 22995 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [4] 22996 0
Casey Hospital - Berwick
Recruitment hospital [5] 22997 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 22998 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 26058 0
Royal Hospital for Women - Randwick
Recruitment hospital [8] 26059 0
The Royal Women's Hospital - Parkville
Recruitment hospital [9] 26060 0
Sunshine Hospital - St Albans
Recruitment hospital [10] 26061 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 26062 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 26063 0
Ipswich Hospital - Ipswich
Recruitment hospital [13] 26064 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 36426 0
4101 - South Brisbane
Recruitment postcode(s) [2] 38306 0
3168 - Clayton
Recruitment postcode(s) [3] 38307 0
3175 - Dandenong
Recruitment postcode(s) [4] 38308 0
3806 - Berwick
Recruitment postcode(s) [5] 38309 0
2050 - Camperdown
Recruitment postcode(s) [6] 38310 0
4029 - Herston
Recruitment postcode(s) [7] 41912 0
2031 - Randwick
Recruitment postcode(s) [8] 41913 0
3052 - Parkville
Recruitment postcode(s) [9] 41914 0
3021 - St Albans
Recruitment postcode(s) [10] 41915 0
4575 - Birtinya
Recruitment postcode(s) [11] 41916 0
4215 - Southport
Recruitment postcode(s) [12] 41917 0
4305 - Ipswich
Recruitment postcode(s) [13] 41918 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 307030 0
Government body
Name [1] 307030 0
NHMRC
Country [1] 307030 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NHMRC Clinical Trials Centre
Locked Bag 77
CAMPERDOWN NSW 1450
Country
Australia
Secondary sponsor category [1] 307674 0
None
Name [1] 307674 0
Address [1] 307674 0
Country [1] 307674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307160 0
Hunter New England Local Health District Human Research Ethics Committee (HNELHD HREC)
Ethics committee address [1] 307160 0
Ethics committee country [1] 307160 0
Australia
Date submitted for ethics approval [1] 307160 0
30/10/2020
Approval date [1] 307160 0
14/12/2020
Ethics approval number [1] 307160 0
2020/ETH02791

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106242 0
Prof Sailesh Kumar
Address 106242 0
Mater Clinical School-University of Queensland
Mater Health Services
1st Floor Whitty Building
South Brisbane
Queensland 4101
Australia
Country 106242 0
Australia
Phone 106242 0
+61 7 3163 8844
Fax 106242 0
Email 106242 0
sailesh.kumar@mater.uq.edu.au
Contact person for public queries
Name 106243 0
Alpana Ghadge
Address 106243 0
NHMRC Clinical Trials Centre
Locked Bag 77
CAMPERDOWN NSW 1450
Country 106243 0
Australia
Phone 106243 0
+61 2 9562 5000
Fax 106243 0
Email 106243 0
isearch.study@sydney.edu.au
Contact person for scientific queries
Name 106244 0
Sailesh Kumar
Address 106244 0
Mater Clinical School-University of Queensland
Mater Health Services
1st Floor Whitty Building
South Brisbane
Queensland 4101
Australia
Country 106244 0
Australia
Phone 106244 0
+61 7 3163 8844
Fax 106244 0
Email 106244 0
sailesh.kumar@mater.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data supporting the publication results and participant data relating to primary outcomes.
When will data be available (start and end dates)?
Data are available 6 months after publication
Data are available for an indefinite time
Start date: Jan 2025 (approx)
End date: Unknown
Available to whom?
Data are potentially available to:
- Researchers from not-for-profit organisations
- Commercial organisations
- Other
Based in:
- Any location

Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

For further information, please contact iSEARCH.study@sydney.edu.au.
Available for what types of analyses?
Any type of analysis and will be assessed on a case-by-case basis.
How or where can data be obtained?
Please contact the iSEARCH study team, at iSEARCH.study@sydney.edu.au.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23750Study protocol  isearch.study@sydney.edu.au
23751Data dictionary  isearch.study@sydney.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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