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Trial registered on ANZCTR


Registration number
ACTRN12617001639314
Ethics application status
Approved
Date submitted
17/11/2017
Date registered
18/12/2017
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of sulindac to delay premature birth in pregnancies complicated by a short cervix
Scientific title
A randomised controlled trial of sulindac to delay premature birth in pregnancies complicated by a short cervix
Secondary ID [1] 293390 0
None
Universal Trial Number (UTN)
Trial acronym
SULiP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Short cervix 305527 0
Premature birth 305652 0
pregnancy 305653 0
Condition category
Condition code
Reproductive Health and Childbirth 304873 304873 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to determine whether a medicine given during pregnancy can help to delay or prevent premature birth. This may reduce health complications in the newborn baby that can occur by being born too early.
Sulindac (Aclin®) is a medicine belonging to a group of medicines called non-steroidal anti-inflammatories (NSAIDS).
Sulindac 100mg will be given orally twice daily for 14 days to prolong gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.
Intervention code [1] 299640 0
Treatment: Drugs
Comparator / control treatment
Placebo will be given orally twice daily for 14 days to prolong gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.
The placebo will be used as a control. The placebo tablet contains Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate, and Sodium stearyl fumarate.
Control group
Placebo

Outcomes
Primary outcome [1] 303993 0
Primary Outcome:
To assess whether sulindac therapy prolongs gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy by at least 9 days.
This will be assessed by a review of medical records for date of delivery.
Timepoint [1] 303993 0
The outcome will be assessed at birth.
Secondary outcome [1] 340670 0
The comparison of neonatal outcomes of babies born to mothers who received antenatal sulindac therapy with those of babies whose mothers received placebo. This outcome will be determined through a review of neonatal medical records.
Timepoint [1] 340670 0
Neonatal outcomes will be assessed from the time of birth until hospital discharge.
Secondary outcome [2] 340671 0
To quantify the impact of sulindac therapy on cervical length measurements, as assessed by serial sonographic assessments.
Timepoint [2] 340671 0
At enrolment, day 4, 7 and 14
Secondary outcome [3] 340672 0
To generate exploratory data regarding the safety and tolerance of sulindac in pregnant women. This will be done by the recording of any expected or unexpected adverse effects experienced by the participant, regardless of whether the event appears related to the intervention.
Timepoint [3] 340672 0
Enrollment until treatment cessation
Secondary outcome [4] 340832 0
To quantify the impact of sulindac therapy on amniotic fluid volumes by conducting AFI (Amniotic Fluid Index) readings by ultrasound
Timepoint [4] 340832 0
This outcome will be measured at day 4, 7 and 14.

Eligibility
Key inclusion criteria
Age 18-45
-Gestation 18+0/40 - 23+6/40 weeks by EDD established according to RWH guidelines
-Consent to sonographic estimation of AFI (Amniotic Fluid Index) scores
-Cervical length 0-15mm on transvaginal ultrasonography, performed using a standardised technique14
-Singleton pregnancy
-Has received treatment with vaginal progesterone pessaries
-Has received treatment with cervical cerclage
-Has been submitting to recommended ‘bed rest’
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Gestation outside 18+0/40 - 23+6/40 week range
-Multiple pregnancy
-Cervical length greater than 15mm
-Known allergy to sulindac
-Pre-existing oligohydramnios / AFI <10 cm
-Pre-existing clinical chorioamnionitis
-Inability to provide informed consent
-History of any contraindications to NSAIDS, including: acute dehydration, NSAID-sensitive asthma, coagulation disorders, heart failure, active peptic ulcer disease or GI bleeding, renal impairment / CrCl<25mL/min.

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)
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298015 0
Hospital
Name [1] 298015 0
The Royal Women's Hospital
Address [1] 298015 0
The Royal Women's Hospital
Cnr Grattan St & Flemington Rd
Parkville
VIC 3052
Country [1] 298015 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
The Royal Women's Hospital
Cnr Grattan St & Flemington Rd
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 297090 0
None
Name [1] 297090 0
Address [1] 297090 0
Country [1] 297090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299051 0
Ethics committee address [1] 299051 0
Ethics committee country [1] 299051 0
Date submitted for ethics approval [1] 299051 0
Approval date [1] 299051 0
29/08/2017
Ethics approval number [1] 299051 0

Summary
Brief summary
This study aims to assess whether sulindac therapy (100mg TWICE daily orally for 14 days) prolongs gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79114 0
Dr Penny Sheehan
Address 79114 0
The Royal Womens Hospital
Cnr of Grattan St & Flemington Rd
Parkville
VIC 3052
Country 79114 0
Australia
Phone 79114 0
+61 3 83452000
Fax 79114 0
Email 79114 0
Penny.Sheehan@thewomens.org.au
Contact person for public queries
Name 79115 0
Dr Penny Sheehan
Address 79115 0
The Royal Womens Hospital
Cnr of Grattan St & Flemington Rd
Parkville
VIC 3052
Country 79115 0
Australia
Phone 79115 0
+61 3 83452000
Fax 79115 0
Email 79115 0
Penny.Sheehan@thewomens.org.au
Contact person for scientific queries
Name 79116 0
Dr Penny Sheehan
Address 79116 0
The Royal Womens Hospital
Cnr of Grattan St & Flemington Rd
Parkville
VIC 3052
Country 79116 0
Australia
Phone 79116 0
+61 3 83452000
Fax 79116 0
Email 79116 0
Penny.Sheehan@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient health data is confidential as per hospital and Australian policy and will be pooled as per study design. Individual patients have the right to access information collected from them and stored by researchers in accordance with relevant Australian privacy laws.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
Not applicable