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Trial registered on ANZCTR


Trial ID
ACTRN12615000795594
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
31/07/2015
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Foley Catheter Latex versus Silicone for Cervical Ripening Prior to Term Induction of Labour: a randomized controlled trial
Scientific title
Women 16 years and over, booked for cervical ripening with a Foley catheter for term induction of labour will be randomised to either 18F latex Foley catheter or 18F silicone Foley catheter, to compare the incidence of inadvertent membrane rupture and effectiveness of cervical ripening
Secondary ID [1] 285292 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 292960 0
Pregnant Women Requiring Induction of Labour 295490 0
Condition category
Condition code
Reproductive Health and Childbirth 293253 293253 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. 18F 30mL Latex Foley Catheter
- Used for cervical ripening in induction of labour
- Will be administered in Day Assessment Unit by trained O&G medical and midwifery staff
- Will be used from time of insertion until catheter falls out or is removed at time of artificial rupture of membranes for commencement of induction of labour
- Foleys catheter usage will be checked by staff inserting foleys & 1x other member of staff
Intervention code [1] 290191 0
Treatment: Devices
Comparator / control treatment
2. 18F 30mL Sillicone Foley Catheter
- Used for cervical ripening in induction of labour
- Will be administered in Day Assessment Unit by trained O&G medical and midwifery staff
- Will be used from time of insertion until catheter falls out or is removed at time of artificial rupture of membranes for commencement of induction of labour
- Foleys catheter usage will be checked by staff inserting foleys & 1x other member of staff
Control group
Active

Outcomes
Primary outcome [1] 293105 0
Inadvertent Membrane Rupture
- Assessed by O&G registrar/resident on call with speculum examination
OR
- Assessed by midwifery staff with liquor seen on pad
Timepoint [1] 293105 0
Post insertion of foleys to the time of inadvertent rupture of membranes
Secondary outcome [1] 310340 0
Foley Catheter Insertion Failure
- To be reviewed from documentation in hospital notes
Timepoint [1] 310340 0
At time of insertion
Secondary outcome [2] 315618 0
Maternal discomfort during insertion
- Survey designed specifically for this study completed by patient which will be reviewed with notes
Timepoint [2] 315618 0
Immediately following foleys insertion with survey
Secondary outcome [3] 315619 0
Inserter assessment of ease of insertion
- Documentation from survey designed for this study for inserter
Timepoint [3] 315619 0
Immediately following foleys insertion with survey
Secondary outcome [4] 315620 0
Duration of time before catheter falls out after insertion
- Documentation from patient's notes
Timepoint [4] 315620 0
Duration from time of foley catheter insertion to time that catheter falls out
Secondary outcome [5] 315621 0
Composite labour outcomes including
a. Mode of delivery
b. Duration of labour
- To be reviewed from documentation from patient's notes
Timepoint [5] 315621 0
From onset of labour to delivery
Secondary outcome [6] 315622 0
Composite maternal labour complications including
a. Maternal fever greater than 38 degrees in labour
b. Maternal antibiotic administration for suspected chorioamnionitis
c. Maternal blood loss at delivery
- Data to be collected from patient history
Timepoint [6] 315622 0
From onset of labour to 24hrs post partum
Secondary outcome [7] 315623 0
Composite neonatal outcomes including
a. Apgar scores
b. Umbilical artery cord lactate
c. Admission to neonatal nursery
Data from patient and baby notes
Timepoint [7] 315623 0
From time of delivery to 24hrs of life

Eligibility
Key inclusion criteria
All women 16 years and over booked for cervical ripening with a Foley catheter before term induction of labour will be asked to participate in the study. Those who decline participation will have a Foley catheter material of the obstetrician’s choosing.
Minimum age
16 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Latex allergy
2. Bishop score greater than 7
3. Ruptured membranes
4. Placenta closer than 2cm from internal os or undiagnosed vaginal bleeding
5. Abnormal pre-ripening CTG
6. Prior use of prostaglandin gel or Foley catheter for ripening in the current pregnancy
7. Active or purulent infection of the lower genital tract
8. Lethal congenital anomaly or fetal demise
9. Age less than 16 years
10. Unable to consent

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)
Patients will be given information about the study on the day they are booked for cervical ripening.   They will then have time to read the information at home and return with any queries regarding the study.   On the day of cervical 
ripening,   patients will be approached by a member of the research team and asked if they wish to participate.   If 
proceeding with the study, they will sign the consent form and be randomised to one of the two groups.   If they do 
not wish to participate in the research, they will proceed with the booked Foley insertion using the material, latex or 
silicone, of the midwife or medical officer's choosing.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Shuffled opaque envelopes, in two groups stratified for parity (no previous birth after 20 weeks and more than 1 previous birth after 20 weeks), will be provided. The patient will select an envelope at random from the appropriate parity group, to and so on until all are used. Then another batch of opaque envelopes will be prepared for the next stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
To achieve a statistical power of 80% (a 0.05) in detecting an increase in inadvertent membrane rupture from 0.5% with latex to 2% with silicone will required 870 women in each arm of the study

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
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

Funding & Sponsors
Funding source category [1] 289919 0
Hospital
Name [1] 289919 0
Westmead Department of Obstetrics and Gynaecology
Address [1] 289919 0
Cnr Hawkesbury and Darcy Road
Westmead, NSW, 2145
Country [1] 289919 0
Australia
Primary sponsor type
Hospital
Name
Westmead Department of Obstetrics and Gynaecology
Address
Cnr Hawkesbury and Darcy Road
Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 288609 0
None
Name [1] 288609 0
Address [1] 288609 0
Country [1] 288609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291638 0
Western Sydney Local Health District HREC (EC00152)
Ethics committee address [1] 291638 0
Westmead Research Office,
Room 1072,
Level 1 Education Block,
Westmead Hospital
Hawkesbury Road
Westmead 2145 NSW
Ethics committee country [1] 291638 0
Australia
Date submitted for ethics approval [1] 291638 0
16/07/2014
Approval date [1] 291638 0
07/04/2015
Ethics approval number [1] 291638 0
AU/2/1789111

Summary
Brief summary
Foley catheters have long been used to ripen (soften, shorten and dilate) the cervix prior to induction of labour.   Two 
catheter materials are widely available – latex and silicone.   There is currently no evidence to guide practitioners as 
to which is preferable for cervical ripening with respect to ease of insertion, efficacy in ripening and safety for baby 
and mother.
The primary aim of this study is to determine if there is a difference in outcomes between the two types of catheter 
used ­ latex and silicone.   The primary outcome is inadvertent rupture of membranes.   
Secondary outcomes include:
1. Maternal discomfort at insertion
2. Inserter assessment of ease of insertion
3. Duration of time before catheter falls out 
4. Labour outcomes including: Mode of delivery, Duration of labour
5. Maternal labour complications including: Maternal fever, Antiobiotic administration for suspected chorioamnionitis,
Maternal blood loss at delivery
6. Neonatal outcomes including: Apgar scores, Umbilical artery cord lactate, admission to neonatal nursery
7. Foley catheter insertion failure
The study is a prospective randomized clinical trial to be carried out at Westmead Hospital in the Day Assessment 
Unit and the Birth Unit (the usual sites of Foley catheter insertion). Apart from the randomization of catheter material 
(latex v silicone) all other care will be identical to women not participating in the study.All women 16 years and over 
booked for cervical ripening with a Foley catheter before term induction of labour will be asked to participate in the 
study.   
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51246 0
Dr Therese McGee
Address 51246 0
Department of Obstetrics and Gynaecology
Clinical Support Unit, Level 3 , G Block
Westmead Hospital
Cnr Hawkesbury and Darcy Road
Westmead, NSW, 2145
Country 51246 0
Australia
Phone 51246 0
+61298457954
Fax 51246 0
+61298458664
Email 51246 0
terry.mcgee@health.nsw.gov.au
Contact person for public queries
Name 51247 0
Dr Therese McGee
Address 51247 0
Department of Obstetrics and Gynaecology
Clinical Support Unit, Level 3 , G Block
Westmead Hospital
Cnr Hawkesbury and Darcy Road
Westmead, NSW, 2145
Country 51247 0
Australia
Phone 51247 0
+61298457954
Fax 51247 0
+61298458664
Email 51247 0
terry.mcgee@health.nsw.gov.au
Contact person for scientific queries
Name 51248 0
Dr Therese McGee
Address 51248 0
Department of Obstetrics and Gynaecology
Clinical Support Unit, Level 3, G Block
Westmead Hospital
Cnr Hawkesbury and Darcy Road
Westmead, NSW, 2145
Country 51248 0
Australia
Phone 51248 0
+61298457954
Fax 51248 0
+61298458664
Email 51248 0
terry.mcgee@health.nsw.gov.au