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Trial registered on ANZCTR


Registration number
ACTRN12609000420246
Ethics application status
Approved
Date submitted
10/05/2009
Date registered
9/06/2009
Date last updated
30/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outpatient Foley catheter Vs inpatient Prostin gel for induction of labour
Scientific title
An evaluation of Outpatient Foley (intracervical) catheter versus Inpatient Prostaglandin Vaginal Gel (PGE2) on the induction of labour at term.
Secondary ID [1] 280049 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 4484 0
Condition category
Condition code
Reproductive Health and Childbirth 4763 4763 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foley catheter placed intracervically (with 30mL inflation of balloon) in women requiring cervical ripening procedure as part of induction of labour. Catheter placement procedure takes approximately 5 minutes. Women then return home while cervical ripening occurs (expected duration of catheter in situ 12-18 hours, maximum 24 hours) and return to hospital for induction the following day.
Intervention code [1] 4234 0
Treatment: Devices
Intervention code [2] 236725 0
Treatment: Other
Comparator / control treatment
Prostaglandin vaginal gel (PGE2: Prostin) as an inpatient for cervical ripening as part of induction of labour. Doses 2mg at baseline then 1mg at 6 hours following commencement of treatment for nulliparous women, 1mg at baseline then 1mg at 6 hours following commencement of treatment for multiparous women.
Control group
Active

Outcomes
Primary outcome [1] 5627 0
Percentage of women delivering vaginally within 12 hours of admission to Delivery Unit.
Timepoint [1] 5627 0
Measured at 12 hours after admission to Delivery Unit
Primary outcome [2] 5919 0
Total inpatient hours from induction to delivery
Timepoint [2] 5919 0
Measured prospectively by study researchers and correlated with medical record.
Secondary outcome [1] 241984 0
Percentage of women requiring syntocinon for induction or augmentation of labour, as assessed by actual syntocinon use during labour recorded in patient records.
Timepoint [1] 241984 0
Measured post-delivery
Secondary outcome [2] 241985 0
Mode of delivery (rate of Caesarean delivery, spontaneous vaginal delivery, and instrumental vaginal delivery)
Timepoint [2] 241985 0
At delivery
Secondary outcome [3] 241986 0
Induction to delivery interval i.e. time from commencement of cervical ripening to delivery
Timepoint [3] 241986 0
At delivery
Secondary outcome [4] 241987 0
Vaginal delivery within 24 hours of insertion of Foley Catheter or first dose PGE2 gel
Timepoint [4] 241987 0
At 24 hours post insertion of catheter or gel
Secondary outcome [5] 241988 0
Delivery within 24 hours of insertion of Foley Catheter or first dose PGE2 gel
Timepoint [5] 241988 0
At 24 hours post insertion of catheter or gel
Secondary outcome [6] 241989 0
Requirement for second method of cervical ripening or (in Prostin group) 3rd dose of prostaglandin, as assessed by actual use of 3rd dose Prostin in Prostin group, or crossover to use of Prostin from Foley group, recorded in patient file.
Timepoint [6] 241989 0
Checked post-delivery
Secondary outcome [7] 241990 0
Patient satisfaction using questionnaire created for purposes of this study.
Timepoint [7] 241990 0
Questionnaire 24-48 hours post-delivery
Secondary outcome [8] 241991 0
Return to hospital (Foleys group) prior to planned readmission and not in labour
Timepoint [8] 241991 0
Unscheduled return to hospital
Secondary outcome [9] 241992 0
Maternal febrile morbidity (temperature greater or equal to 38 degrees C on at least two occasions or greater than or equal to 38.5 degrees C on at least 1 occasion, measured using infrared thermometer to take tympanic temperature readings).
Timepoint [9] 241992 0
From commencement of induction to 48 hours post-delivery. Temperature is measured at intervals as per hospital protocol (2nd hourly while in labour and immediately post-delivery in Delivery Suite/Birth Centre, then daily thereafter unless clinical symptoms/signs infection).
Secondary outcome [10] 241993 0
Non-reassuring fetal heart rate trace as assessed by cardiotocograph monitoring.
Timepoint [10] 241993 0
From induction commencement to delivery. Cardiotocograph monitoring will occur in Foley group for 30 minutes (or until reassuring CTG obtained, whichever is longer) after initial insertion of Foley catheter, and in Prostin group for 30 minutes (or until reassurring CTG obtained, whichever is longer) after insertion of each dose of Prostin. Fetal heart rate is continuously monitored when induced women are in active labour in Delivery Suite.
Secondary outcome [11] 241994 0
Caesarean or instrumental delivery for fetal distress
Timepoint [11] 241994 0
delivery
Secondary outcome [12] 241995 0
Admission to newborn care as recorded in patient records.
Timepoint [12] 241995 0
Birth to 6 weeks of age
Secondary outcome [13] 241996 0
Apgar scores 1 and 5 minutes
Timepoint [13] 241996 0
At 1 and 5 minutes of life
Secondary outcome [14] 241997 0
Resource utilization as assessed by use of resource utilization form, which has been developed for the study in order to extract data on resource utilization from patient records.
Timepoint [14] 241997 0
From commencement of induction to 6 weeks post-partum
Secondary outcome [15] 241998 0
Epidural use as specified in patient records.
Timepoint [15] 241998 0
From induction to delivery

Eligibility
Key inclusion criteria
Age 18 and over
Gestational age 37 weeks or greater
Booked for cervical ripening procedure as part of induction of labour
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not suitable for outpatient management on maternal or fetal grounds
Potentially unsuitable for randomisation to prostaglandin gel use (e.g. uterine scar, oligohydramnios, grand multiparity)

Bishop's score 7 or more, or cervical dilation 2cm or greater, at time of booked induction

Regular painful uterine contractions at time of booked induction

Ruptured membranes

Chorioamnionitis or suspected chorioamnionitis

Multiple pregnancy

Non-vertex presentation

Non-English speaking

Allergy/hypersensitivity to Latex or PGE2 gel

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)
* Information leaflets about the trial to be made available to women in the late stages of pregnancy who may require induction of labour (IOL).
* All eligible women to be seen, enrolled and randomised on day of planned induction.
* All women for induction to have cardiotocograph (CTG), baseline vaginal examination (VE), and recording of Bishops score at time of admission for IOL, then eligible women to be randomised.

* Sequentially numbered, opaque, sealed envelopes will be used to contain the allocation assignment.

* Allocation assignments will be placed in envelope and envelope sealed by a person not otherwise involved in the conduct of the trial. * Envelopes are to be kept in a locked, secure area. * Envelopes will be opened only after participant details are written on the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5315 0
Royal Hospital for Women - Randwick

Funding & Sponsors
Funding source category [1] 4928 0
Hospital
Name [1] 4928 0
Department of Maternal Fetal Medicine
Royal Hospital for Women
Country [1] 4928 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Barker St
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 4457 0
None
Name [1] 4457 0
Address [1] 4457 0
Country [1] 4457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7002 0
South Eastern Sydney Illawarra Human Research Ethics Committee (HREC), Northern Network
Ethics committee address [1] 7002 0
Edmund Blackett Building
Cnr Avoca and High Streets
RANDWICK NSW 2031
Ethics committee country [1] 7002 0
Australia
Date submitted for ethics approval [1] 7002 0
Approval date [1] 7002 0
24/04/2009
Ethics approval number [1] 7002 0
1/09/0007

Summary
Brief summary
Aims of study are
1) To compare:
a) Clinical effectiveness
b) Patient acceptability
c) Safety

of the use of Foley catheter in the outpatient setting with intravaginal PGE2 (Prostin) gel in the inpatient setting for induction of labour.

2) To assess the cost-effectiveness of intracervical Foley catheter in the outpatient setting to intravaginal PGE2 (Prostin) gel in the inpatient setting for use in induction of labour.

The hypothesis is that for induction of labour in women with an unfavourable cervix, use of the catheter on an outpatient basis (women have catheter inserted, then go home until the following morning) will be at least as clinically effective and safe as use of gel as an inpatient (staying in hospital), and that outpatient catheter use will be both acceptable to women and cost-effective.

Currently, most pregnant women who need cervical ripening as part of an induction of labour stay in hospital from the time the gel or catheter is inserted until the cervix is ready for the rest of the induction. This means many women stay 12-24 hours in hospital while they are not in labour, but are waiting for the gel or catheter to work. Most women and their babies needing cervical ripening are otherwise very well, and could stay at home during this time if a safe and effective way to do this was available.
Trial website
Trial related presentations / publications
Peer-reviewed journal articles

1) Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh AW, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy and Childbirth 2013, 13:25

2) Madan A, Tracy S, Reid R, Henry A. Recruitment difficulties in obstetric trials: case study and review. ANZJOG 2014; 54 (6): 546-552.

3) Austin K, Chambers GM, de Abreu Lourenco R, Madan A, Susic D, Henry A. Cost-effectiveness of term induction of labour using inpatient prostaglandin gel versus outpatient Foley catheter. ANZJOG 2015; 55(4): 440-5. DOI: 10.1111/ajo.12348.
Public notes
Attachments [1] 774 774 0 0
/AnzctrAttachments/83727-Final article BMC Preg Childbirth.pdf

Contacts
Principal investigator
Name 29406 0
Dr Amanda Henry
Address 29406 0
School of Women's and Children's Health, University of New South Wales
Level 1, Royal Hospital for Women
Barker St (Locked Bag 2000)
Randwick, NSW 2031
Country 29406 0
Australia
Phone 29406 0
+61 2 91132315
Fax 29406 0
Email 29406 0
[email protected]
Contact person for public queries
Name 12653 0
Amanda Henry
Address 12653 0
School of Women's and Children's Health, University of New South Wales
Level 1, Royal Hospital for Women
Barker St (Locked Bag 2000)
Randwick, NSW 2031
Country 12653 0
Australia
Phone 12653 0
+61 91132315
Fax 12653 0
+61 2 93826444
Email 12653 0
[email protected]
Contact person for scientific queries
Name 3581 0
Amanda Henry
Address 3581 0
School of Women's and Children's Health, University of New South Wales
Level 1, Royal Hospital for Women
Barker St (Locked Bag 2000)
Randwick, NSW 2031
Country 3581 0
Australia
Phone 3581 0
+61 2 91132315
Fax 3581 0
+61 2 93826444
Email 3581 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCost-effectiveness of term induction of labour using inpatient prostaglandin gel versus outpatient Foley catheter.2015https://dx.doi.org/10.1111/ajo.12348
N.B. These documents automatically identified may not have been verified by the study sponsor.