ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Induction of labour

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Devices

Intervention code [2]

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]

Percentage of women delivering vaginally within 12 hours of admission to Delivery Unit.

Timepoint [1]

Measured at 12 hours after admission to Delivery Unit

Primary outcome [2]

Total inpatient hours from induction to delivery

Timepoint [2]

Measured prospectively by study researchers and correlated with medical record.

Secondary outcome [1]

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]

Measured post-delivery

Secondary outcome [2]

Mode of delivery (rate of Caesarean delivery, spontaneous vaginal delivery, and instrumental vaginal delivery)

Timepoint [2]

At delivery

Secondary outcome [3]

Induction to delivery interval i.e. time from commencement of cervical ripening to delivery

Timepoint [3]

At delivery

Secondary outcome [4]

Vaginal delivery within 24 hours of insertion of Foley Catheter or first dose PGE2 gel

Timepoint [4]

At 24 hours post insertion of catheter or gel

Secondary outcome [5]

Delivery within 24 hours of insertion of Foley Catheter or first dose PGE2 gel

Timepoint [5]

At 24 hours post insertion of catheter or gel

Secondary outcome [6]

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]

Checked post-delivery

Secondary outcome [7]

Patient satisfaction using questionnaire created for purposes of this study.

Timepoint [7]

Questionnaire 24-48 hours post-delivery

Secondary outcome [8]

Return to hospital (Foleys group) prior to planned readmission and not in labour

Timepoint [8]

Unscheduled return to hospital

Secondary outcome [9]

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]

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]

Non-reassuring fetal heart rate trace as assessed by cardiotocograph monitoring.

Timepoint [10]

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]

Caesarean or instrumental delivery for fetal distress

Timepoint [11]

delivery

Secondary outcome [12]

Admission to newborn care as recorded in patient records.

Timepoint [12]

Birth to 6 weeks of age

Secondary outcome [13]

Apgar scores 1 and 5 minutes

Timepoint [13]

At 1 and 5 minutes of life

Secondary outcome [14]

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]

From commencement of induction to 6 weeks post-partum

Secondary outcome [15]

Epidural use as specified in patient records.

Timepoint [15]

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]

Royal Hospital for Women - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Maternal Fetal Medicine
Royal Hospital for Women

Address [1]

Royal Hospital for Women
Barker St
Randwick
NSW 2031

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Hospital for Women

Address

Barker St
Randwick
NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Illawarra Human Research Ethics Committee (HREC), Northern Network

Ethics committee address [1]

Edmund Blackett Building
Cnr Avoca and High Streets
RANDWICK NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/04/2009

Ethics approval number [1]

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]

/AnzctrAttachments/83727-Final article BMC Preg Childbirth.pdf

Contacts

Principal investigator

Name

Dr Amanda Henry

Address

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

Australia

Phone

+61 2 91132315

Fax

amanda.henry@unsw.edu.au

Contact person for public queries

Name

Amanda Henry

Address

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

Australia

Phone

+61 91132315

Fax

+61 2 93826444

amanda.henry@unsw.edu.au

Contact person for scientific queries

Name

Amanda Henry

Address

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

Australia

Phone

+61 2 91132315

Fax

+61 2 93826444

amanda.henry@unsw.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Cost-effectiveness of term induction of labour using inpatient prostaglandin gel versus outpatient Foley catheter.	2015	https://dx.doi.org/10.1111/ajo.12348

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically