Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000039684
Ethics application status
Approved
Date submitted
19/12/2013
Date registered
16/01/2014
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Date results information initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostaglandin Inpatient iNduction of labour Compared with BALLOon Outpatient iNduction of labour: a randomised controlled trial
Scientific title
Amongst women with singleton uncomplicated pregnancies greater than or equal to 37 weeks 0 days undergoing induction of labour (IOL) for post-term pregnancy or for ‘social’ or ‘elective’ reasons, does the use of a balloon-catheter to commence an IOL as an outpatient, compared with prostaglandin vaginal gel administration to commence an IOL as an inpatient, improve perinatal health outcomes, reduce length of stay and other healthcare costs, and is it preferred by women?
Secondary ID [1] 283810 0
Nil
Universal Trial Number (UTN)
U1111-1151-5383
Trial acronym
The PINC BALLOON Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 290788 0
Condition category
Condition code
Reproductive Health and Childbirth 291156 291156 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women randomised to the balloon arm are not admitted to hospital but seen as an ‘occasion of service’ in Birth Suite / Assessment Unit / Antenatal Clinic. A pre-balloon cardiotocograph (CTG) will be placed for a minimum of 30 minutes until assessed to be normal. A cervical ripening balloon (CRB) plus stylet (Cook Medical, Bloomington, US) will be placed by a midwife / doctor by inserting it through the internal cervical os as part of a digital vaginal examination. 80mls of saline will be instilled into the cervical and vaginal balloons, and the stylet removed. The insertion would typically take less than 60 seconds. A post-balloon CTG is not required, unless the woman was to experience uterine activity following placement of the balloon. Following a period of observation of 30 minutes, and assuming she was not experiencing contractions or needing pain relief beyond simple analgesia, the woman will be allowed home. Women will be provided with written information about when to call and how to call the hospital. In the absence of vaginal bleeding, fluid loss, contractions, expulsion of the balloon, and/or need for pain relief beyond simple analgesia (any of which would necessitate earlier review), the woman will be asked to return to Birth Suites the following morning at 05:30am. At that time, the woman will be assessed by an experienced midwife, credentialed to perform ARM. The midwife will perform a cervical assessment and document the Modified Bishop’s score. An ARM will then be attempted, and once the membranes are ruptured, an oxytocin infusion should be commenced as soon as possible.
Intervention code [1] 288496 0
Treatment: Devices
Intervention code [2] 288497 0
Treatment: Drugs
Comparator / control treatment
Women randomised to the prostaglandin (PGE2) arm will be admitted to hospital. A pre-PGE2 CTG will be placed for a minimum of 30 minutes until assessed to be normal. Dinoprostone (Prostin) gel will be administered intravaginally by the midwife/doctor (2mg for nulliparous women and 1 mg for multiparous women). A post-PGE2 CTG will be placed for a minimum of 30 minutes until assessed to be normal. Women administered PGE2 will remain as inpatients. In the absence of vaginal bleeding, fluid loss, onset of regular painful contractions and/or need for pain relief beyond simple analgesia (any of which would necessitate earlier review), staff will endeavour to review all women the following morning at 05:30 in Birth Suites. At that time, the woman will be assessed by an experienced midwife, credentialed to perform ARM. The midwife will perform a cervical assessment and document the Modified Bishop’s score. An ARM will then be attempted, and once the membranes are ruptured, an oxytocin infusion should be commenced as soon as possible.
Control group
Active

Outcomes
Primary outcome [1] 291143 0
The primary outcome measure is a composite measure of neonatal outcome comprising one or more of:
a) Admission to neonatal critical care nursery
b) Need for intubation and/or external cardiac compressions
c) Neonatal academia, as measured by the proportion of babies born with cord arterial pH <7.10
d) Hypoxic ischaemic encephalopathy
e) Neonatal seizure
f) Infection (as defined by neonatal antibiotic administration)
g) Persistent pulmonary hypertension of the newborn (PPHN)
Timepoint [1] 291143 0
At time of birth
Secondary outcome [1] 306117 0
Mode of birth
Timepoint [1] 306117 0
At time of birth
Secondary outcome [2] 306119 0
Time from randomisation to birth
Timepoint [2] 306119 0
At time of birth
Secondary outcome [3] 306120 0
Length of hospital stay, measured as time from admission to discharge, as recorded in the hospital's patient management index
Timepoint [3] 306120 0
At time of hospital discharge
Secondary outcome [4] 306121 0
Uterine hyperstimulation, defined as greater than or equal to 6 contractions every 10 minutes, lasting at least 20 minutes, as recorded on the CTG
Timepoint [4] 306121 0
At time of birth
Secondary outcome [5] 306122 0
Postpartum haemorrhage
Timepoint [5] 306122 0
At time of birth
Secondary outcome [6] 306123 0
VAS pain scores associated with insertion of PGE2 / balloon, and associated with ARM
Timepoint [6] 306123 0
At time of birth
Secondary outcome [7] 306124 0
Admission to neonatal nursery, length of nursery stay, length of neonatal hospital stay, as recorded in the hospital's patient management index
Timepoint [7] 306124 0
At time of hospital discharge of baby
Secondary outcome [8] 306125 0
Cord prolapse
Timepoint [8] 306125 0
At time of hospital admission
Secondary outcome [9] 306126 0
Maternal satisfaction will be recorded using a written survey based upon the patient satisfaction surveys used in a 2007 randomised trial of patient satisfaction comparing two inpatient induction methods. (Nassar A, Awwad J, Khalil A, Abu-Musa A, Mehio G, Usta I. (2007). A randomised comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labour at term. BJOG 114:1215–1221).
Timepoint [9] 306126 0
Post -partum, prior to hospital discharge
Secondary outcome [10] 306127 0
Total healthcare costs, using a DRG-based costing model yet to be developed
Timepoint [10] 306127 0
At time of hospital discharge

Eligibility
Key inclusion criteria
All women with live singleton pregnancies greater than or equal to 37 weeks 0 days, booked for induction of labour because of post-term and/or social/elective reasons, and requiring cervical priming will be suitable for inclusion in this study
Minimum age
18 Years
Maximum age
52 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major congenital abnormality
Multiple pregnancy
Intrauterine fetal death
Clinical suspicion or ultrasound diagnosis of fetal growth restriction
Any contraindication to vaginal birth
Indication for IOL other than post-term and/or social/elective reasons
Modified Bishops score = 7 at commencement of IOL
Women <18 years
Inability 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)
Potential participants will be identified by clinicians in the antenatal clinic at antenatal visits >=36 weeks 0 days. All low-risk women booked for IOL for post-term or social /elective reasons will be provided with written information regarding the trial, and will be given the opportunity to discuss the details of the study with a clinician or research midwife If they agree to participate they will provide a signed consent. One day prior to the booked IOL, the research midwife will contact the woman by phone and confirm that she still desires to be involved. The research midwife will then randomize the woman to one of two treatment arms, inform the woman of her treatment allocation, and file a staff information sheet in the medical record. The research midwife will keep a log of all potentially eligible participants and the reasons for participation or not as per CONSORT guidelines.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be according to computer-generated random allocation list into 2 study arms. Randomisation will be stratified by parity and by centre. A central computer randomisation service will be set-up by Mater Research, allowing research midwives in participating sites to randomise participants by phone. Randomisation will be performed approximately 24 hours prior to commencing the IOL.
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
Statistical analyses of the data will be performed by the investigators with support from Mater Research. The initial analysis will assess the adequacy of randomization procedure in ensuring comparability of the study groups. In this analysis demographic and other baseline characteristics will be compared. Primary and secondary outcomes will be assessed comparing the study groups. A subgroup analysis will be undertaken, comparing outcomes for nulliparous versus multiparous women. The Chi squared test will be used for categorical outcomes and student’s t-test for continuous data. If imbalance is identified in important baseline characteristics or demographics, a second analysis will be undertaken controlling for these factors using multivariate analysis. The level of significance for the primary outcome measures is set at 0.05 and Bonferroni adjustment for multiple comparisons will be undertaken for secondary outcome measures.

A sample size of 2500 will detect a 31% reduction in the composite neonatal outcome measure from 10.0% to 6.9%, with a power of 80% and a type 1 error of 0.05

These assumptions are derived from the reduction in incidence of arterial cord pH <7.1 reported in the Cochrane review of “Mechanical Methods for Induction of Labour”, the values reported in a recent Australian RCT “Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour”, and data from a recent audit of neonatal outcomes amongst low risk women being induced using PGE2 at MMH during 2011 (unpublished data). Presuming there are 25,000 births per annum across the seven participating centres, that the induction of labour rate is 26%, that 50% of inductions are undertaken because post-term or social / elective, and 50% of women would consent to participate, it will take approximately 19 months to achieve a sample size of 2500 women.

A sample size of 2500 women would also detect as small as a 0.2 OBD difference in length of stay, and as small as a 5% change in overall patient satisfaction

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2014
Actual
1/08/2015
Date of last participant enrolment
Anticipated
31/12/2019
Actual
31/10/2018
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
2500
Accrual to date
Final
695
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1872 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 1873 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 1877 0
Ipswich Hospital - Ipswich
Recruitment hospital [4] 1878 0
Caboolture Hospital - Caboolture
Recruitment hospital [5] 11460 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [6] 11461 0
Mackay Base Hospital - Mackay
Recruitment hospital [7] 11462 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 23480 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 23481 0
4740 - Mackay
Recruitment postcode(s) [3] 23482 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 288473 0
Charities/Societies/Foundations
Name [1] 288473 0
Mater Research UQ
Country [1] 288473 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Mater Research
Address
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 287172 0
None
Name [1] 287172 0
Address [1] 287172 0
Country [1] 287172 0
Other collaborator category [1] 277744 0
Commercial sector/Industry
Name [1] 277744 0
Australian Centre for Health Service Innovation
Address [1] 277744 0
Institute of Health and Biomedical Innovation
GPO Box 2434
BRISBANE QLD 4001
Country [1] 277744 0
Australia
Other collaborator category [2] 277745 0
Charities/Societies/Foundations
Name [2] 277745 0
Queensland Centre for Mothers and Babies
Address [2] 277745 0
Building 96, Hood Street
The University of Queensland
St Lucia, Queensland
4072
Country [2] 277745 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290337 0
Mater Health Services HREC
Ethics committee address [1] 290337 0
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [1] 290337 0
Australia
Date submitted for ethics approval [1] 290337 0
15/01/2014
Approval date [1] 290337 0
06/03/2014
Ethics approval number [1] 290337 0

Summary
Brief summary
Many babies arrive naturally in a timely manner, however, sometimes we need to assist (or ‘induce’) a pregnancy if there are any complications, or if the pregnancy goes well beyond the due date. It is estimated that one in four women have an induced labour. The induction of labour is commonly commenced by placing some hormone gel (called Prostaglandin) in the vagina to make the cervix (the opening of the womb into the vagina) softer and allow it to open. Induction of labour can also be commenced using a small tube with a balloon on the end, inserted through the cervix and then inflated to mechanically stretch the cervix. In Australia, both methods are commonly used to prepare the cervix for labour. Following either method, when the cervix is more open, contractions are brought on by breaking the waters around the baby (called artificial rupture of membranes or ARM) and administering a hormone fluid (called Syntocinon) intravenously (IV; or into a vein).

Sometimes, the induction process may be prolonged and it can take many hours, even days, before the cervix is more open. Prostaglandin hormone gel, in particular, can induce contractions. It is common practice that women undergoing induction remain an inpatient over this time. Balloon catheter induction is however very unlikely to induce contractions and there is even some published studies suggesting balloon catheter inductions may be associated with less chance of distress to babies. As such, for some women undergoing induction of labour with a low-risk, uncomplicated pregnancy, it would seem reasonable to go home after placement of the balloon catheter. The primary aim of the study is to demonstrate that going home after commencing an induction of labour using a balloon catheter is just as safe as having prostaglandin gel induction and remaining as an inpatient. We are additionally interested in the duration of labour, mode of birth, length of hospital stay, overall healthcare costs for women undergoing both induction policies, and which method is perceived by women to be more satisfactory.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 45146 0
Dr Michael Beckmann
Address 45146 0
Mater Health Services
Ground Floor, Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 45146 0
Australia
Phone 45146 0
+61 7 3163 1594
Fax 45146 0
Email 45146 0
[email protected]
Contact person for public queries
Name 45147 0
Dr Michael Beckmann
Address 45147 0
Mater Health Services
Ground Floor, Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 45147 0
Australia
Phone 45147 0
+61 7 3163 1594
Fax 45147 0
Email 45147 0
[email protected]
Contact person for scientific queries
Name 45148 0
Dr Michael Beckmann
Address 45148 0
Mater Health Services
Ground Floor, Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 45148 0
Australia
Phone 45148 0
+61 7 3163 1594
Fax 45148 0
Email 45148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial consent did not specify this potential secondary use


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
No additional documents have been identified.