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Trial registered on ANZCTR


Registration number
ACTRN12621001328864
Ethics application status
Approved
Date submitted
30/06/2021
Date registered
29/09/2021
Date last updated
30/08/2022
Date data sharing statement initially provided
29/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and safety of outpatient versus inpatient balloon cervical ripening preceding induction of labour
Scientific title
Effectiveness and safety of outpatient versus inpatient balloon cervical ripening preceding induction of labour
Secondary ID [1] 304657 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROBAAT-HOME (Prospective study of Outpatient BAlloon At Term)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
induction of labour 322621 0
cervical ripening 322622 0
Condition category
Condition code
Reproductive Health and Childbirth 320243 320243 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completion of mechanical cervical ripening (with a balloon catheter) in the outpatient (home) setting.

Data collection will be prospective or retrospective depending on whether the participating centre has commenced outpatient cervical ripening. If the centre is already performing outpatient cervical ripening, data concerning the cervical ripening process and the subsequent labour and delivery will be collected. If the centre has not yet commenced outpatient cervical ripening, data will be collected at the time of presentation for cervical ripening and subsequently for labour and delivery.

Data collection will centre on admission for induction of labour, where routine hospital inpatient data collected would include information on the participants personal and antenatal medical history. Therefore, the time period would be isolated to this admission.

There are no further planned follow up attendance required.

A subgroup of participants who will complete a maternal satisfaction questionnaire will do so during their normal post-natal stay. We aim to collect a questionnaire from 100 or more participants (50 from each arm). Participants will be selected by convenience sampling - women will be approached on the post-natal ward about voluntary participation in the questionnaire at participating sites.


Intervention code [1] 321022 0
Not applicable
Comparator / control treatment
Completion of mechanical cervical ripening (with a balloon catheter) in the inpatient setting
Control group
Active

Outcomes
Primary outcome [1] 328103 0
Achievement of vaginal birth (assisted or unassisted), calculated as proportion of the total number of deliveries in women undergoing cervical ripening with a balloon catheter.

This information will be collected from routine hospital records.
Timepoint [1] 328103 0
Participants will be followed up from the time of cervical ripening until birth is achieved, whether it is vaginal delivery or caesarean section. There is no specific time frame allocated to this, however it would be reasonable to assume it would not extend beyond a 7 day period.
Secondary outcome [1] 397637 0
The main secondary outcome will measure safety, by use of a composite of poor neonatal outcome, defined as one or more of perinatal mortality, 5-minute Apgar score <4, or neonatal special care or intensive care unit (NICU) admittance for more than 48 hours
Timepoint [1] 397637 0
These outcomes will be monitored from time of delivery until hospital discharge of the mother.
Secondary outcome [2] 400340 0
An additional secondary outcome will be maternal satisfaction. This will be measured with a qualitative questionnaire adapted from previous research on labour, which will ask about the experience of induction of labour.
Timepoint [2] 400340 0
Assessed by discharge from the post-natal ward (usually 1-3 days after delivery).

Eligibility
Key inclusion criteria
1. For health centres: to be currently performing inpatient cervical ripening with balloon catheters prior to induction of labour at term.
2. For individuals: All women undergoing induction of labour at or after 37 weeks of gestation with an unfavourable cervix requiring balloon cervical ripening (Bishop score < 7). Singleton pregnancy with no major fetal structurally abnormality, cephalic (head-first) presentation and intact membranes.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Induction of labour before 37 weeks of gestation, major fetal structural abnormalities, intrauterine fetal death, multiple pregnancies, anomalous (non-cephalic) presentation, induction of labour without cervical ripening, utilisation of other pharmacological methods (prostaglandins) for cervical ripening when cervical ripening with balloon is contra-indicated or when the placement of the balloon is technically not possible, and necessity of hospital admission for other medical reasons prior to and during the balloon cervical ripening (in both phases).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Statistical analyses will be conducted according to the intention-to-treat (ITT) principle, including all women booked for induction of labour with planned balloon cervical ripening during the study period. Women who are kept in hospital during the outpatient phase due to other medical reasons or opted out of the study will also be included in the ITT analysis. A per-protocol analysis will also be carried out including only participant who received the intervention they were allocated to. For non-inferiority testing, a one-sided test at the 0.025 level of significance will be used.
Baseline characteristics will be given by descriptive analysis, and the balance between the two arms will be assessed. For continuous variables, the data will be assessed for normality. Differences in dichotomous outcome measures will be compared using generalised linear mixed model logistic regression to estimate the odds ratios (OR) and 95% confidence interval (CI) for the intervention period compared to the control period. Differences in continuous outcomes will be analysed with linear mixed model with the same random and fixed effects, and the intervention effect will be expressed as mean difference (MD) and 95% CI. The study will be powered for its primary outcomes, no adjustments for multiple comparisons will be made and no interim analyses are planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
3672
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 19849 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 19850 0
Casey Hospital - Berwick
Recruitment hospital [3] 19851 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 19852 0
The Royal Women's Hospital - Parkville
Recruitment hospital [5] 19853 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 19854 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [7] 19855 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [8] 19856 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 19857 0
Gawler Health Service - Gawler East
Recruitment hospital [10] 19858 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [11] 19859 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [12] 19860 0
The Canberra Hospital - Garran
Recruitment hospital [13] 19861 0
The Northern Hospital - Epping
Recruitment hospital [14] 19862 0
Sunshine Hospital - St Albans
Recruitment hospital [15] 19863 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 34548 0
3168 - Clayton
Recruitment postcode(s) [2] 34549 0
3806 - Berwick
Recruitment postcode(s) [3] 34550 0
3175 - Dandenong
Recruitment postcode(s) [4] 34551 0
3052 - Parkville
Recruitment postcode(s) [5] 34552 0
3128 - Box Hill
Recruitment postcode(s) [6] 34553 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [7] 34554 0
6112 - Armadale
Recruitment postcode(s) [8] 34555 0
2065 - St Leonards
Recruitment postcode(s) [9] 34556 0
5118 - Gawler East
Recruitment postcode(s) [10] 34557 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 34558 0
2077 - Hornsby
Recruitment postcode(s) [12] 34559 0
2605 - Garran
Recruitment postcode(s) [13] 34560 0
3076 - Epping
Recruitment postcode(s) [14] 34561 0
3021 - St Albans
Recruitment postcode(s) [15] 34562 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 309022 0
Hospital
Name [1] 309022 0
Monash Health
Country [1] 309022 0
Australia
Primary sponsor type
Individual
Name
Madeleine Jones
Address
Department of Obstetrics & Gynaecology
Monash University
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 309959 0
None
Name [1] 309959 0
Address [1] 309959 0
Country [1] 309959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308905 0
Monash Health HREC
Ethics committee address [1] 308905 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 308905 0
Australia
Date submitted for ethics approval [1] 308905 0
Approval date [1] 308905 0
15/06/2020
Ethics approval number [1] 308905 0
RES-20-0000-038A

Summary
Brief summary
Induction of labour (IOL) is one of the most frequent obstetric interventions, being performed in more than 100,000 pregnant women in Australia every year. The first phase of IOL consists of preparation of the cervix, which is often done with the placement of a balloon catheter through the birth canal for 12-24 hours. This procedure is effective, safe and generally performed in hospital. This study will not only investigate whether cervical ripening with a balloon catheter can be performed safely and effectively at home after insertion in hospital, but also establish a network of obstetric services in Australia. If we show that cervical ripening with a balloon catheter can be safely and effectively performed at home, this will reduce significantly the number of admissions and healthcare costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112290 0
Prof Ben W. Mol
Address 112290 0
Monash University
246 Clayton Rd
Clayton VIC 3168
Country 112290 0
Australia
Phone 112290 0
+61 385723948
Fax 112290 0
Email 112290 0
[email protected]
Contact person for public queries
Name 112291 0
Madeleine Jones
Address 112291 0
Monash University
246 Clayton Rd
Clayton VIC 3168
Country 112291 0
Australia
Phone 112291 0
+61 428000266
Fax 112291 0
Email 112291 0
[email protected]
Contact person for scientific queries
Name 112292 0
Madeleine Jones
Address 112292 0
Monash University
246 Clayton Rd
Clayton VIC 3168
Country 112292 0
Australia
Phone 112292 0
+61 428000266
Fax 112292 0
Email 112292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data after de-identification
When will data be available (start and end dates)?
Data will be available for sharing after analysis is complete and findings have been published, with no planned end date for availability.
Available to whom?
Researchers may contact the study team to discuss data-sharing for appropriate research proposals
Available for what types of analyses?
To be discussed on a case-by-case basis
How or where can data be obtained?
Contacting the research team at [email protected]


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.