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Trial registered on ANZCTR


Registration number
ACTRN12624000993594
Ethics application status
Approved
Date submitted
19/06/2024
Date registered
14/08/2024
Date last updated
14/08/2024
Date data sharing statement initially provided
14/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
OPTIMISing induction of labour care: oral misoprostol versus balloon dilatation within a stratified inpatient to outpatient setting [The OptiMis-IO study]
Scientific title
OPTIMISing induction of labour care: oral misoprostol versus balloon dilatation within a stratified inpatient to outpatient setting for pregnant woman with induction of labour [The OptiMis-IO study]
Secondary ID [1] 311408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 332685 0
Cervical Ripening 332686 0
Condition category
Condition code
Reproductive Health and Childbirth 329399 329399 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional care – Low-dose, oral misoprostol protocol.

a) Day 1 Present to hospital in morning for clinical examination, vaginal examination to determine modified Bishop’s score (MBS), fetal surveillance with cardiotocography (CTG) (Induction of Labour clinic). If modified bishops score is greater than or equal to 7, or artificial rupture of membrane (ARM) is deemed able to be performed, proceed with ARM and syntocinon regime when able. If not, then eight doses of 25 µg Misoprostol tablets taken orally two hours apart, with a cardiotocography (CTG) undertaken before the 3rd dose and then another CTG before the 8th dose (before bedtime), whilst an inpatient in the Maternity Inpatient Unit.

For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital).

b) Day 2 Repeat clinical examination (if not contracting, no vaginal examination indicated) and cardiotocography (CTG) in morning. If regular contractions have not started then proceed with a further 8 doses of 25 µg Misoprostol tablets taken orally two hours apart, with a cardiotocography (CTG) before the 9th and 14th doses, whilst an inpatient in the Maternity Inpatient Unit. If regular contractions, then would do vaginal examination with potential for artificial rupture of membrane (but ARM may not always be necessary if seeming to be established in labour). If contracting and cervix NOT fully effaced, then continue with drug protocol.

For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital).

c) Day 3 Clinical examination and cardiotocography. If regular contractions have not started or artificial rupture of membrane (ARM) is not possible then proceed with a further three doses of 25 µg Misoprostol tablets taken orally two hours apart.

For the outpatient trial, women who will receive the same dosage of Misoprostol tablets, will be discharged home with educational and support materials, inclusive of contact phone numbers, dosage regime and advice (when to come back or call the hospital).

If regular contractions have not started or artificial rupture of membrane (ARM) is not possible after 3 days, commence alternate/conventional local IOL protocol using mechanical (balloon catheter) cervical dilatation (see conventional care)
Intervention code [1] 327846 0
Treatment: Drugs
Comparator / control treatment
Conventional care - Mechanical (balloon catheter) cervical dilatation protocol.

a) Day 1 Present to hospital at 1500 hours for balloon catheter, Clinical Examination, Vaginal Examination (VE) to determine modified Bishop’s score (MBS), CTG. If MBS = 7 or artificial rupture of membrane (ARM) is deemed able to be performed proceed with ARM and syntocinon regime when able, otherwise midwife to insert balloon catheter with woman’s informed consent and admit her to Maternity Inpatient Unit.

b) Day 2 Clinical examination and CTG. ARM and commence syntocinon infusion as per local protocol. If ARM is not possible after (minimum) 12-hours of balloon catheter commence alternate IOL pathway as per local protocol.

If regular contractions have not started or artificial rupture of membrane (ARM) is not possible after mechanical (balloon catheter) cervical dilatation, patients will be advised options for care including:
1. further attempt to ripen the cervix with an alternative method (Dinoprostone gel up to 3 doses)
Cardiotocography (CTG) will be performed after each dose. Clinical examination and vaginal examination to determine modified Bishop's score will be performed 6 hours after each dose. If artificial rupture of membrane (ARM) is not possible, a repeat dose will be administered following normal cardiotography (CTG)
2. a rest period followed by re-assessment of the woman followed by 2nd attempt at IOL
3. caesarean section
Control group
Active

Outcomes
Primary outcome [1] 337211 0
Feasibility
Timepoint [1] 337211 0
Outcome will be assessed at the conclusion of the study/recruitment period
Primary outcome [2] 337212 0
Safety
Timepoint [2] 337212 0
This outcome will be assessed within 24 hours of birth of baby
Primary outcome [3] 338489 0
Acceptability
Timepoint [3] 338489 0
This outcome will be assessed within 2-4 weeks of birth
Secondary outcome [1] 436118 0
Mode of birth
Timepoint [1] 436118 0
Outcome will be assessed within 24 hours of birth
Secondary outcome [2] 437317 0
Oxytocin infusion
Timepoint [2] 437317 0
Outcome will be assessed within 24 hours of birth
Secondary outcome [3] 437319 0
Number of Induction of labour agents needed
Timepoint [3] 437319 0
Outcome will be assessed within 24 hours of birth
Secondary outcome [4] 437320 0
Uterine hyperstimulation
Timepoint [4] 437320 0
Outcome will be assessed within 24 hours of birth
Secondary outcome [5] 437321 0
Damage to internal organs (bowel, bladder or ureters)
Timepoint [5] 437321 0
Outcome will be assessed within 48 hours of birth of baby
Secondary outcome [6] 437323 0
Hysterectomy from any complications resulting from birth
Timepoint [6] 437323 0
Outcome will be assessed within 48 hours of birth
Secondary outcome [7] 437325 0
Maternal inpatient length of stay
Timepoint [7] 437325 0
Outcome will be assessed at conclusion of the trial (8 weeks after birth)
Secondary outcome [8] 437328 0
APGARS (at 5 minute)
Timepoint [8] 437328 0
Outcome will be assessed within 24 hours of birth
Secondary outcome [9] 437329 0
Death, fetal or within 28 days after birth
Timepoint [9] 437329 0
Outcome will be assessed at conclusion of the trial (8 weeks after birth)
Secondary outcome [10] 437332 0
Breastfeeding at discharge
Timepoint [10] 437332 0
Outcome will be assessed at conclusion of the trial (8 weeks after birth)

Eligibility
Key inclusion criteria
Live fetus, singleton pregnancy, cephalic presentation, planning a vaginal birth, labour initiated by induction of labour, intact membranes, normal cardiotocography, Modified Bishops Score less than 7 (or ARM not possible), 16 years or older, informed consent to participate (which includes a vaginal examination prior to induction of labour) and intention to follow recommended care. Participants who meet inclusion criteria who are from non-English speaking background and/or culturally diverse backgrounds will be offered interpreters and cultural support during recruitment and consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous uterine surgery, major fetal congenital anomaly, suspected severe fetal growth restriction, decline to participate, planned caesarean section and non-English speakers without interpreter.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised within parity strata 1:1 using permuted block sizes of 2, 4 and 6.
We anticipate 140 participants per trial (inpatient and outpatient), with 35 nulliparous and 35 multiparous participants in each treatment group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2026
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26712 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 42751 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 315669 0
Government body
Name [1] 315669 0
Wishlist-SERTF Research Grant
Country [1] 315669 0
Australia
Primary sponsor type
Government body
Name
Womens' and Childrens' Service, Sunshine Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 317772 0
None
Name [1] 317772 0
Address [1] 317772 0
Country [1] 317772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314547 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314547 0
[email protected]
Ethics committee country [1] 314547 0
Australia
Date submitted for ethics approval [1] 314547 0
08/02/2024
Approval date [1] 314547 0
28/05/2024
Ethics approval number [1] 314547 0
HREC/2024/MNHA/105360

Summary
Brief summary
Around 35% of labours are induced, and the rates are rapidly rising. Most induction start with 'cervical ripening', traditionally an invasive procedure with a balloon device or hormonal medication administered vaginally in hospital. Low-dose oral misoprostol is a promising alternative - less invasive, can be administered in an outpatient setting, and associated with fewer caesarean sections and equivalent rates of uterine stimulation compared to balloon methods. However, limited clinical trials have directly compared it to balloon methods, none within an outpatient setting. Therefore, we will compare low-dose, oral misoprostol with balloon methods for induction of labour to determine intervention feasibility and acceptability within two-discrete randomised controlled trials within the Sunshine Coast University Hospital and Royal Brisbane and Womens' Hospital.

As the context of the intervention (inpatient or outpatient) is likely to influence outcomes, an initial study will be used to assess feasibility and ensure safety and acceptability in the inpatient setting and if it meets a priori criteria the second study will be conducted to demonstrate the same measure in an outpatient setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131974 0
Dr Rachael Nugent
Address 131974 0
Sunshine Coast University Hospital, 6 Doherty Street, Birtinya, QLD 4575
Country 131974 0
Australia
Phone 131974 0
+61 07 5202 2933
Fax 131974 0
Email 131974 0
[email protected]
Contact person for public queries
Name 131975 0
Rachael Nugent
Address 131975 0
Sunshine Coast University Hospital, 6 Doherty Street, Birtinya, QLD 4575
Country 131975 0
Australia
Phone 131975 0
+61 07 5202 2933
Fax 131975 0
Email 131975 0
[email protected]
Contact person for scientific queries
Name 131976 0
Rachael Nugent
Address 131976 0
Sunshine Coast University Hospital, 6 Doherty Street, Birtinya, QLD 4575
Country 131976 0
Australia
Phone 131976 0
+61 07 5202 2933
Fax 131976 0
Email 131976 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 of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator. contact [email protected]


What supporting documents are/will be available?




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.