Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000388112
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
12/03/2019
Date last updated
16/04/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening and Induction of Labour: OUTcomes for mothers and babies
Scientific title
Induction of Labour at 39 week's gestation for women at high risk of Caesarean Section for slow progress of labour - A pilot randomised controlled trial
Secondary ID [1] 297508 0
None
Universal Trial Number (UTN)
Trial acronym
SAIL-OUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Term Pregnancy 311701 0
Induction of Labour 311703 0
Caesarean Section 311829 0
Condition category
Condition code
Reproductive Health and Childbirth 310325 310325 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 310488 310488 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women eligible for randomisation who screen high risk of caesarean section for slow progress in labour will be offered randomisation for two arms: induction of labour at 39 week's vs continuation of normal pregnancy care.
The intervention is induction of labour in the 39th week of pregnancy. The consent for induction will be undertaken by the research team (doctor or midwife) and the induction process will be undertaken as per local health policy guidelines by clinical midwives or doctors with cervical ripening using Prostoglandin E2 and/or cook's balloon catheter (if Bishop score <7) with appropriate external fetal monitoring followed by artificial rupture of membranes and syntocinon with appropriate fetal monitoring (as needed).
There are one to two slots per week allocated for this pilot which are seperate to the normal induction bookings as not to interfere with normal induction booking process. The day of labour induction in the 39th week will be decided based on both participant preference as well as labour ward acuity (including other booked indicated induction, staffing allowances, preferred weekday slots and emergencies) to ensure that patient safety is not compromised.
Given this is a pilot study to assess feasibility, intervention fidelity (ie induction in the 39th week) will be assessed both qualitatively with a patient satisfaction questionnaire and quantitatively through audit of medical records.
Intervention code [1] 313806 0
Early detection / Screening
Intervention code [2] 313807 0
Prevention
Comparator / control treatment
Active Control: continuation of normal pregnancy care.
Normal pregnancy care encompasses routine ultrasound review and weekly review of patients. If complications of pregnancy develop, patients will undergo appropriate review, investigation and management by clinicians (midwives and doctors who are not nominated research staff). Review may lead to the possibility of medically indicated induction of labour or emergency caesarean section prior to onset of spontaneous labour. After delivery, medical records will be audited.
Control group
Active

Outcomes
Primary outcome [1] 319300 0
Proportion of women who are approached that participate

Timepoint [1] 319300 0
36+0/40-37+6/40 weeks gestation
Primary outcome [2] 319301 0
Proportion of women who are approached that are randomised
Timepoint [2] 319301 0
36+0/40-37+6/40 weeks gestation
Secondary outcome [1] 367625 0
Caesarean section for slow progress in labour assessed via data-linkage to medical records
Timepoint [1] 367625 0
Delivery
Secondary outcome [2] 367626 0
Caesarean section rate (overall) assessed via data-linkage to medical records
Timepoint [2] 367626 0
Delivery
Secondary outcome [3] 367627 0
Instrumental birth rate assessed via data-linkage to medical records
Timepoint [3] 367627 0
Delivery
Secondary outcome [4] 367628 0
Obstetric anal sphincter injury assessed via data-linkage to medical records
Timepoint [4] 367628 0
Delivery
Secondary outcome [5] 367629 0
Post-partum haemorrhage assessed via data-linkage to medical records
Timepoint [5] 367629 0
Delivery
Secondary outcome [6] 367630 0
Length of labour assessed via data-linkage to medical records
Timepoint [6] 367630 0
Delivery
Secondary outcome [7] 367631 0
Analgesia in labour assessed via data-linkage to medical records
Timepoint [7] 367631 0
Delivery
Secondary outcome [8] 367632 0
Length of hospital stay assessed via data-linkage to medical records
Timepoint [8] 367632 0
6 weeks postpartum
Secondary outcome [9] 367633 0
Breastfeeding on discharge assessed via data-linkage to medical records
Timepoint [9] 367633 0
6 weeks postpartum
Secondary outcome [10] 367634 0
Gestational age at birth assessed via data-linkage to medical records
Timepoint [10] 367634 0
Delivery
Secondary outcome [11] 367635 0
Oxytocin use in labour assessed via data-linkage to medical records
Timepoint [11] 367635 0
Delivery
Secondary outcome [12] 367636 0
5 min APGAR score assessed via data-linkage to medical records
Timepoint [12] 367636 0
Delivery
Secondary outcome [13] 367917 0
Admission to NICU assessed via data-linkage to medical records
Timepoint [13] 367917 0
Delivery to 6 weeks postpartum
Secondary outcome [14] 367918 0
Abnormal umbilical arterial cord blood gases assessed via data-linkage to medical records
Timepoint [14] 367918 0
Delivery

Eligibility
Key inclusion criteria
- Pregnant
- Female
- Greater than 18 years
- Planned vaginal birth
- Cephalic presentation
- Screening ultrasound at 36+0 to 37+6 weeks gestation for fetal biometry, amniotic fluid index and metal Doppler studies
- Positive screen risk for caesarean section for failure to progress in labour
- Potential participants with a risk of caesarean section for abnormal progress in labour of >= 28% will be eligible to participate
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planned induction of labour before the estimated date of confinement
- Previous caesarean section or uterine incision
- Any indication for elective caesarean section
- Known major anatomic fetal abnormality
- Any contraindication for induction of labour

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed as block randomisation with a 1:1 allocation.
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
Analysis will be by intention to treat (according to treatment allocation), including withdrawals and losses to follow up.
The results will be reported according to CONSORT guidelines.
Demographics and other potential confounders will be compared by treatment allocation in a univariate analysis. Categorical outcome measures will be compared by proportions (chi-squared test), means for normally distributed data (t-test), or rank order for non-normally distributed data (Wilcoxon rank sum test).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13306 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25857 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302067 0
Hospital
Name [1] 302067 0
Royal Prince Alfred Hospital Women and Babies
Country [1] 302067 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Women and Babies
Address
50 Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 301883 0
None
Name [1] 301883 0
Address [1] 301883 0
Country [1] 301883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302748 0
Sydney Local Health District Human Research Ethics Committee - RPAH
Ethics committee address [1] 302748 0
RPAH Medical Centre
Suite 210A, Level 2
100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 302748 0
Australia
Date submitted for ethics approval [1] 302748 0
14/09/2018
Approval date [1] 302748 0
01/11/2018
Ethics approval number [1] 302748 0
Protocol No X18-0343 & HREC/18/RPAH/482

Summary
Brief summary
The caesarean section (CS) rate has risen to the point where a third of all mothers in Australia give birth by this method [1]. CS is a major contributing factor to maternal mortality and morbidity following childbirth in developed countries and reducing the overall CS rate is a major policy goal for NSW Health [2].
The highest risk of adverse outcomes associated with CS occurs when it is performed during labour which is 40% of all CSs[1, 3]. Most of these are due to failure to progress (FTP) which accounts for around 8% of all births[3].
Induction of labour (IOL) reduces the risk of CS, particularly when there is a low risk of fetal distress [4, 5], but it is not feasible to offer this intervention to all women because given time, most women will labour naturally. To date, there is no method of prospectively identifying women who are most likely to benefit from IOL.
Predictive models could identify women who might benefit from preventative measures such as induction of labour.
We have created a model which will be used to screen for women at high risk of caesarean section in labour. This model incorporates maternal age, body mass index (BMI), height, gestational diabetes, estimated fetal weight, amniotic fluid index, and parity.
We will be investigating if induction of labour compared with routine antenatal care at 39 weeks of gestation in women with a cephalic presenting fetus reduces the risk of caesarean section for abnormal progress in labour.

References:
1.Hilder, L., et al., Australia's mothers and babies 2012. Perinatal statistics series no. 30. Canberra: AIHW, in Australia's mothers and babies 2012.
2. Health, N., Maternity - Towards normal birth in NSW, N. Ministry of Health, Editor. 2010.
3. Zhang, J., et al., Contemporary cesarean delivery practice in the United States. Am J Obstet Gynecol, 2010. 203(4): p. 326 e1-326 e10.
4. Gülmezoglu, A.M., et al., Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database of Systematic Reviews, 2012(6).
5. Boers, K.E., et al., Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ, 2010. 341: p. c7087.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91262 0
Dr Bradley De Vries
Address 91262 0
Women and Babies
RPAH
50 Missenden Road
Camperdown NSW 2050
Country 91262 0
Australia
Phone 91262 0
+61 02 9515 6111
Fax 91262 0
Email 91262 0
Bradley.DeVries@health.nsw.gov.au
Contact person for public queries
Name 91263 0
Dr Jessica Jellins
Address 91263 0
Fetal Medicine Unit
Women and Babies
RPAH
50 Missenden Road
Camperdown NSW 2050
Country 91263 0
Australia
Phone 91263 0
+61 02 9515 6111
Fax 91263 0
Email 91263 0
jessica@jellins.com
Contact person for scientific queries
Name 91264 0
Dr Jessica Jellins
Address 91264 0
Fetal Medicine Unit
Women and Babies
RPAH
50 Missenden Road
Camperdown NSW 2050
Country 91264 0
Australia
Phone 91264 0
+61 02 9515 6111
Fax 91264 0
Email 91264 0
jessica@jellins.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study


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.