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Trial registered on ANZCTR


Registration number
ACTRN12622001342707p
Ethics application status
Submitted, not yet approved
Date submitted
1/09/2022
Date registered
19/10/2022
Date last updated
19/10/2022
Date data sharing statement initially provided
19/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Easing Oxytocin in Early Labour (EASE-OUT) Trial
Scientific title
A Randomised Controlled Trial of Easing Oxytocin in Early Labour: Outcomes for Mothers and Babies - a feasibility study
Secondary ID [1] 307887 0
None
Universal Trial Number (UTN)
Trial acronym
EASE OUT TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour
 327518 0
Condition category
Condition code
Reproductive Health and Childbirth 324625 324625 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once informed, written consent has been obtained, participants will be entered into the study. Participants will be subsequently randomized into one of two groups to receive the trial intervention or routine care, either:

Intervention: 5IU oxytocin in 1L of normal saline or
Comparator (routine dose, standard care): 10IU oxytocin in 1L of normal saline

For both groups, doses be administered intravenously and will be titrated in mLs per hour as per NSW Health protocol by the midwife caring for the patient.

The intervention or routine (comparison) oxytocin preparation will be commenced when the active phase of the first stage of labour is first diagnosed (when there are regular uterine contractions and the cervix is 4cm dilated and the cervix is fully effaced). Regular contractions are considered to be contractions that occur at least every 4 minutes for at least one hour and are considered to be adequate by the midwife caring for the woman in labour.

The intervention will be ceased upon birth of the fetus or in the event the trial needs to be ceased and unblinded
Intervention code [1] 324346 0
Treatment: Drugs
Comparator / control treatment
1oIU of oxytocin in 1L of normal saline infused as per NSW Health Policy
Control group
Active

Outcomes
Primary outcome [1] 332443 0
Feasibility for a large multicenter trial will be the primary outcome of this pilot study, including:
- Any barriers encountered to recruitment - observational
- The mean total oxytocin dose per participant (to assess if the two treatment allocations result in a meaningful difference in the received dose of oxytocin) - will be collected from patient's medical records
- Number of potential participants assessed for eligibility - will be collected from audits of the study records
- Number of potential participants who agree to participate - will be collected from audits of the study records
- Number of participants randomised - will be collected from audits of the study records
- Final oxytocin infusion rates - will be collected from patient medical records
Timepoint [1] 332443 0
We expect the study to be completed in a 2-3 month period
Secondary outcome [1] 413522 0
- Satisfaction with birth experience will be assessed together using a VAS scale
Timepoint [1] 413522 0
Satisfaction with birthing experience using the VAS scale will be assess 4-6 weeks post-partum.
Secondary outcome [2] 413523 0
The following will be analysed as a composite outcome.
- Emergency caesarean section (including the subgroup of pregnant people with a previous caesarean section)
- Emergency caesarean section for fetal distress (where the primary indication is suspected fetal compromise as determined by the caring clinicians) (including the subgroup of pregnant people with a previous caesarean section)
- Emergency operative delivery for fetal distress (where the primary indication is suspected fetal compromise as determined by the caring clinicians)
Timepoint [2] 413523 0
Emergency caesarean section and emergency operative mode of delivery will be assessed within the process of labour and delivery outcomes may be determine by retrospective note review. Retrospect note view will occur approximately 3-6 months following enrollment cessation.
Secondary outcome [3] 413524 0
- Serious maternal morbidity or mortality (combined outcome), which includes the following: post-partum haemorrhage requiring blood transfusion, third or fourth degree perineal trauma; dilatation and curettage for bleeding or retained placental tissue; cervical laceration; vertical uterine incision; vulvar or perineal haematoma; pneumonia; venous thromboembolism requiring anticoagulation; wound infection requiring hospital stay more than 7 days; readmission to hospital for obstetric-related causes; wound dehiscence; maternal fever of at least 38.5°C on two occasions at least 24 hours apart not including the first 24 hours; bladder, ureter or bowel injury requiring repair; genital-tract fistula; bowel obstruction; or admission to intensive care unit. This will be reported as a proportion of participants with serious morbidity or mortality.
Timepoint [3] 413524 0
Serious maternal morbility will be determine via a retrospective note review and upon follow-up 4-6 weeks postpartum with patients.
Secondary outcome [4] 414357 0
Serious perinatal/neonatal morbidity or mortality within 6 weeks of birth (combined outcome), which will include the following: shoulder dystocia requiring manouvres other than McRoberts/suprapubic pressure or resulting in neonatal injury, 5-minute Apgars < 4; arterial cord pH <7.0 or lactate >10 or base excess < -15; seizures < 24 hours of age, intubation/ventilation >24 hours, tube feeding >4 days, admission to neonatal intensive care >4 days, neonatal jaundice requiring phototherapy, neonatal fracture, intraventricular/intracranial haemorrhage, subgaleal haemorrhage, neonatal blood transfusion, hypoxic ischaemic encephalopathy, or neuropraxia. This will be reported as a proportion of participants with serious morbidity or mortality.
Timepoint [4] 414357 0
Serious neonatal morbility will be determine via a retrospective note review and upon follow-up 4-6 weeks postpartum with patients.
Secondary outcome [5] 414868 0
Satisfaction with care in labour will be assessed together using a VAS scale
Timepoint [5] 414868 0
Satisfaction with care in labour using the VAS scale will be assess 4-6 weeks post-partum.

Eligibility
Key inclusion criteria
1. Age > 18 years
2. Planned induction of labour using oxytocin
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A fetus with a known major anomaly
2. “Red-Zone” (abnormal) fetal cardiotocograph according to NSW Health classification
3. Fetal breech, brow or face presentation
4. Clinical suspicion of cephalopelvic disproportion
5. Known or suspected chorioamnionitis
6. Intrapartum haemorrhage greater than 50mL
7. Intrapartum pyrexia greater than 38C
8. Fetal scalp pH less than 7.25 or lactate greater than 4
9. Pre-existing maternal diabetes
10. Previous caesarean section

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)
Superiority, double blinded, randomised controlled feasibility trial, Randomisation will be centrally controlled via a computerized randomization service (REDCap) that will be accessible 24 hours a day. Randomization will occur in a 1:1 ratio for the two arms of the trial and will be blocked by stratification variables (centre [Royal Prince Alfred/Canterbury] and parity [nulliparous/parous]). Randomization will occur immediately prior to the intervention.

It will be possible to reveal the treatment group if necessary at any point during the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis
Outcome measures between the intervention and comparator groups will be analyzed on an intention to treat basis, including withdrawals and losses to follow up.

The results will be reported according to consort guidelines (Schultz et al., 2022).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23065 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23066 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 38419 0
2050 - Camperdown
Recruitment postcode(s) [2] 38420 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 312160 0
Hospital
Name [1] 312160 0
Royal Prince Alfred Hospital
Country [1] 312160 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Road Camperdown 2050 NSW
Country
Australia
Secondary sponsor category [1] 313688 0
Other Collaborative groups
Name [1] 313688 0
Sydney Insitute for Women Children and Their babies
Address [1] 313688 0
50 Missenden Road Camperdown 2050 NSW
Country [1] 313688 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311551 0
Sydney Local Health District Ethics Committee
Ethics committee address [1] 311551 0
Royal Prince Alfred Hospital 50 Missenden Road Camperdown 2050 NSW
Ethics committee country [1] 311551 0
Australia
Date submitted for ethics approval [1] 311551 0
02/09/2022
Approval date [1] 311551 0
Ethics approval number [1] 311551 0

Summary
Brief summary
This research aims to improve outcomes for mothers and babies when a labour is artificially brought on or induced. Inducing the labour can lead to the baby being stressed and make the labour more painful. If the baby is severely stressed this can rarely lead to stillbirth or brain damage to the baby. This research will use lower doses of medications used to bring on labour, aiming to make it safer for mothers and babies. It could also reduce the chances
that a woman has a caesarean section
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121506 0
Dr Bradley De Vries
Address 121506 0
RPA Hospital - 50 Missenden Road Camperdown 2050 NSW
Country 121506 0
Australia
Phone 121506 0
+61 421087388
Fax 121506 0
Email 121506 0
bradley.devries@health.nsw.gov.au
Contact person for public queries
Name 121507 0
Dr Alanna Krisaanleela
Address 121507 0
RPA Hospital - 50 Missenden Road Camperdown 2050 NSW
Country 121507 0
Australia
Phone 121507 0
+61 425302105
Fax 121507 0
Email 121507 0
alanna.krisaanleela@health.nsw.gov.au
Contact person for scientific queries
Name 121508 0
Dr Alanna Krisaanleela
Address 121508 0
RPA Hospital - 50 Missenden Road Camperdown 2050 NSW
Country 121508 0
Australia
Phone 121508 0
+61 425302105
Fax 121508 0
Email 121508 0
alanna.krisaanleela@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data regarding the following
- Duration of labour
- Adverse outcome
- Number of caesarean sections
- Complications
- Neonatal or maternal morbidities
When will data be available (start and end dates)?
Post cessation of trial; no end date available
Available to whom?
Public
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Contact the PI via email at Bradley.deVries@health.nsw.gov.au


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.