Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000161729
Ethics application status
Not yet submitted
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhanced care and support in early labour (ecsel) trial
Scientific title
Enhanced care and support in early labour (ecsel): a randomised controlled trial to reduce caesarean sections for first-time mothers.
Secondary ID [1] 259791 0
nil
Universal Trial Number (UTN)
Trial acronym
ecsel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Birth by caesarean section 256895 0
Condition category
Condition code
Reproductive Health and Childbirth 257043 257043 0 0
Childbirth and postnatal care
Public Health 257044 257044 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard care in early labour is to telephone the midwife in the hospital birthsuite and seek advice on whether or not to come to hospital. The intervention here is that a known midwife will provide enhanced support (via telephone and/or home visiting) to assist women in the early or latent phases of labour to remain at home until labour is well established unless there is a reason to be admitted earlier. The support will include listening to the woman, taking a detailed history, assessing her current stage of labour and coping ability, advising whether or not to come to hospital, suggesting pain relief strategies and providing reassurance. This will be the midwife's main role, whereas midwives usually providing such guidance are concurrently providing care to women already admitted to hospital in labour. The study midwife will also visit the woman at home if this would be helpful (to be decided on an individual basis by the woman and the midwife). The duration of this additional support will vary according to individual needs between around 15 minutes and 3 hours.
Intervention code [1] 256090 0
Prevention
Intervention code [2] 286488 0
Treatment: Other
Comparator / control treatment
Women telephone midwives working in birthsuite/emergency department when they want advice re admission to hospital for the birth (standard care).
Control group
Active

Outcomes
Primary outcome [1] 257931 0
Caesarean section for any indication (collected by data abstraction from the medical record)
Timepoint [1] 257931 0
Index birth
Secondary outcome [1] 263430 0
Instrumental vaginal birth (collected by data abstraction from the medical record)
Timepoint [1] 263430 0
Index birth
Secondary outcome [2] 263431 0
Length of time from hospital admission to birth (collected by data abstraction from the medical record)
Timepoint [2] 263431 0
Index birth
Secondary outcome [3] 263432 0
Admission to hospital with cervical dilatation <5cm (collected by data abstraction from the medical record)
Timepoint [3] 263432 0
Index labour
Secondary outcome [4] 263433 0
Use of oxytocin infusion to induce or augment labour (collected by data abstraction from the medical record)
Timepoint [4] 263433 0
Index labour
Secondary outcome [5] 263434 0
Cost of maternity care (collected via postal questionnaire at 6 weeks after the birth and data abstraction from the medical record)
Timepoint [5] 263434 0
From first possible sign of labour until disharge from hospital following the birth.
Secondary outcome [6] 263435 0
Use of epidural analgesia for relief of pain in labour (excluding that used solely as anaesthesia to facilitate operative birth) (collected by data abstraction from the medical record)
Timepoint [6] 263435 0
Index labour
Secondary outcome [7] 263436 0
Postpartum haemorrhage (collected by data abstraction from the medical record)
Timepoint [7] 263436 0
In the 24 hours following the index birth.
Secondary outcome [8] 263437 0
Apgar score <7 at 5 minutes after birth. This is a measure of the condition of the newborn baby at, and soon after, birth (collected by data abstraction from the medical record). Change made prior to the commencement of recruitment.
Timepoint [8] 263437 0
5 minutes after birth
Secondary outcome [9] 301050 0
Maternal satisfaction with intrapartum care (collected via postal questionnaire at 6 weeks after the birth)
Timepoint [9] 301050 0
6 weeks postnatal
Secondary outcome [10] 301051 0
Birth before arrival at hospital (collected by data abstraction from the medical record)
Timepoint [10] 301051 0
Index birth
Secondary outcome [11] 301052 0
Exclusive breastfeeding (collected via postal questionnaire at 6 weeks after the birth).
Timepoint [11] 301052 0
6 weeks postnatal
Secondary outcome [12] 301053 0
Neonatal admission to special care or neonatal intensive care (collected by data abstraction from the medical record)
Timepoint [12] 301053 0
Index birth
Secondary outcome [13] 301054 0
Maternal admission to high-dependency care (collected by data abstraction from the medical record)
Timepoint [13] 301054 0
Within 24 hours of the index birth
Secondary outcome [14] 301055 0
Neonatal resuscitation more intensive than oxygen and/or suction (collected by data abstraction from the medical record)
Timepoint [14] 301055 0
At the index birth
Secondary outcome [15] 301056 0
Score >12 on Edinburgh Postnatal Depression Scale (collected via postal questionnaire at 6 weeks after the birth)
Timepoint [15] 301056 0
6 weeks postnatal

Eligibility
Key inclusion criteria
Women at normal risk of complication having their first baby booked at a participating hospital; live within 30 minutes drive of the hospital; English speaking.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Complications of pregnancy that would indicate early admission to hospital in labour e.g. fetal growth restriction, antepartum haemorrhage, planned caesarean section

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)
Women will be approached at 36 weeks' gestation and informed about the study. Written informed consent will be obtained if they choose to take part. Background data will be collected, then the recruiter will contact an independent randomisation service to obtain the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by site; variable block sizes; 1:1 allocation to intervention:control
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 by intention-to-treat

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286702 0
Government body
Name [1] 286702 0
applied for NHMRC Project grant funding
Country [1] 286702 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Scenic Blvd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 285473 0
None
Name [1] 285473 0
Address [1] 285473 0
Country [1] 285473 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288769 0
Human Ethics Committee, Monash University
Ethics committee address [1] 288769 0
Ethics committee country [1] 288769 0
Australia
Date submitted for ethics approval [1] 288769 0
29/04/2019
Approval date [1] 288769 0
Ethics approval number [1] 288769 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30887 0
Dr Mary-Ann Davey
Address 30887 0
Department of Obstetrics and Gynaecology, Monash University
246 Clayton Rd
Clayton, Vic 3168
Country 30887 0
Australia
Phone 30887 0
+61439615732
Fax 30887 0
Email 30887 0
[email protected]
Contact person for public queries
Name 14134 0
Mary-Ann Davey
Address 14134 0
Department of Obstetrics and Gynaecology, Monash University
246 Clayton Rd
Clayton, Vic 3168
Country 14134 0
Australia
Phone 14134 0
+61439615732
Fax 14134 0
Email 14134 0
[email protected]
Contact person for scientific queries
Name 5062 0
Mary-Ann Davey
Address 5062 0
Department of Obstetrics and Gynaecology, Monash University
246 Clayton Rd
Clayton, Vic 3168
Country 5062 0
Australia
Phone 5062 0
+61439615732
Fax 5062 0
Email 5062 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?
To be decided in the context of any request made.
When will data be available (start and end dates)?
Trial not yet funded, so dates unknown. Beginning 3 months and ending 5 years following main results publication.
Available to whom?
case-by-case basis at the discretion of chief investigator
Available for what types of analyses?
IPDMA. To be decided in the context of any request made.
How or where can data be obtained?
access subject to approvals by Chief Investigator


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.