Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000238976
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
25/02/2020
Date last updated
25/02/2020
Date data sharing statement initially provided
25/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Birth Environment Design Study for Pregnant Women
Scientific title
The Birth Environment Design (BED) study: A Randomized Controlled Trial (RCT) of ‘changed’ or ‘standard’ birth environment during labour and birth in a low-risk cohort.
Secondary ID [1] 300433 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
BED Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Pregnant Women 316088 0
Condition category
Condition code
Reproductive Health and Childbirth 314368 314368 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Changed Room
In the intervention arm the bed will be pushed to the side of the room, the resuscitaire will be moved outside the room, birth mats, bean bags and birth balls will be placed in the centre of the room; music will be started; blinds will be closed; the door of the birth room will be closed and a ‘please knock & enter quietly’ sign displayed; lighting decreased and access to water encouraged.
The preparation of the room will take 5-10 minutes for the midwife to complete prior to the woman entering the room. Restrictions will not be placed on the woman; she should be facilitated to use any equipment (including the bed if she desires). If the circumstances of her labour change and access to the bed is required, (e.g. emergency instrumental delivery) health professionals will revert to the standard room. There will be no restrictions placed on minimum or maximum time spent in the room and will be at the discretion of the health professionals involved in the woman's care. Midwives will document room changes and adherence to intervention in both the routinely collected electronic medical records as well as on the Midwifery Survey which is completed by the midwife for each study participant.
Intervention code [1] 316728 0
Prevention
Intervention code [2] 316729 0
Behaviour
Comparator / control treatment
Control Group: Standard Obstetric Room
Women randomised to the control arm will be assigned to a standard room (bed in the centre of the room, alternative birth equipment stored in a separate room, lights not dimmed). Women should not be prevented from utilising alternative birthing equipment if she desires.
Control group
Active

Outcomes
Primary outcome [1] 322733 0
The primary outcome is mobility in labour as assessed by the study-specific 'Maternal Positions Form" which is contemporaneously completed by the midwife and documents predominant maternal position every 30 minutes and whether this position occurs on or off the bed.
Timepoint [1] 322733 0
Mobility of woman in active labour will be assessed contemporaneously. Birth Unit Midwives will be asked to complete a form documenting maternal position every 30 minutes and further information will also be gained by the completion of the postnatal survey by both the midwives and woman.
Secondary outcome [1] 379486 0
Pharmaceutical analgesia -extracted from E-maternity (routinely collected data)
Timepoint [1] 379486 0
48 hours after birth
Secondary outcome [2] 379928 0
Birth Position -Extracted from E-maternity (routinely collected data)
Timepoint [2] 379928 0
48 hours after birth
Secondary outcome [3] 379929 0
Length of Labour (first, second and third stage) - Extracted from E-maternity (routinely collected data)
Timepoint [3] 379929 0
48 hours after birth
Secondary outcome [4] 379930 0
Mode of Birth - Extracted from E-maternity (routinely collected data)
Timepoint [4] 379930 0
48 hours after birth
Secondary outcome [5] 379931 0
Perineal Outcomes - Extracted from E-maternity (routinely collected data)
Timepoint [5] 379931 0
48 hours after birth
Secondary outcome [6] 379932 0
Post-partum Hemorrhage (PPH) - Extracted from E-maternity (routinely collected data)
Timepoint [6] 379932 0
48 hours after birth
Secondary outcome [7] 379933 0
Use of synthetic oxytocin - Extracted from E-maternity (routinely collected data)
Timepoint [7] 379933 0
48 hours after birth
Secondary outcome [8] 379934 0
Length of Hospital Stay - Extracted from electronic medical records (routinely collected data)
Timepoint [8] 379934 0
14 days after birth
Secondary outcome [9] 379935 0
Maternal Satisfaction - study specific questionnaire 'Pregnant Woman Survey"
Timepoint [9] 379935 0
Within 48 hours of birth
Secondary outcome [10] 379936 0
Midwifery Evaluation - study specific questionnaire "Midwifery Survey'
Timepoint [10] 379936 0
Within 48 hours of birth

Eligibility
Key inclusion criteria
Inclusion/Exclusion Criteria
The National Midwifery Guidelines for Consultation and Referral (ACM 2015) provide information to midwives to assist with integrating evidence into their clinical care and to aid midwives in their discussions with women regarding different maternity care options. Pregnancy or medical conditions are labelled as either A, A*, B or C.
A or A*: Discuss the situation with a colleague, and/or medical practitioner. A* is the category for midwives endorsed to prescribe scheduled medicines and order diagnostic or screening tests (ACM, 2015, p.22).
B: Consult with a medical practitioner or other health care provider (ACM, 2015, p.22).
C: Refer a woman or her infant to a medical practitioner for secondary or tertiary care (ACM, 2015, p.22).
Inclusion Criteria
• 18 years or older at time of recruitment
• Experiencing a low-risk pregnancy and classified as either category A/A* or B under the National Midwifery Guidelines for Consultation and Referral (ACM 2015)
• Greater than 36 weeks gestation
• Planning a vaginal birth
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• High-risk pregnancy classified as either category C under the National Midwifery Guidelines for Consultation and Referral (ACM 2015).
• If the woman is recruited while she is classified as low risk but during her pregnancy develops into a high-risk patient she will be excluded from the study.
• Medical indication requiring CS or other medical issues preventing upright positions in labour and birth
• Previous stillbirth or stillbirth in current pregnancy
• Inability to give informed consent.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis
The primary outcome measure is whether women mobilise or not (mean time spent upright) a two-sample T-test will be conducted to compare arms. The primary and secondary outcome measures will be assessed using descriptive and analytic statistics, odds ratios with 95% confidence intervals for categorical data, and mean +/- standard deviation, or mean and interquartile range for continuous variables. Intention to treat analysis will be undertaken.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
160
Accrual to date
51
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15746 0
Auburn Hospital & Community Health Services - Auburn
Recruitment postcode(s) [1] 29177 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 304850 0
Government body
Name [1] 304850 0
Western Sydney Local Health District (WSLHD) Research and Education (REN) Grant
Country [1] 304850 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District (WSLHD)
Address
Darcy Rd
Westmead
NSW
2145
Country
Australia
Secondary sponsor category [1] 305189 0
None
Name [1] 305189 0
Address [1] 305189 0
Country [1] 305189 0
Other collaborator category [1] 281154 0
University
Name [1] 281154 0
Western Sydney University
Address [1] 281154 0
169 Macquarie St
Parramatta
NSW
2150
Country [1] 281154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305259 0
WSLHD HREC
Ethics committee address [1] 305259 0
Ethics committee country [1] 305259 0
Australia
Date submitted for ethics approval [1] 305259 0
14/12/2018
Approval date [1] 305259 0
01/02/2019
Ethics approval number [1] 305259 0
AU RED HREC/18/WMEAD/495

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

Contacts
Principal investigator
Name 99802 0
Ms Sarah Tapp
Address 99802 0
Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144
Country 99802 0
Australia
Phone 99802 0
+61 403675666
Fax 99802 0
Email 99802 0
[email protected]
Contact person for public queries
Name 99803 0
Sarah Tapp
Address 99803 0
Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144
Country 99803 0
Australia
Phone 99803 0
+61 403675666
Fax 99803 0
Email 99803 0
[email protected]
Contact person for scientific queries
Name 99804 0
Sarah Tapp
Address 99804 0
Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144
Country 99804 0
Australia
Phone 99804 0
+61 403675666
Fax 99804 0
Email 99804 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?
De-identified individual participant data which underlies published results
When will data be available (start and end dates)?
Immediately following publication for a period of 5 years
Available to whom?
Data will be available on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
Any purpose as assessed by the principal investigator
How or where can data be obtained?
Subject to approvals by the Principal Investigator, Sarah Tapp
[email protected]
+61403 675 666


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6723Study protocol    379186-(Uploaded-04-02-2020-12-10-02)-Study-related document.docx



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.