ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

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]

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]

Pharmaceutical analgesia -extracted from E-maternity (routinely collected data)

Timepoint [1]

48 hours after birth

Secondary outcome [2]

Birth Position -Extracted from E-maternity (routinely collected data)

Timepoint [2]

48 hours after birth

Secondary outcome [3]

Length of Labour (first, second and third stage) - Extracted from E-maternity (routinely collected data)

Timepoint [3]

48 hours after birth

Secondary outcome [4]

Mode of Birth - Extracted from E-maternity (routinely collected data)

Timepoint [4]

48 hours after birth

Secondary outcome [5]

Perineal Outcomes - Extracted from E-maternity (routinely collected data)

Timepoint [5]

48 hours after birth

Secondary outcome [6]

Post-partum Hemorrhage (PPH) - Extracted from E-maternity (routinely collected data)

Timepoint [6]

48 hours after birth

Secondary outcome [7]

Use of synthetic oxytocin - Extracted from E-maternity (routinely collected data)

Timepoint [7]

48 hours after birth

Secondary outcome [8]

Length of Hospital Stay - Extracted from electronic medical records (routinely collected data)

Timepoint [8]

14 days after birth

Secondary outcome [9]

Maternal Satisfaction - study specific questionnaire 'Pregnant Woman Survey"

Timepoint [9]

Within 48 hours of birth

Secondary outcome [10]

Midwifery Evaluation - study specific questionnaire "Midwifery Survey'

Timepoint [10]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Auburn Hospital & Community Health Services - Auburn

Recruitment postcode(s) [1]

2144 - Auburn

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Western Sydney Local Health District (WSLHD) Research and Education (REN) Grant

Address [1]

Darcy Rd
Westmead
NSW
2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Western Sydney University

Address [1]

169 Macquarie St
Parramatta
NSW
2150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WSLHD HREC

Ethics committee address [1]

Darcy Rd
Westmead
NSW
2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/12/2018

Approval date [1]

01/02/2019

Ethics approval number [1]

AU RED HREC/18/WMEAD/495

Summary

Brief summary

The BED Study is a pilot randomised controlled trial to investigate whether physical changes to the Birth Unit room, increase mobility and upright positioning labour. Previous studies suggest that increased mobility decreases the use of pharmacological analgesia, decreases the length of labour, decreases the caesarean section rate, improves maternal satisfaction and therefore reduces length of hospital stay 

In Auburn Hospital Birth Unit, standard room set up encourages women to immediately place themselves on the bed and stay there throughout their labour. This study will examine if a simple change to the physical set up of the room (moving the bed to the side of  room) and placing alternative birth equipment (e.g. yoga balls and birth mats) will encourage women to mobilise during labour. 

We will randomise 80 women to each arm of the study: standard birth room set up or alternate room set up without bed in central position. Data will be collected from a form that the primary midwife completes, the eMaternity database on length of labour, mobility during labour, pharmacological pain relief, caesarean section, length of hospital admissions and both the women and midwife caring for her in labour will also complete a short survey prior to discharge on the birth experience and satisfaction with the Birth Unit room.

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

N/A

Contacts

Principal investigator

Name

Ms Sarah Tapp

Address

Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144

Country

Australia

Phone

+61 403675666

Fax

sarah.tapp@health.nsw.gov.au

Contact person for public queries

Name

Sarah Tapp

Address

Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144

Country

Australia

Phone

+61 403675666

Fax

sarah.tapp@health.nsw.gov.au

Contact person for scientific queries

Name

Sarah Tapp

Address

Auburn Hospital Maternity Services
18/20 Hargrave Rd
Auburn
NSW
2144

Country

Australia

Phone

+61 403675666

Fax

sarah.tapp@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?

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
sarah.tapp@health.nsw.gov.au
+61403 675 666

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6723	Study 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.

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