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Birth Environment Design Study for Pregnant Women

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000238976
Acronym
BED Study
Enrollment
51
Registered
2020-02-25
Start date
2019-04-16
Completion date
2020-12-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 co

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.

Sponsors

Western Sydney Local Health District (WSLHD)
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026