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Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth

Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03948815
Acronym
R4B
Enrollment
1268
Registered
2019-05-14
Start date
2019-01-01
Completion date
2023-12-31
Last updated
2020-08-06

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

Conditions

Child Birth

Keywords

Birthing room, labour, randomised controlled trial

Brief summary

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This study will measure and compare effects and experiences of two types of birthing rooms.

Detailed description

Healthcare Environment influences health outcomes. The effects of physical aspects of the birthing room on maternal and neonatal outcomes is insufficiently studied. This RCT project measures and compares effects and experiences of two types of birthing rooms at one Labour ward in Sweden. A qualitative ethnografic studu will assess how women interact with the birthing rooms and its physical objects.

Interventions

OTHERinterventional birthing room

The design of the room is based on scientific evidence on the healthcare environment in general, and on a systematic review on the effect of birthing rooms published by the investigators, and interviews with women early after birth in Sweden. The room has a large birthing pool, several lighting options with dimming function, 40 mm suspended sound absorber in the ceiling, media installation covering two walls, which offers a choice of six different programmed nature scenes with light, sound effect and Music.

Sponsors

Chalmers University of Technology
CollaboratorOTHER
University of Dublin, Trinity College
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Decreased stress, increased parasympathisuc, increased physiological oxytocin promotes a normal healthy Labour and birth.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* pregnant women * Robson 1 classified, i.e. nulliparous, single Pregnancy \>37 weeks, cephalic presentation, sponatanous Labour start * speak, understand Swedish, English, arabic or somali or have an interpreter present * Active phase of Labour: 2 of these 3 criteria fulfilled: sponatanous rupture of membranes, 2-3 painful contractions in 10 minutes; cervix dilated \>3-4 cm or effaced and open \>1cm

Exclusion criteria

* induced Labour * planned caesarean section * multiple gestation * lack of informed written consent * not Speaking Swedish, Egmnlish, Arabic or Somali

Design outcomes

Primary

MeasureTime frameDescription
Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experiencewithin 2 hours after birthUse of oxytocin for augmentation of Labour, Spontaneous vaginal birth, normal Postpartum haemorrhage, Childbirth experience

Countries

Sweden

Contacts

Primary ContactMarie Berg, professor
marie.berg@fhs.gu.se+46317866084
Backup ContactLisa Goldkuhl, doctoral
lisa.goldkuhl@gu.se+46766186083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026