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

NCT ID: NCT03948815

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Child Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention room

An adaptable, person-centered, birthing room that is specially designed.

Group Type EXPERIMENTAL

interventional birthing room

Intervention Type OTHER

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.

Control room

A regular standard birthing room

Group Type OTHER

interventional birthing room

Intervention Type OTHER

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.

Interventions

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interventional 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chalmers University of Technology

OTHER

Sponsor Role collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Marie Berg, professor

Role: CONTACT

+46317866084

Lisa Goldkuhl, doctoral

Role: CONTACT

+46766186083

Facility Contacts

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Marie Berg, professor

Role: primary

+46317866084

References

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Goldkuhl L, Tistad M, Gyllensten H, Berg M. Implementing a new birthing room design: a qualitative study with a care provider perspective. BMC Health Serv Res. 2023 Oct 19;23(1):1122. doi: 10.1186/s12913-023-10051-3.

Reference Type DERIVED
PMID: 37858103 (View on PubMed)

Berg M, Goldkuhl L, Nilsson C, Wijk H, Gyllensten H, Lindahl G, Uvnas Moberg K, Begley C. Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden. Trials. 2019 Nov 19;20(1):629. doi: 10.1186/s13063-019-3765-x.

Reference Type DERIVED
PMID: 31744523 (View on PubMed)

Other Identifiers

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Room 4 Birth - Swe

Identifier Type: -

Identifier Source: org_study_id

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