Child BirthR4BNCT03948815
Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth
A study testing interventional birthing room in people with Child Birth, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Birth
- What is being tested?
- interventional birthing room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,268 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- induced Labour
- planned caesarean section
- multiple gestation
- lack of informed written consent
- not Speaking Swedish, Egmnlish, Arabic or Somali
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Marie Berg, professor, +46317866084, marie.berg@fhs.gu.se
About this study
Official title: Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Child Birth
- Being tested
- interventional birthing room
- Keywords
- Birthing room, labour, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional birthing roomOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention room | Experimental | An adaptable, person-centered, birthing room that is specially designed. Receives: Other: interventional birthing room |
| Control room | Other | A regular standard birthing room Receives: Other: interventional birthing room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience
Use of oxytocin for augmentation of Labour, Spontaneous vaginal birth, normal Postpartum haemorrhage, Childbirth experience
Measured: within 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child BirthStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Decreased stress, increased parasympathisuc, increased physiological oxytocin promotes a normal healthy Labour and birth.
- Masking
- None (open label)
- Enrolment
- 1,268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Chalmers University of Technology, University of Dublin, Trinity College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948815
- Sponsor's protocol ID
- Room 4 Birth - Swe
- Acronym
- R4B
- Status last verified
- Aug 2020
- First submitted
- 9 May 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37858103Berg 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.
PubMed 31744523
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03948815
- Acronym / sponsor ID
- R4B / Room 4 Birth - Swe
- Conditions
- Child Birth
- Keywords
- Birthing room, labour, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,268 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Chalmers University of Technology, University of Dublin, Trinity College
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Decreased stress, increased parasympathisuc, increased physiological oxytocin promotes a normal healthy Labour and birth.
| Arm | Type | Receives |
|---|---|---|
| Intervention room | Experimental | Other: interventional birthing roomAn adaptable, person-centered, birthing room that is specially designed. |
| Control room | Other | Other: interventional birthing roomA regular standard birthing room |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- induced Labour
- planned caesarean section
- multiple gestation
- lack of informed written consent
- not Speaking Swedish, Egmnlish, Arabic or Somali
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventional birthing roomThe 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. | Other | Control room, Intervention room |
Primary outcome
Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience
Time frame: within 2 hours after birth
Use of oxytocin for augmentation of Labour, Spontaneous vaginal birth, normal Postpartum haemorrhage, Childbirth experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 37858103Goldkuhl 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.
- Derived from this study: PubMed 31744523Berg 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.
- Individual participant dataSharing planned: No
Related trials for Child Birth
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Recruiting
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Prematurity
Active, not recruitingPhase 4
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Hepatitis B Virus - Chronic Active
RecruitingObservational study
Maternal Iron Deficiency and Childhood Health
Iron Deficiency Anaemia in Childbirth, Iron Deficiency
Recruiting
Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
Well-Being, Psychological, Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interventional birthing room in people with Child Birth, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Berg, professor (+46317866084, marie.berg@fhs.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of four variables - Use of oxytocin (Y/N); Spontaneous vaginal birth (Y/N); Normal postpartum haemorrhage (Y/N); Self-rated childbirth experience (time frame: within 2 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948815, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.