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Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth (R4B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948815
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : August 6, 2020
Sponsor:
Collaborators:
Chalmers University of Technology
University of Dublin, Trinity College
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Child Birth Other: interventional birthing room Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Decreased stress, increased parasympathisuc, increased physiological oxytocin promotes a normal healthy Labour and birth.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Room 4 Birth - An Adaptable Birthing Room and the Effect on Labour and Birth: A Randomised Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
Experimental: Intervention room
An adaptable, person-centered, birthing room that is specially designed.
Other: 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.

Control room
A regular standard birthing room
Other: 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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948815


Contacts
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Contact: Marie Berg, professor +46317866084 marie.berg@fhs.gu.se
Contact: Lisa Goldkuhl, doctoral +46766186083 lisa.goldkuhl@gu.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Marie Berg, professor    +46317866084    marie.berg@fhs.gu.se   
Sponsors and Collaborators
Göteborg University
Chalmers University of Technology
University of Dublin, Trinity College
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03948815    
Other Study ID Numbers: Room 4 Birth - Swe
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Birthing room
labour
randomised controlled trial