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

Child Birth Clinical Trial

— R4B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948815
• Other study ID #: Room 4 Birth - Swe
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2020
• Source: Göteborg University
• Contact: Marie Berg, professor
• Phone: +46317866084
• Email: marie.berg[@]fhs.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1268
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Birth

Intervention

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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Chalmers University of Technology, University of Dublin, Trinity College

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 2 hours after birth