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

Not Applicable

• Conditions: Child Birth

• Registration Number: NCT03948815
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-06
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden