Birth Environment of the Future

NCT ID: NCT02478385

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-08-31

Brief Summary

The main purpose of this study is to explore the impact of the birth environment on women's birth experience and relevant birth outcomes in the experimental Labour room compared to a standard Labour room.

Detailed Description

In the last decade, there has been an increased interest in exploring the impact of the birth environment on midwifery practice and the women's birth experiences. Results from these studies show that a home-like birth environment has positive effects on both midwifery practice and the birth experience. The hormone oxytocin that causes contractions during labour may play an important role in this context. The hormone is released when being in a safe, secure and confident environment. Therefore, it is a reasonable assumption that the birth environment also has an impact on birth outcomes.

To investigate this assumption one traditional labour room was transformed to an experimental labour room. The design of the room is inspired by knowledge from evidence-based healthcare design, which describes bringing nature into the room. Furthermore, it is possible for the parents to design their own birth setting by choosing atmosphere through sound, light and nature scenes.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Birth environment labour room

Supportive care of labour room designed with special attention on sound and light effects, covering medical devices and insulation from outside noise

Group Type: ACTIVE_COMPARATOR

Supportive care in a specially designed labour room

Intervention Type: OTHER

Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards

Labour in a standard labour room

The woman gives labour in a standard labour room

Group Type: PLACEBO_COMPARATOR

Supportive care in a specially designed labour room

Intervention Type: OTHER

Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards

Interventions

Supportive care in a specially designed labour room

Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• primiparas with a singleton pregnancy
• Gestational age 37-42
• speaks and understands Danish

Exclusion Criteria

• Inducted delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herning Hospital

OTHER

Sponsor Role: lead

Responsible Party

Iben Lorentzen

Midwife, Master in Health Hummanities (MHH)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iben Lorentzen, Midwife

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology and Obstetrics at Herning, Denmark

Finn F Lauszus, MD

Role: STUDY_CHAIR

Department of Gynecology and Obstetrics at Herning, Denmark

Locations

Department of gynaecology and obstetrics, Herning Hospital

Herning, , Denmark

Countries

Denmark

References

Overgaard C, Fenger-Gron M, Sandall J. The impact of birthplace on women's birth experiences and perceptions of care. Soc Sci Med. 2012 Apr;74(7):973-81. doi: 10.1016/j.socscimed.2011.12.023. Epub 2012 Jan 28.

Reference Type: BACKGROUND

PMID: 22326105 (View on PubMed)

Foureur M, Davis D, Fenwick J, Leap N, Iedema R, Forbes I, Homer CS. The relationship between birth unit design and safe, satisfying birth: developing a hypothetical model. Midwifery. 2010 Oct;26(5):520-5. doi: 10.1016/j.midw.2010.05.015. Epub 2010 Aug 7.

Reference Type: BACKGROUND

PMID: 20692742 (View on PubMed)

Hodnett ED, Downe S, Edwards N, Walsh D. Home-like versus conventional institutional settings for birth. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD000012. doi: 10.1002/14651858.CD000012.pub2.

Reference Type: BACKGROUND

PMID: 15674867 (View on PubMed)

Lorentzen I, Andersen CS, Jensen HS, Fogsgaard A, Foureur M, Lauszus FF, Nohr EA. Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience. Contemp Clin Trials Commun. 2019 Feb 15;14:100336. doi: 10.1016/j.conctc.2019.100336. eCollection 2019 Jun.

Reference Type: DERIVED

PMID: 30886935 (View on PubMed)

Other Identifiers

fremtidensfødemiljø

Identifier Type: -

Identifier Source: org_study_id