NCT02478385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started May 2015

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

March 17, 2015

Last Update Submit

February 25, 2019

Conditions

Pregnancy

Keywords

Birth environmentoxytocinepiduralanalgesiahome-like

Outcome Measures

Primary Outcomes (1)

  • No. of women receiving oxytocin stimulation during Labour

    No of women augmented with oxytocin drip. The intervention is registered in the electronic patient journal. The duration in time (date,hours,minutes) of oxytocin treatment is registered in the electronic journal log

    From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes

Secondary Outcomes (2)

  • Duration of labour

    From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes

  • Pain relieving interventions

    From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes

Other Outcomes (2)

  • Evaluation of woman-centred care during labour and childbirth

    Six weeks after delivery a questionaire is e-mailed to the women

  • Paternal evaluation of the labour room environment

    Two weeks after delivery a questionnaire is e-mailed to the father

Study Arms (2)

Birth environment labour room

ACTIVE COMPARATOR

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

Other: Supportive care in a specially designed labour room

Labour in a standard labour room

PLACEBO COMPARATOR

The woman gives labour in a standard labour room

Other: Supportive care in a specially designed labour room

Interventions

Supportive care in a specially designed labour roomOTHER

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

Birth environment labour roomLabour in a standard labour room

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inducted delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of gynaecology and obstetrics, Herning Hospital

Herning, 7400, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 22326105BACKGROUND

  • 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.

    PMID: 20692742BACKGROUND

  • 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.

    PMID: 15674867BACKGROUND

  • 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.

    PMID: 30886935DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Iben Lorentzen, Midwife

    Department of Gynecology and Obstetrics at Herning, Denmark

    PRINCIPAL INVESTIGATOR

  • Finn F Lauszus, MD

    Department of Gynecology and Obstetrics at Herning, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife, Master in Health Hummanities (MHH)

Study Record Dates

First Submitted

March 17, 2015

First Posted

June 23, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

DK(1)