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Birth Environment of the Future

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ClinicalTrials.gov Identifier: NCT02478385
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Iben Lorentzen, Herning Hospital

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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Supportive care in a specially designed labour room Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Birth Environment of the Future - a Randomised Controlled Study
Study Start Date : May 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 2018

Arm Intervention/treatment
Active Comparator: 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
Other: 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

Placebo Comparator: Labour in a standard labour room
The woman gives labour in a standard labour room
Other: 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




Primary Outcome Measures :
  1. No. of women receiving oxytocin stimulation during Labour [ Time Frame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes ]
    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


Secondary Outcome Measures :
  1. Duration of labour [ Time Frame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes ]
    Minutes of stay in labour room until delivery is registered in separate data sheet with time of arrival and time of delivery

  2. Pain relieving interventions [ Time Frame: From allocation at delivery ward (date, hour and minute) to delivery (date, hour, minute). Duration is recorded time in hours and minutes ]
    Interventions with epidural and pudendal analgesia are registered in the electronic patient journal


Other Outcome Measures:
  1. Evaluation of woman-centred care during labour and childbirth [ Time Frame: Six weeks after delivery a questionaire is e-mailed to the women ]
    Woman-centred care during labour and childbirth questionnaire

  2. Paternal evaluation of the labour room environment [ Time Frame: Two weeks after delivery a questionnaire is e-mailed to the father ]
    Questionaire in process of making



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inducted delivery

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): NCT02478385


Locations
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Denmark
Department of gynaecology and obstetrics, Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
Investigators
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Principal Investigator: Iben Lorentzen, Midwife Department of Gynecology and Obstetrics at Herning, Denmark
Study Chair: Finn F Lauszus, MD Department of Gynecology and Obstetrics at Herning, Denmark

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iben Lorentzen, Midwife, Master in Health Hummanities (MHH), Herning Hospital
ClinicalTrials.gov Identifier: NCT02478385     History of Changes
Other Study ID Numbers: fremtidensfødemiljø
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Iben Lorentzen, Herning Hospital:
Birth environment
oxytocin
epidural
analgesia
home-like