Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
714 participants
INTERVENTIONAL
2025-07-25
2028-08-31
Brief Summary
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Detailed Description
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The aim of the study is to examine whether certain positions and mobility during labor can positively influence the birth process. These insights may improve support for women in labor in the future.
Participants are randomly assigned to one of two groups:
The control group receives the usual hospital infrastructure, including a conventional static birthing bed.
The intervention group receives, in addition to standard care, access to a CE-marked birth mobility system that offers supportive movement options. Participants in this group are shown a short instructional video.
In both groups, positioning and movement during labor are recorded passively using a non-intrusive monitoring setup. These recordings are not noticeable for the participants and do not interfere with clinical care. The medical team continues to provide position recommendations according to each individual situation and based on current standards in midwifery and obstetrics. Women are always free to move and position themselves as they wish.
After birth, participants are asked to complete a short questionnaire about their birth experience. A similar questionnaire is completed by the midwife.
The primary objective is to determine whether the use of the birth mobility system is associated with a lower rate of secondary cesarean sections. Secondary objectives include analysis of labor duration, analgesia and oxytocin use, pain levels, birth mode, neonatal outcomes, and satisfaction of participants and healthcare providers. In addition, movement characteristics observed during labor will be explored to support future research and care improvements.
This is a Category A1 study involving CE-marked medical devices used according to their intended purpose. The study follows ISO 14155, the current version of the Declaration of Helsinki, ICH-GCP, and all legally applicable national regulations. The study has been approved by the responsible Ethics Committee (EKNZ). All personal data are pseudonymized and handled in compliance with Swiss and international data protection standards. No risks beyond standard obstetric care are introduced by participation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Birth Mobility System
Participants receive standard obstetric care and have access to a birth mobility system installed on the birthing bed. Use of the system is voluntary and guided by medical professionals. Participants view a video explaining the system's operation. Birth mobility data is collected passively.
Birth Mobility System
Participants receive standard obstetric care and have access to a birth mobility system installed on the birthing bed. Use of the system is voluntary and guided by medical professionals. Participants view a video explaining the system's operation. Birth mobility data is collected passively.
Standard obstetric care
Participants receive standard obstetric care using a conventional birthing bed. No access is given to the birth mobility system. Birth mobility data is collected passively.
No interventions assigned to this group
Interventions
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Birth Mobility System
Participants receive standard obstetric care and have access to a birth mobility system installed on the birthing bed. Use of the system is voluntary and guided by medical professionals. Participants view a video explaining the system's operation. Birth mobility data is collected passively.
Eligibility Criteria
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Inclusion Criteria
* German- or English-speaking
* Able to provide written informed consent with capacity of judgment
* Low-risk singleton pregnancy
* Primiparous woman
* Cephalic presentation
* Gestational age at delivery ≥ 37 + 0 weeks
Exclusion Criteria
* Not capable of understanding instructions for use of the mobility system (intervention group)
* Scheduled (elective) cesarean section
* Contraindication to vaginal delivery
* Multiple pregnancy
* Breech presentation
* Estimated fetal weight \< 10th percentile or \> 90th percentile
* Relevant fetal congenital abnormalities affecting neonatal adaptation
* Pre-existing medical conditions significantly affecting mobility (e.g., orthopedic conditions, osteoporosis, multiple sclerosis, spinal cord injury)
* Relevant intrapartum bleeding
* Preeclampsia or HELLP syndrome
18 Years
FEMALE
No
Sponsors
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Kantonsspital Baden
OTHER
Fachhochschule Nordwestschweiz
OTHER
Vibwife AG
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. med. Leonhard Schäffer
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Baden
Locations
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Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Prof. Dr. med. Leonhard Schäffer
Role: primary
References
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Romano AM, Lothian JA. Promoting, protecting, and supporting normal birth: a look at the evidence. J Obstet Gynecol Neonatal Nurs. 2008 Jan-Feb;37(1):94-104; quiz 104-5. doi: 10.1111/j.1552-6909.2007.00210.x.
Hanson L. Second-stage labor care: challenges in spontaneous bearing down. J Perinat Neonatal Nurs. 2009 Jan-Mar;23(1):31-9; quiz 40-1. doi: 10.1097/JPN.0b013e318196526b.
Opiyo N, Kingdon C, Oladapo OT, Souza JP, Vogel JP, Bonet M, Bucagu M, Portela A, McConville F, Downe S, Gulmezoglu AM, Betran AP. Non-clinical interventions to reduce unnecessary caesarean sections: WHO recommendations. Bull World Health Organ. 2020 Jan 1;98(1):66-68. doi: 10.2471/BLT.19.236729. Epub 2019 Nov 29. No abstract available.
Monod C, Granado C, Mueller D, Gisin M, Ries JJ, Horn S, Erlanger TE, Hoesli I. Safety and acceptance of "Vibwife", a new moving mattress to support mobilization during labor: Result of a clinical study. Midwifery. 2021 Dec;103:103096. doi: 10.1016/j.midw.2021.103096. Epub 2021 Jul 17.
Ondeck M. Healthy birth practice #2: walk, move around, and change positions throughout labor. J Perinat Educ. 2014 Fall;23(4):188-93. doi: 10.1891/1058-1243.23.4.188.
Roberts J, Hanson L. Best practices in second stage labor care: maternal bearing down and positioning. J Midwifery Womens Health. 2007 May-Jun;52(3):238-45. doi: 10.1016/j.jmwh.2006.12.011.
Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Aug 20;(8):CD003934. doi: 10.1002/14651858.CD003934.pub3.
Other Identifiers
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103.215 IP-LS
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2025-D0016
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-D0016
Identifier Type: -
Identifier Source: org_study_id