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| ID | Type | Description | Link |
|---|---|---|---|
| 103.215 IP-LS | Other Grant/Funding Number | INNOSUISSE | |
| 2025-D0016 | Registry Identifier | Swiss National Clinical Trials Portal (SNCTP) |
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| Name | Class |
|---|---|
| Kantonsspital Baden | OTHER |
| Fachhochschule Nordwestschweiz | OTHER |
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This randomized clinical trial investigates whether and how maternal mobility during labor influences birth outcomes in primiparous women. The study compares standard obstetric care with care that includes a birth mobility system. The primary aim is to assess whether the system helps reduce secondary cesarean section rates. Secondary objectives include evaluation of labor progression, medication use, newborn health, and user satisfaction. Participation occurs during birth and includes the collection of routine clinical data and a short questionnaire afterward.
The MOBY study is a randomized clinical investigation evaluating the efficacy of maternal birth mobility on delivery outcomes in first-time mothers. The study takes place at Kantonsspital Baden and includes 714 participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Birth Mobility System | Experimental | 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. |
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| Standard obstetric care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Birth Mobility System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Secondary Cesarean Section | The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section). | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of Delivery | Categorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation. | At birth |
| Duration of Labor | Measured separately for the first and second stages of labor in minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Leonhard Schäffer | Contact | +41 56 486 35 07 | leonhard.schaeffer@ksb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. med. Leonhard Schäffer | Kantonsspital Baden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Recruiting | Baden | Canton of Aargau | 5404 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31902964 | Background | 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. | |
| 18226163 |
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Individual participant data (IPD) will not be shared in order to fully protect participant privacy. Although the data are pseudonymized, elements such as birth date and detailed clinical information in a single-site population may still carry a risk of re-identification. In accordance with Swiss data protection law and ethics approval conditions, only aggregated and anonymized results will be published.
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| From clinical onset of first stage of labor (regular contractions with cervical dilation > 3-4cm) until birth. |
| Use of Epidural Anesthesia | Binary outcome (yes/no), recorded from medical records. | During labor |
| Use of Opioid Analgesia | Binary outcome (yes/no), recorded from hospital medication records. | During labor |
| Use of Oxytocin During Labor | Binary outcome (yes/no), recorded from clinical records. | During labor |
| Maternal Pain Score (NRS) | Numeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor. | During labor until immediately after birth |
| Umbilical Artery pH Value | Value measured from cord blood sample at birth to assess fetal oxygenation. | Immediately after birth |
| APGAR Score at 10 Minutes | Standardized score (0-10) assessing newborn health at 10 minutes after delivery. | 10 minutes after birth |
| Maternal Satisfaction With Birth Experience | Measured via a post-birth questionnaire completed by the participant (Likert-type scale). | Within 2 hours after birth |
| Healthcare Professional Satisfaction | Measured using a structured questionnaire completed by the attending midwife after each birth. | Within 2 hours after birth |
| 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. |
| 19209057 | Background | 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. |
| 34311336 | Background | 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. |
| 25411538 | Background | 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. |
| 17467590 | Background | 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. |
| 23959763 | Background | 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. |