NCT07052331

The MOBY Study: Efficacy of Birth Mobility

The MOBY Study - Efficacy of Birth Mobility: Randomized Clinical Trial Investigating the Efficacy of Birth Mobility on Birth Outcomes in Primiparous Women With and Without a Birth Mobility System.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 714 (estimated)
• Sponsor: Vibwife AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Labor Duration
• Cesarean Section Rate
• Maternal Mobility
• Healthy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-07-25
• Primary completion: 2028-07-01
• Completion: 2028-08-01
• First posted: 2025-07-04
• Last updated: 2025-12-23

Locations

1 site across 1 country: Switzerland