The MOBY Study: Efficacy of Birth Mobility

NCT07052331 | Recruiting DMC

• 2 other identifiers: 2025-D0016103.215 IP-LS
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section Rate; Healthy; Labor Duration; Maternal Mobility

Keywords

Birth mobility; Maternal satisfaction; Labor and delivery; Neonatal outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Mode of Delivery

  At birth

• Duration of Labor

  From clinical onset of first stage of labor (regular contractions with cervical dilation > 3-4cm) until birth.

• Use of Epidural Anesthesia

  During labor

• Use of Opioid Analgesia

  During labor

• Use of Oxytocin During Labor

  During labor

Study Arms (2)

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.

Device: Birth Mobility System

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.

Interventions

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.

Birth Mobility System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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

You may not qualify if:

• Multiparous woman
• 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

Sponsors & Collaborators

• Vibwife AG: lead
• Kantonsspital Baden: collaborator
• Fachhochschule Nordwestschweiz: collaborator

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

RECRUITING

Related Publications (7)

• 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.

  PMID: 31902964 BACKGROUND

• 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.

  PMID: 18226163 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.

  PMID: 19209057 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.

  PMID: 34311336 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.

  PMID: 25411538 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.

  PMID: 17467590 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.

  PMID: 23959763 BACKGROUND

Study Officials

• Prof. Dr. med. Leonhard Schäffer

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. med. Leonhard Schäffer

CONTACT

+41 56 486 35 07; leonhard.schaeffer@ksb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)