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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07052331
Acronym
MOBY
Enrollment
714
Registered
2025-07-04
Start date
2025-07-25
Completion date
2028-08-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Rate, Healthy, Labor Duration, Maternal Mobility

Keywords

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

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.

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.

Interventions

DEVICEBirth 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.

Sponsors

Kantonsspital Baden
CollaboratorOTHER
Fachhochschule Nordwestschweiz
CollaboratorOTHER
Vibwife AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Secondary Cesarean SectionAt birthThe proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section).

Secondary

MeasureTime frameDescription
Duration of LaborFrom clinical onset of first stage of labor (regular contractions with cervical dilation > 3-4cm) until birth.Measured separately for the first and second stages of labor in minutes.
Use of Epidural AnesthesiaDuring laborBinary outcome (yes/no), recorded from medical records.
Use of Opioid AnalgesiaDuring laborBinary outcome (yes/no), recorded from hospital medication records.
Use of Oxytocin During LaborDuring laborBinary outcome (yes/no), recorded from clinical records.
Mode of DeliveryAt birthCategorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation.
Umbilical Artery pH ValueImmediately after birthValue measured from cord blood sample at birth to assess fetal oxygenation.
APGAR Score at 10 Minutes10 minutes after birthStandardized score (0-10) assessing newborn health at 10 minutes after delivery.
Maternal Satisfaction With Birth ExperienceWithin 2 hours after birthMeasured via a post-birth questionnaire completed by the participant (Likert-type scale).
Healthcare Professional SatisfactionWithin 2 hours after birthMeasured using a structured questionnaire completed by the attending midwife after each birth.
Maternal Pain Score (NRS)During labor until immediately after birthNumeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor.

Countries

Switzerland

Contacts

Primary ContactProf. Dr. med. Leonhard Schäffer
leonhard.schaeffer@ksb.ch+41 56 486 35 07

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026