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NCT Number: NCT07052331

The MOBY Study: Efficacy of Birth Mobility

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location status: Recruiting

Location contact

Prof. Dr. med. Leonhard Schäffer

CONTACT

[email protected]

+41 56 486 35 07

Prof. Dr. med. Leonhard Schäffer

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of Secondary Cesarean Section

    Time frame: At birth

    The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section).

Secondary outcomes

  1. Mode of Delivery

    Time frame: At birth

    Categorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation.

  2. Duration of Labor

    Time frame: From 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.

  3. Use of Epidural Anesthesia

    Time frame: During labor

    Binary outcome (yes/no), recorded from medical records.

  4. Use of Opioid Analgesia

    Time frame: During labor

    Binary outcome (yes/no), recorded from hospital medication records.

  5. Use of Oxytocin During Labor

    Time frame: During labor

    Binary outcome (yes/no), recorded from clinical records.

  6. Maternal Pain Score (NRS)

    Time frame: During labor until immediately after birth

    Numeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor.

  7. Umbilical Artery pH Value

    Time frame: Immediately after birth

    Value measured from cord blood sample at birth to assess fetal oxygenation.

  8. APGAR Score at 10 Minutes

    Time frame: 10 minutes after birth

    Standardized score (0-10) assessing newborn health at 10 minutes after delivery.

  9. Maternal Satisfaction With Birth Experience

    Time frame: Within 2 hours after birth

    Measured via a post-birth questionnaire completed by the participant (Likert-type scale).

  10. Healthcare Professional Satisfaction

    Time frame: Within 2 hours after birth

    Measured using a structured questionnaire completed by the attending midwife after each birth.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. med. Leonhard Schäffer

CONTACT

[email protected]

+41 56 486 35 07

Sponsors and collaborators

Lead sponsor

Vibwife AG

Industry

Collaborators

  • Fachhochschule Nordwestschweiz
  • Kantonsspital Baden

Registry information

Official study title

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.

Acronym: MOBY

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 4, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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