Labor DurationMOBYNCT07052331
The MOBY Study: Efficacy of Birth Mobility
A study testing Birth Mobility System in people with Labor Duration and Cesarean Section Rate, run by Vibwife AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Duration, Cesarean Section Rate, Maternal Mobility
- What is being tested?
- Birth Mobility System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jul 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5404
Prof. Dr. med. Leonhard Schäffer, +41 56 486 35 07, leonhard.schaeffer@ksb.ch
Prof. Dr. med. Leonhard Schäffer
About this study
Official 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.
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.
Read the 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
- Being tested
- Birth Mobility System
- Keywords
- Birth mobility, Maternal satisfaction, Labor and delivery, Neonatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth Mobility SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Secondary Cesarean Section
The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section).
Measured: At birth
Secondary outcomes (10)
Mode of Delivery
Categorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation.
Measured: At birth
Duration of Labor
Measured separately for the first and second stages of labor in minutes.
Measured: 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.
Measured: During labor
Use of Opioid Analgesia
Binary outcome (yes/no), recorded from hospital medication records.
Measured: During labor
Use of Oxytocin During Labor
Binary outcome (yes/no), recorded from clinical records.
Measured: During labor
Maternal Pain Score (NRS)
Numeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor.
Measured: During labor until immediately after birth
Umbilical Artery pH Value
Value measured from cord blood sample at birth to assess fetal oxygenation.
Measured: Immediately after birth
APGAR Score at 10 Minutes
Standardized score (0-10) assessing newborn health at 10 minutes after delivery.
Measured: 10 minutes after birth
Maternal Satisfaction With Birth Experience
Measured via a post-birth questionnaire completed by the participant (Likert-type scale).
Measured: Within 2 hours after birth
Healthcare Professional Satisfaction
Measured using a structured questionnaire completed by the attending midwife after each birth.
Measured: Within 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start25 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Labor DurationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vibwife AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kantonsspital Baden, Fachhochschule Nordwestschweiz
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Leonhard Schäffer, Principal investigator, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052331
- Sponsor's protocol ID
- 2025-D0016
- Other IDs
- 103.215 IP-LS, 2025-D0016
- Acronym
- MOBY
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31902964Romano 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.
PubMed 18226163Hanson 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.
PubMed 19209057Monod 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.
PubMed 34311336Ondeck 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.
PubMed 25411538Roberts 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.
PubMed 17467590Lawrence 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.
PubMed 23959763
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07052331
- Acronym / sponsor ID
- MOBY / 2025-D0016
- Conditions
- Labor Duration, Cesarean Section Rate, Maternal Mobility, Healthy
- Keywords
- Birth mobility, Maternal satisfaction, Labor and delivery, Neonatal outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- Vibwife AGIndustry (pharma, biotech, devices)
- Collaborators
- Kantonsspital Baden, Fachhochschule Nordwestschweiz
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth Mobility System | Experimental | Device: Birth Mobility SystemParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- German- or English-speaking
- Able to provide written informed consent with capacity of judgment
- Low-risk singleton pregnancy
- Primiparous woman
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth Mobility SystemParticipants 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 |
Primary outcome
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).
10 secondary outcomes
Mode of Delivery
Time frame: At birth
Duration of Labor
Time frame: From clinical onset of first stage of labor (regular contractions with cervical dilation > 3-4cm) until birth.
Use of Epidural Anesthesia
Time frame: During labor
Use of Opioid Analgesia
Time frame: During labor
Use of Oxytocin During Labor
Time frame: During labor
Maternal Pain Score (NRS)
Time frame: During labor until immediately after birth
Umbilical Artery pH Value
Time frame: Immediately after birth
APGAR Score at 10 Minutes
Time frame: 10 minutes after birth
Maternal Satisfaction With Birth Experience
Time frame: Within 2 hours after birth
Healthcare Professional Satisfaction
Time frame: Within 2 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 31902964Opiyo 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.
- Background: PubMed 18226163Romano 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.
- Background: PubMed 19209057Hanson 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.
- Background: PubMed 34311336Monod 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.
- Background: PubMed 25411538Ondeck 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.
- Background: PubMed 17467590Roberts 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.
- Background: PubMed 23959763Lawrence 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. med. Leonhard Schäffer principal investigator
Kantonsspital Baden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth Mobility System in people with Labor Duration and Cesarean Section Rate, run by Vibwife AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. Leonhard Schäffer (+41 56 486 35 07, leonhard.schaeffer@ksb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Secondary Cesarean Section (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052331, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.