Kantonsspital Baden
Baden, Canton of Aargau, 5404, Switzerland
Location status: Recruiting
Location contact
Prof. Dr. med. Leonhard Schäffer
CONTACT
Prof. Dr. med. Leonhard Schäffer
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07052331
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Baden, Canton of Aargau, 5404, Switzerland
Location status: Recruiting
Prof. Dr. med. Leonhard Schäffer
CONTACT
Prof. Dr. med. Leonhard Schäffer
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At birth
The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section).
Time frame: At birth
Categorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation.
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.
Time frame: During labor
Binary outcome (yes/no), recorded from medical records.
Time frame: During labor
Binary outcome (yes/no), recorded from hospital medication records.
Time frame: During labor
Binary outcome (yes/no), recorded from clinical records.
Time frame: During labor until immediately after birth
Numeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor.
Time frame: Immediately after birth
Value measured from cord blood sample at birth to assess fetal oxygenation.
Time frame: 10 minutes after birth
Standardized score (0-10) assessing newborn health at 10 minutes after delivery.
Time frame: Within 2 hours after birth
Measured via a post-birth questionnaire completed by the participant (Likert-type scale).
Time frame: Within 2 hours after birth
Measured using a structured questionnaire completed by the attending midwife after each birth.
Contact information is provided by the study sponsor or research team.
Vibwife AG
Industry
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
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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