Cesarean Section Rate, Healthy, Labor Duration, Maternal Mobility
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Secondary Cesarean Section | At birth | The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Labor | 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. |
| Use of Epidural Anesthesia | During labor | Binary outcome (yes/no), recorded from medical records. |
| Use of Opioid Analgesia | During labor | Binary outcome (yes/no), recorded from hospital medication records. |
| Use of Oxytocin During Labor | During labor | Binary outcome (yes/no), recorded from clinical records. |
| Mode of Delivery | At birth | Categorized as vaginal, vaginal-operative, or cesarean section, based on hospital documentation. |
| Umbilical Artery pH Value | Immediately after birth | Value measured from cord blood sample at birth to assess fetal oxygenation. |
| APGAR Score at 10 Minutes | 10 minutes after birth | Standardized score (0-10) assessing newborn health at 10 minutes after delivery. |
| Maternal Satisfaction With Birth Experience | Within 2 hours after birth | Measured via a post-birth questionnaire completed by the participant (Likert-type scale). |
| Healthcare Professional Satisfaction | Within 2 hours after birth | Measured using a structured questionnaire completed by the attending midwife after each birth. |
| Maternal Pain Score (NRS) | During labor until immediately after birth | Numeric Rating Scale (0-10) reported by the participant to quantify perceived pain during labor. |
Countries
Switzerland