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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 714
- 试验地点
- 2
- 主要终点
- Rate of Secondary Cesarean Section
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of Secondary Cesarean Section
时间窗: At birth
The proportion of women who undergo a cesarean section after the onset of labor (i.e. unplanned cesarean section).
次要结局
- Mode of Delivery(At birth)
- APGAR Score at 10 Minutes(10 minutes after birth)
- Duration of Labor(From clinical onset of first stage of labor (regular contractions with cervical dilation > 3-4cm) until birth.)
- Use of Epidural Anesthesia(During labor)
- Maternal Pain Score (NRS)(During labor until immediately after birth)
- Use of Opioid Analgesia(During labor)
- Maternal Satisfaction With Birth Experience(Within 2 hours after birth)
- Healthcare Professional Satisfaction(Within 2 hours after birth)
- Use of Oxytocin During Labor(During labor)
- Umbilical Artery pH Value(Immediately after birth)