A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. The device will be used during the first stage of labor, following initiation of epidural anesthesia and after the cervix has dilated to between 3-8 cm. Up to 20 subjects will be included in the initial study, with the option to increase the number of subjects to 50 based on early data.
详细描述
Study Inclusion Criteria are:
- Patients attending for antenatal care at El Camino Hospital with the Altos Oaks Obstetrics Group
- First ongoing pregnancy beyond 20 weeks
- Singleton, cephalic presentation
- No pregnancy complications which are likely to require Caesarean Section
- Planned vaginal delivery
The primary outcome measure is device safety as defined by freedom of device related adverse events. Secondary efficacy outcome measures are:
- Pelvic muscle damage as determined by ultrasound imaging
- Length of the 2nd stage of labour
- Delivery mode
- Perineal and anal sphincter trauma
- Symptoms of incontinence, prolapse and sexual dysfunction 2 years postpartum
- Pelvic organ support (ICS POP-Q system) and pelvic organ descent on ultrasound
Interested patients will have the study presented to them during their pre-natal visits with the Altos Oaks Obstetrics group. Interested patients will have the study explained to them and will be given the Informed Consent document.After the informed consent procedure, patients will undergo an interview and 4D translabial ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Primiparas, or previous pregnancy terminated before 24 weeks gestation
- •Single fetus birth
- •Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent.
- •Subject is willing and able to comply with specified follow-up evaluations.
- •Planned to have epidural during birthing process
排除标准
- •Previous delivery, or previous pregnancy beyond 24 weeks gestation
- •Less than 36 weeks gestation
- •Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders
- •Muscular or skin disorder that affects elasticity of tissue such as scleroderma or lupus.
- •Local or systemic infection e.g. HIV, herpes
- •Any prior surgical procedures to the vaginal anatomy that could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. Evaluated during baseline screening
- •High likelihood of less than 1 hour of potential device dilation time after the woman arrives at the center and receives epidural
结局指标
主要结局
Safety
时间窗: 3 months post-delivery follow-up
Freedom from device related adverse events
次要结局
- Pelvic Muscle Avulsion(1-3 months post delivery)
- Pelvic Muscle Damage(1-3 Months Post-Delivery)
- Delivery Time(Immediate after delivery)
- Perineal Lacerations(Immediate Post Delivery)
- Instrument Deliveries(Immediate Post-Delivery)