A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 44
- 主要终点
- The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
研究概览
简要总结
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device
Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor.
Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.
详细描述
Vaginal delivery is a major risk factor for pelvic floor dysfunction. Clinical aspects of pelvic floor dysfunction include pelvic organ prolapse, sexual dysfunction, and fecal and urinary incontinence. Trauma to the pelvic structures occurs as the fetal head passes through the vaginal canal, especially with acute distension at the time of crowning - the exiting of the fetal head.
The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor in order to prepare the vaginal canal for vaginal delivery. By slowly pre-stretching the vagina and surrounding pelvic tissues during labor, the device is essentially dictating the strain rate of the tissue during labor. In previous feasibility studies, the elastic recovery of the tissue has been shown to be on the order of several hours, allowing the benefits of pre-stretching the vagina and surrounding pelvic tissues to last throughout labor. The device is intended to be removed prior to the initiation of the second stage of labor, for delivery to occur unobstructed.
The target patient population for this study is nulliparous women entering the first phase of labor and scheduled for vaginal delivery with an epidural.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The physician reading all ultrasound images will be blinded to randomization
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
- •Criteria for inclusion
- •Subject is scheduled for vaginal birth.
- •Subject is gestating a single fetus.
- •Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
- •Subject is able and willing to comply with the protocol required follow-up visits.
- •Subject is able and willing to provide written informed consent prior to enrollment.
- •In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience with the device.
- •Subject receives epidural anesthesia during labor prior to enrollment.
- •Subject is 18 years of age or older at time of consent.
排除标准
- •Criteria for exclusion
- •Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
- •Subject is planning or requires a Caesarean-section prior to randomization.
- •Subject begins labor with less than 36 weeks gestation.
- •Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
- •Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
- •Subject has a localized (genital tract) or systemic infection.
- •Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
- •Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
- •Subject has placenta previa or vasa previa.
- •Subject has known significant chromosomal or structural fetal anomalies.
- •Subject has a category 2 and/or 3 fetal tracing that is unresolved.
- •Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.
研究组 & 干预措施
Materna Prep Device
Materna Prep Device
干预措施: Materna Prep Device (Device)
Standard of Care (SOC)
Standard of Care (SOC)
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
时间窗: 12-month Follow-up
Use transperineal ultrasound to identify levator ani muscle detachment
次要结局
- The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging(12-Month Follow-up)
- Length of 2nd Stage Labor(Intra-Procedure)
- Perineal Lacerations(Intra-Procedure)
- C-Sections(Intra-Procedure)
- User Satifaction(Intra-Procedure)
- Levator Hiatal Area(3-month and 12-month Follow-up)
- Obstetric anal sphincter injury - OASI(3-month follow-up)
- Qualitative pain(3-Month and12-month Follow-up)
- Types of Perineal Lacerations(Intra-Procedure)
- First Push to Delivery(Intra-Procedure)
- Operative Delivery(Intra-Procedure)
- Infant APGAR scores(Intra-Procedure)
- Reasons for C-Sections(Intra-Procedure)
- Qualitative pelvic health feedback(3-Month and 12-month Follow-up)