Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-009271
NCT ID: NCT03973281
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
Vaginal delivery is a major risk factor 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.
Currently, there is no standardized approach for preparing the vagina for delivery to avoid trauma and injury to the pelvic floor. There are myriad perineal techniques which can be employed to slow down the birth of the baby’s head and allow the perineum to stretch slowly to prevent injury. Perineal massage, passive descent, hot compresses, and “hands-on” delivery are the most common forms of intervention used to prepare the vagina for delivery however, there is significant variability in the methods, timing, and applied forces.
Studies that have shown that perineal massage reduces the injury rate of tissue are due to stretching the tissue more, over a greater length of time. In a critical review and meta-analysis of the literature, perineal massage performed by introducing the middle and index fingers into the vagina to gently stretch the perineum from side to side, reduces the risk of severe injury to the perineum and pelvic muscles in nulliparous women.
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject scheduled for vaginal birth.
- Subject gestating a single fetus.
- Subject nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
- Subject able and willing to comply with the protocol required follow-up visits.
- Subjects 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 using the device.
- Subject 18 years of age or older at time of consent.
Exclusion Criteria:
- 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 prior surgical procedures to the vaginal anatomy which could lead to pelvic floor dysfunction, such as pelvic fractures or pelvic soft tissue injuries.
- 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.
Eligibility last updated 5/22/23. Questions regarding updates should be directed to the study team contact.