EASE: The Materna Prep Pivotal Study

Inclusion Criteria:

Criteria for inclusion

1. Subject is scheduled for vaginal birth.

2. Subject is gestating a single fetus.

3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeksgestation.

4. Subject is able and willing to comply with the protocol required follow-up visits.

5. Subject is able and willing to provide written informed consent prior to enrollment.

6. In the opinion of the Investigator, the subject has sufficient mental capacity tounderstand the informed consent form (ICF), comply with the protocol requirements,and provide clinically relevant and reliable feedback regarding their experiencewith the device.

7. Subject receives epidural anesthesia during labor prior to enrollment.

8. Subject is 18 years of age or older at time of consent.

Exclusion Criteria:

Criteria for exclusion

1. Subject has high likelihood of less than 1 hour of potential device dilation timeafter she arrives at the hospital.

2. Subject is planning or requires a Caesarean-section prior to randomization.

3. Subject begins labor with less than 36 weeks gestation.

4. Subject has a neurological disorder that could cause pelvic floor dysfunction, suchas multiple sclerosis or spinal cord injury.

5. Subject has a collagen-associated disorder that affects tissue elasticity, such asscleroderma or Ehlers-Danlos syndrome.

6. Subject has a localized (genital tract) or systemic infection.

7. Subject has a medical history which could lead to pelvic floor dysfunction, such asprior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.

8. Subject has any general health condition or systemic disease that may represent, inthe opinion of the Investigator, a potential increased risk associated with deviceuse or pregnancy.

9. Subject has placenta previa or vasa previa.

10. Subject has known significant chromosomal or structural fetal anomalies.

11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.

12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissueduring the course of labor.