Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT02332759
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 effects elasticity of tissue such as scleroderma or lupus
* Local or systemic infection e.g. HIV, herpes
* Diabetes
* Clinically estimated fetal weight \> 4,500 grams
* Any prior surgical procedures to the vaginal anatomy which 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
* A cervical dilation of greater than or equal to 6 cm
* BMI \> 32.5 prior to becoming pregnant
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02332759
Study Brief:
Protocol Section:
NCT02332759