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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03190434
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and 45 years.
* Subject minimum 16 weeks of pregnancy.
* Who will sign the informed consent form.
* Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling undetermined whether this is amniotic fluid leakage or urinary incontinence).
Exclusion Criteria:
* Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimester.
* Subjects that have had sexual relations within the last 12 hours.
* Subject is unable or unwilling to cooperate with study procedures.
* Subject used the AL-SENSE before joining this study.
* Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.
* Subject using vaginal products such as some douching formulas, some antibiotic treatments which reduce lactobacillus population.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03190434
Study Brief:
Protocol Section:
NCT03190434