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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT03177135
Eligibility Criteria:
Inclusion Criteria:
Group 1:
* Age 18 and above.
* Subject minimum 26+0 weeks of pregnancy.
* Subject presents with feeling of vaginal wetness.
Group 2:
* Age 18 and above
* Subject minimum 36+0 weeks of pregnancy
* Subject presents with a feeling of vaginal wetness, and has applied the AMNIOSENSE Blue pad prior to arriving at the triage/delivery unit
Exclusion Criteria:
* Subject is unable or unwilling to comply with study procedures
* Subject with active vaginal bleeding present at the time of admission to triage
* Evidence of a non-reassuring fetal status at the time of assessment in triage (abnormal fetal heart tracing)
* Subject has reported to have had sexual intercourse within the last 12 hours
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03177135
Study Brief:
Protocol Section:
NCT03177135