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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01517633
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women age 18 years and older attending delivery room.
2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
3. Able and willing to read and sign an informed consent document.
Exclusion Criteria:
Subjects will be excluded from the study if any of the following will be present:
1. Prior use of any amniotic fluid detection test.
2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
4. Sexual intercourse within the past 24 hours.
5. Confirmed diagnosis of any vaginal infection within the past 7 days.
6. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
7. Patients unable or unwilling to participate.
8. Patients in active labor (or with regular contractions).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01517633
Study Brief:
Protocol Section:
NCT01517633