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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT04489056
Eligibility Criteria:
Inclusion Criteria:
* Maternal age ≥18 years at the time of study enrollment
* Singleton pregnancy
* Signed informed consent
* Confirmed preterm premature rupture of membranes (pPROM) or elective cesarean section for term birth (depending on study group)
* Gestational age at the time of pPROM between 22+5 and 28+0 weeks or ≥37+0 gestational weeks at the time of term cesarean section (depending on study group)
Exclusion Criteria:
* Maternal age \<18 years at the time of study enrollment
* Multiple pregnancy
* Inability to consent to the participation in the study
* Ongoing antibiotic treatment or antibiotic treatment ≤2 weeks before study enrollment
* Vaginal sexual intercourse within 48 hours before study enrollment
* Fresh vaginal bleeding within 48 hours before study enrollment
* Maternal Hepatitis-B or Hepatitis-C infection (i.e., positive on PCR)
* Maternal HIV-infection (i.e., positive on PCR)
* Maternal diabetes mellitus or gestational diabetes
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04489056
Study Brief:
Protocol Section:
NCT04489056