Status:
UNKNOWN
Microbiome in Preterm Birth
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
University of Vienna
Conditions:
Vaginal Microbiome
Eligibility:
FEMALE
Brief Summary
The aims of this prospective longitudinal case-control pilot-study are (1) to characterize the changes of the vaginal, uterine and placental microbiome in pregnant women experiencing pPROM with immedi...
Detailed Description
A total of 100 study participants will be included, assigned to one of the following groups: Study group: • This group will consist of 50 pregnant women, who experienced pPROM between 22+5 and 28+0 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04489056
Start Date
July 27 2020
End Date
December 1 2021
Last Update
September 2 2020
Active Locations (1)
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1
Medical University of Vienna, Dept. of Obstetrics and Gynecology
Vienna, Austria, 1090