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Microbiome in Preterm Birth

NCT04489056 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-09-02

No results posted yet for this study

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 immediate hospitalization and consecutive caesarean section at preterm, in comparison to uneventful term births with elective cesarean section, as well as (2) to evaluate the influence of the maternal on the neonatal microbiome and the early neonatal outcome in pPROM preterm cases, in comparison to uneventful term births.

The first aim will be achieved by collecting vaginal and rectal swabs for microbiome analysis in women experiencing pPROM, followed by uterine and placental swabs that are collected during the caesarean section. Control samples will be collected at the same time points from women undergoing elective caesarean section at term. The second aim will be achieved by microbiome analysis of rectal, oral/buccal, and skin swabs taken from newborns that are either born preterm after pPROM, or at term, both by caesarean section.

Conditions

  • Vaginal Microbiome

Interventions

GENETIC

Swabs for microbiome analysis

After informed consent, vaginal swabs will be collected during speculum examination from the lateral vaginal wall and posterior fornix vaginae using a sterile cotton swab combined with an epithelial brush. A rectal swab will be collected by insertion of a sterile swab into the anal sphincter. Intraoperative swabs of the placenta and uterine cavity will be collected during caesarean section under sterile conditions. Neonatal swabs (buccal mucosa and skin) will be collected directly after delivery and in the neonatal period. Stool samples will be taken from the meconium, defined as first stool of the infant and the stool of the newborn in the neonatal period.

Sponsors & Collaborators

  • University of Vienna

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Alex Farr, MD PhD · Medical University of Vienna

  • Herbert Kiss, MD MBA · Medical University of Vienna

  • Angelika Berger, MD MBA · Medical University of Vienna

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489056 on ClinicalTrials.gov