RECRUITING
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Perinatal Transmission of MDR Bacteria
We aim to conduct a prospective surveillance study of mothers and their infants born vaginally or by scheduled C-section and who are admitted to Northwestern Medicine Prentice Women's Hospital to determine the prevalence of ESBL-E carriage in healthy post-partum women and the transmission rate of these strains to their infants. Using whole genome sequencing and a comparative genomics approach we will determine the relatedness of strains among mother-infant dyads as well as identify genetic regions common to transmitted strains. We hypothesize that; 1) given the diverse population of Chicago there will be a significant rate of gut colonization with ESBL-E among mothers admitted to Prentice, 2) ESBL-E strains isolated from neonates will be identical to those from their mothers and 3) genetic determinants of transmission are conserved across ESBL E. coli strains that are perinatally transmitted. These hypotheses will be tested using the following Aims: Aim 1: Determine the prevalence of ESBL-E gut colonization and rate of perinatal transmission among mother-infant dyads Aim 2: Identify genetic determinants of transmission common to ESBL E. coli that are perinatally transmitted. Our long-term goal is to understand the unique features of persistent gut and vaginal ESBL-E colonizers and identify genetic and molecular elements that could be attractive therapeutic targets to decrease the burden of ESBL-E colonization and perinatal transmission.
Conditions:
🦠 E. Coli Infection 🦠 Multi-antibiotic Resistance
🗓️ Study Start (Actual) 17 July 2020
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Women that are admitted to Northwestern Medicine Women's Hospital that have delivered an infant vaginally or have had a scheduled C-section without preceding labor. Infants that are born vaginally who are healthy and do not require transfer to the NICU for any reason.

    Exclusion Criteria:

    • Temperature \>38 Celsius in labor, caesarean section after labor, rupture of membranes or done emergently, antibiotic use in last trimester including for GBS+, delivery at \<35 weeks, immunocompromised host including being HIV+, infant requiring transfer to NICU for any reason and infants who are transferred to the NICU.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 November 2023
  • First Submitted that Met QC Criteria 20 November 2023
  • First Posted 28 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 November 2023
  • Last Update Posted 28 November 2023
  • Last Verified November 2023
I'm interested ...!!