Actively Recruiting

FEMALE
ID06148480

Perinatal Transmission of Multi-drug Resistant Bacteria in Mothers and Infants at Northwestern Medicine Prentice Women's Hospital

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-01-13

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective surveillance study to understand the presence and transmission of multi-drug resistant Enterobacteriaceae (MDR-E), specifically extended spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E), among healthy postpartum women and their infants. This study focuses on mothers and infants admitted to Northwestern Medicine Prentice Women's Hospital, aiming to determine how common gut colonization with these resistant bacteria is among mothers and how often these strains are passed to their newborns. The research also seeks to identify genetic features linked to transmission, which may offer future targets for reducing colonization and spread. Participants include mothers who have delivered vaginally or by scheduled C-section without labor, along with their healthy infants who do not require neonatal intensive care. The study uses whole genome sequencing and comparative genomics to analyze the bacteria strains found in mother-infant pairs, assessing their genetic relatedness and shared characteristics. This approach will help test hypotheses about the prevalence of colonization, strain similarity between mothers and infants, and the genetic factors involved in transmission. During the study, mother-infant pairs are monitored shortly after birth with sample collection to detect ESBL-E colonization. Researchers measure the prevalence of colonization and transmission at baseline and reassess persistence seven days later. Genetic analysis of the bacteria is also performed at baseline. Participants undergo clinical assessments, and data on antibiotic exposure and delivery details are collected. The study helps improve understanding of how these resistant bacteria spread in early life and may guide future strategies to protect infant health.

CONDITIONS

Brief Title

Perinatal Transmission of MDR Bacteria

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women admitted to Northwestern Medicine Women's Hospital who have delivered an infant vaginally or by scheduled C-section without preceding labor
  • Infants born vaginally who are healthy and do not require transfer to the neonatal intensive care unit (NICU)
Not Eligible

You will not qualify if you...

  • Fever over 38 degrees Celsius during labor
  • Caesarean section performed after labor begins
  • Rupture of membranes or emergency delivery
  • Antibiotic use during the last trimester of pregnancy, including for Group B Streptococcus
  • Delivery before 35 weeks of gestation
  • Immunocompromised status, including HIV positive
  • Infant requires transfer to the neonatal intensive care unit (NICU) for any reason

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline (day of delivery)

Participants undergo testing to determine the presence and transmission of multi-drug resistant Enterobacteriaceae (MDR-E) strains between mothers and infants.

1 visit (in-person)

Long-term Monitoring

Duration - 7 days from baseline

Participants are observed to assess the persistence of MDR-E colonization in mothers and infants after birth.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Prentice Women's Hospital

Chicago, Illinois, United States, 60611

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Research Team

M

Mehreen Arshad

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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