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Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study

Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07200999
Enrollment
250
Registered
2025-10-01
Start date
2025-10-01
Completion date
2026-12-15
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, Beta-Lactams, Drug Resistance, Bacterial, Enterobacteriaceae, Intrauterine Infection, Pregnancy, Premature Rupture of Membranes

Brief summary

This study looks at how common certain antibiotic-resistant bacteria (called extended-spectrum beta-lactamase-producing Enterobacteriaceae, or E-BLSE) are in pregnant women who experience premature breaking of their water before full term. The goal is to understand how often these bacteria are found, how long they stay, and what factors increase the risk of carrying them. This information will help doctors choose the best antibiotics to protect both the mother and baby from infections during and after pregnancy. The study follows women from the time of their membrane rupture until delivery, collecting samples to track the bacteria over time.

Interventions

None listed

Sponsors

Centre Hospitalier de Saint-Denis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

: * Pregnant women aged over 18 years * Diagnosed with premature rupture of membranes before term (between 23 weeks + 0 days and 36 weeks + 6 days of gestation) * Managed in one of the participating maternity hospitals

Exclusion criteria

: * No available microbiological sample * Minors or women under legal guardianship (curatorship, tutelage, or judicial protection) * Women who refuse the use of their clinical data for research purposes at admission or within one month after receiving the information document

Design outcomes

Primary

MeasureTime frame
The proportion of vaginal swabs (PV) positive for extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-BLSE) in pregnant women with premature rupture of membranes before term, measured at diagnosis, during the latency period, and at delivery.1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026