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

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.

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Key information

Conditions

Premature Rupture of Membranes Antibiotic Prophylaxis Beta-Lactams Drug Resistance, Bacterial Enterobacteriaceae Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Intrauterine Infection Obstetric Labor Complications Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier de Saint-Denis

Saint-Denis, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 1, 2025
Registry last updated: Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed