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

NCT07200999 | Not Yet Recruiting

• 1 other identifier: 0117_SMIT
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants will be selected from pregnant women who experience premature rupture of membranes before term (between 23 weeks and 36 weeks + 6 days of gestation). These women will be receiving care at multiple maternity hospitals participating in this multicenter French study. The population includes adult women (over 18 years old) who have vaginal microbiological samples available for analysis. This group represents a high-risk pregnancy population due to the increased risk of infection associated with premature membrane rupture.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hospitalier de Saint-Denis

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-07

Locations

FR (1)