Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Pre… (NCT07200999) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
France250 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.