Premature Rupture of MembranesNCT07200999
Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
An observational study of Premature Rupture of Membranes and Enterobacteriaceae, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Rupture of Membranes, Enterobacteriaceae, Beta-Lactams
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Premature Rupture of Membranes, Enterobacteriaceae, Beta-Lactams, Drug Resistance, Bacterial, Antibiotic Prophylaxis, Pregnancy
- Medical subject headings
- Fetal Membranes, Premature Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200999
- Sponsor's protocol ID
- 0117_SMIT
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07200999
- Acronym / sponsor ID
- 0117_SMIT
- Conditions
- Premature Rupture of Membranes, Enterobacteriaceae, Beta-Lactams, Drug Resistance, Bacterial, Antibiotic Prophylaxis, Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Rupture of Membranes and Enterobacteriaceae, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.