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Comparison of two prophylactic antibiotic regimens in case of preterm prelabor rupture of membranes before 34 weeks of gestation: a randomized controlled trial
EU CTIS ID: 2025-520842-31-00
What this study is testing
To demonstrate the superiority of the association ceftriaxone/azithromycin over the reference association amoxicillin/azithromycin on perinatal morbi-mortality in PPROM at 22 to 33WG.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- PPROM between 22 + 0/7 – 33 + 6/7 weeks of gestation, as diagnosed by obstetric team The diagnosis of PPROM is based on the combination of: (1) a suggestive clinical history AND (2) a physical examination (with or without a speculum) confirming discharge OR a positive laboratory test
- Eligible to the standard protocol of antibiotic prophylaxis for PPROM in inclusion centre
- Singleton gestation
- Foetus alive at the time of randomization
- 18 years of age or older
- French speaking
You likely can't join if
- Clinically suspected intra-uterine infection at the time of PPROM diagnosis (defined by association of PPROM AND fever (≥ 38°) AND at least two of the following signs: fetal tachycardia > 160 beats/min for 10 minutes, uterine pain or spontaneous labor, purulent amniotic fluid at the cervical os)
- Ongoing antibiotic treatment (≥ 24h) by amoxicillin, 3CG or a macrolide at the time of inclusion (other antibiotics are not cause for exclusion)
- Major foetal abnormality
- Maternal allergy or contra-indication to any antibiotic(s) used in the randomised trial protocol
- Current participation in another interventional study involving a drug
- A mental state that prevents understanding of the trial and the ability to give free and informed consent
See the full eligibility criteria
- PPROM between 22 + 0/7 – 33 + 6/7 weeks of gestation, as diagnosed by obstetric team The diagnosis of PPROM is based on the combination of: (1) a suggestive clinical history AND (2) a physical examination (with or without a speculum) confirming discharge OR a positive laboratory test
- Eligible to the standard protocol of antibiotic prophylaxis for PPROM in inclusion centre
- Singleton gestation
- Foetus alive at the time of randomization
- 18 years of age or older
- French speaking
- Affiliated to any French social security regime or equivalent system
- Informed consent signed
- Clinically suspected intra-uterine infection at the time of PPROM diagnosis (defined by association of PPROM AND fever (≥ 38°) AND at least two of the following signs: fetal tachycardia > 160 beats/min for 10 minutes, uterine pain or spontaneous labor, purulent amniotic fluid at the cervical os)
- Ongoing antibiotic treatment (≥ 24h) by amoxicillin, 3CG or a macrolide at the time of inclusion (other antibiotics are not cause for exclusion)
- Major foetal abnormality
- Maternal allergy or contra-indication to any antibiotic(s) used in the randomised trial protocol
- Current participation in another interventional study involving a drug
- A mental state that prevents understanding of the trial and the ability to give free and informed consent
- Persons deprived of their liberty by administrative or judicial order
- Persons under guardianship or conservatorship
- Person who is a relative of the investigator whom enrolled them in the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.