A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatene… (NCT06572761) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
France350 participantsStarted 2026-09
Plain-language summary
The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Threatened previable prelabor with intact membranes between 18weeks of gestation +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short cervix ≤10 mm, and/or protrusion of the membranes on speculum examination.
* Maternal age \>18 years
* Affiliated with social security
* Correct understanding of the French language
* Singleton pregnancy
* Foetus alive at time of inclusion
* Absence of regular and painful uterine contractions
Exclusion Criteria:
* Premature labor defined by regular, painful uterine contractions and a short cervix
* Protected person (patient under guardianship/curatorship/or legal protection)
* Multiple pregnancies
* Premature rupture of membranes
* Acute chorioamnionitis
* Contraindication to protocol antibiotics
* Chromosomal abnormality, congenital malformation
* Patients who received antibiotics before randomization, or requiring antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
* Participation in another research (Specify the category: RIPH, EC, IC, etc.) or being in the exclusion period following previous research involving humans, if applicable
* Patient under AME (if no exemption from affiliation)