A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
Starting soon · Phase 3
Conditions studied: Previable Labour With Intact Membranes
In brief
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.
Key facts
- Study ID
- NCT06572761
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 350
- Starts
- 2026-09-01
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Centre Hospitalier Poissy-Saint Germain — Poissy, France
Full record on ClinicalTrials.gov
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