Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT06572761
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06572761
Study Brief:
Protocol Section:
NCT06572761