Status:
NOT_YET_RECRUITING
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Previable Labour With Intact Membranes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 previ...
Detailed Description
Observational data suggest that subclinical infectious conditions can lead to spontaneous preterm labor. 10% of births are premature, but the morbidity/mortality of premature babies is concentrated ma...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06572761
Start Date
September 1 2024
End Date
May 1 2028
Last Update
August 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Poissy-Saint Germain
Poissy, France, 78300