A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor

Phase 3

Not yet recruiting

• Conditions: Previable Labour With Intact Membranes

• Registration Number: NCT06572761
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

Inclusion Criteria:<br><br> - Threatened previable prelabor with intact membranes between 18weeks of gestation<br> +0/7 and 23 weeks of gestation 6/7 SA defined on endovaginal ultrasound by a short<br> cervix =10 mm, and/or protrusion of the membranes on speculum examination.<br><br> - Maternal age >18 years<br><br> - Affiliated with social security<br><br> - Correct understanding of the French language<br><br> - Singleton pregnancy<br><br> - Foetus alive at time of inclusion<br><br> - Absence of regular and painful uterine contractions<br><br>Exclusion Criteria:<br><br> - Premature labor defined by regular, painful uterine contractions and a short cervix<br><br> - Protected person (patient under guardianship/curatorship/or legal protection)<br><br> - Multiple pregnancies<br><br> - Premature rupture of membranes<br><br> - Acute chorioamnionitis<br><br> - Contraindication to protocol antibiotics<br><br> - Chromosomal abnormality, congenital malformation<br><br> - Patients who received antibiotics before randomization, or requiring antibiotics for<br> another indication (chorioamnionitis, pyelonephritis, etc.)<br><br> - Participation in another research (Specify the category: RIPH, EC, IC, etc.) or<br> being in the exclusion period following previous research involving humans, if<br> applicable<br><br> - Patient under AME (if no exemption from affiliation)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A perinatal composite outcome

Secondary Outcome Measures

Name	Time	Method
Gestationnal age at delivery;Maternal Morbidty;Bacteriological