Population of study participants Pregnant women with PPROM at 22 to 33 weeks’ gestation
Conditions
Brief summary
Composite outcome including foetal death and/or neonatal death AND/OR neonatal severe morbidity (defined by ≥ 1 of the following: mechanical ventilation 48hrs, severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, white matter injury, neonatal early-onset sepsis, neonatal late-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).
Detailed description
Pregnancy duration, Maternal infectious morbidity, Neonatal mild or moderate morbidity: 1. Prevalence of maternal or neonatal colonization/infection with ESBL- or 3rd generation cephalosporin-resistant- enterobacteria ; 2. Psycho-motor development at the age of 2 years by parental auto-questionnaire
Interventions
DRUGCEFTRIAXONE
DRUGAMOXICILLIN
DRUGAZITHROMYCIN
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome including foetal death and/or neonatal death AND/OR neonatal severe morbidity (defined by ≥ 1 of the following: mechanical ventilation 48hrs, severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, white matter injury, neonatal early-onset sepsis, neonatal late-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy duration, Maternal infectious morbidity, Neonatal mild or moderate morbidity: 1. Prevalence of maternal or neonatal colonization/infection with ESBL- or 3rd generation cephalosporin-resistant- enterobacteria ; 2. Psycho-motor development at the age of 2 years by parental auto-questionnaire | — |
Outcome results
None listed