PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial

Pregnant patients diagnosed with premature rupture of membranes (PROM)

The need for Neonatal ventilatory support will be evaluated at delivery and include at least one of the following measures:  Free-flowing oxygen in incubator  Low flow oxygen (≤ 2LPM)  High flow oxygen (≥ 3 LPM)  NCPAP or other NIV  Mechanical ventilation

Intraamniotic infection is evaluated by the objective measurement of maternal temperature, fetaltachycardia maternal white blood cells > 15000 per mm3, loss of purulent amniotic fluid in labor., Maternal infection will be evaluated on mothers re-admitted in the hospital until post-partum day 42 because of fever, purulent vaginal discharge or surgical site infection. Length of hospital stay will be recorded as a proxy of maternal/newborn complications. Maternal administration of antibiotics will be reported in terms of doses and quality, Neonatal infection is defined as the yield of a pathogen from blood or CSF coltures. Suspected infection is based on the presence of clinical symptoms and abnormal laboratory markers, i.e. an increase in C reactive proteins above 1.5 mg/dl., Neonatal pneumonia will be diagnosed in presence of a radiological evidence of persistent consolidation, cavitation or pleural effusion and evidence of worsening gas exchange associated with at least three clinical and/or laboratoristic signs Neonatal administration of antibiotics will be reported in terms of doses and quality, Tachysystole is defined as more of 5 uterine contractions in 10 minutes

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