dinoprostone for Premature rupture of membranes (PROM)

Inclusion criteria

• {"criterion_text":"- Gestational age ≥ 37 weeks\n- Negative rectovaginal GBS swab\n- Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min)\n- Cephalic presentation\n- Age ≥18 years of age at the time of randomization\n- Ability to provide an informed consent\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Prematurity (<37 weeks)\n- GBS positive vagino-rectal swab or with an unknown swab\n- Multiple pregnancies\n- Previous cesarean section (CS)\n- Breech presentation, transverse lie or other indication for elective CS\n- Suspected clinic for intra-amniotic infection (According to the Triple I criteria)\n- Stained amniotic fluid\n- Alterations of the FHR\n- Unknown exact ROM time\n- Known hypersensitivity to drugs for IOL or their excipients\n- Presence of unknown vaginal bleeding\n- Presence of maternal kidney disease (GFR <15 ml/min/1,73 m2).\n- Every condition contraindicating vaginal delivery"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Evaluated at delivery; defined as the presence of at least one of: free-flowing oxygen in incubator; low flow oxygen (≤2 LPM); high flow oxygen (≥3 LPM); NCPAP or other non-invasive ventilation (NIV); mechanical ventilation."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Evaluated by objective measurement of maternal temperature, fetal tachycardia, maternal white blood cells >15,000/mm3, and loss of purulent amniotic fluid during labor."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessed by hospital readmission up to post-partum day 42 for fever, purulent vaginal discharge or surgical site infection; length of stay recorded; maternal antibiotic administration reported (doses and quality)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Neonatal infection: pathogen yield from blood or CSF cultures. Suspected infection: clinical symptoms plus abnormal labs (CRP >1.5 mg/dl)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnosis requires radiological evidence (persistent consolidation, cavitation or pleural effusion), worsening gas exchange, and at least three clinical and/or laboratory signs; neonatal antibiotic administration will be recorded (doses and quality)."}
• {"endpoint_text":"- Tachysystole is defined as more of 5 uterine contractions in 10 minutes","definition_or_measurement_approach":"Defined as more than 5 uterine contractions in 10 minutes."}

Italy

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

396

Number Of Sites

17

Number Of Participants

1400

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy