PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes

Incidence of clinical chorioamnionitis, defined as maternal temperature ≥39.0°C once, or maternal temperature 38.0-38.9°C plus at least one of the following: leukocytosis >15,000/mm³, purulent cervical or vaginal discharge, fetal tachycardia (baseline fetal heart rate >160 bpm for ≥10 minutes), or malodorous liquor.

Incidence of intrapartum maternal fever, defined as axillary temperature ≥38.0°C on a single reading, or ≥37.5°C on two readings at least 1 hour apart during labour.

Incidence of postpartum fever, defined as axillary temperature ≥38.0°C recorded at any time after delivery until discharge during the index hospital admission.

Incidence of early postpartum endometritis diagnosed during the index hospital admission, defined as axillary temperature ≥38.0°C in the absence of an alternative identifiable cause and at least one associated clinical feature, including uterine tenderness, purulent or foul-smelling lochia, maternal tachycardia, or lower abdominal or uterine pain.

Incidence of peripartum infection, defined as the occurrence of clinical chorioamnionitis and/or early postpartum endometritis during the same hospital admission.

Incidence of systemic antibiotic therapy continued for more than 24 hours after delivery during the index hospital admission for suspected or confirmed infection, excluding routine single-dose perioperative prophylaxis for caesarean section.

Incidence of puerperal endometritis diagnosed after hospital discharge and up to 42 days postpartum, based on clinical documentation and/or requirement for antibiotic treatment for endometritis.

Incidence of wound infection involving the caesarean section wound and/or perineal wound or episiotomy within 42 days postpartum, as evidenced by clinical diagnosis and/or treatment such as antibiotics, wound drainage, opening, or debridement.

Incidence of infection-related hospitalisation longer than 5 days during the index admission and/or hospital readmission within 42 days postpartum with a primary diagnosis of infection and/or requiring systemic antibiotic therapy

Incidence of culture-proven early-onset neonatal sepsis, defined as isolation of a pathogenic organism from blood and/or cerebrospinal fluid culture, with clinical features consistent with infection.

Incidence of neonatal sepsis evaluation, defined as performance of a neonatal septic work-up including one or more of the following: blood culture, full blood count, or other investigations performed as part of routine neonatal sepsis assessment.

Incidence of admission to the neonatal intensive care unit at any time during the neonatal hospital stay, for any indication.

Incidence of a composite neonatal adverse outcome defined as the occurrence of one or more of the following: requirement for ventilator support, tachypnoea with or without oxygen supplementation persisting beyond 6 hours of life, temperature instability requiring clinical intervention, or requirement for second-line antibiotics.

Incidence of presumed early-onset neonatal sepsis, defined as culture-negative infants who receive at least 5 days of intravenous antibiotics based on clinical assessment, with or without supportive laboratory findings, as determined by the neonatal team.

Incidence of neonatal hospitalisation longer than 5 days primarily attributed to suspected or confirmed infection and/or readmission within 42 days of life with a primary diagnosis of infection and/or requiring intravenous antibiotic therapy.

Placental chorioamniotic tissue culture results obtained at delivery and categorized into predefined microbiological groups, including Enterobacteriaceae, Group B Streptococcus, anaerobes, Enterococcus faecalis, and negative cultures.