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

Intrapartum Maternal Fever

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.

Time frame: From admission (diagnosis of PROM) until delivery (72 hours)

Postpartum Fever During Index Admission

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

Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum

Early Postpartum Endometritis During Index 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.

Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum

Peripartum Infection During Index Admission

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

Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum

Postpartum Antibiotic Treatment Exceeding 24 Hours

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.

Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum

Puerperal Endometritis After Discharge

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.

Time frame: From discharge until 42 days postpartum.

Wound Infection

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.

Time frame: From delivery until 42 days postpartum.

Infection-related Hospitalisation Longer Than 5 Days or Readmission for Infection

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

Time frame: From delivery until 42 days postpartum.

Culture-proven Early-onset Neonatal Sepsis

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.

Time frame: Within the first 72 hours of life

Neonatal Sepsis Evaluation

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.

Time frame: From birth till 7 days of life

NICU Admission

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

Time frame: From birth till 7 days of life

Composite Neonatal Adverse Outcome

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.

Time frame: From birth till 7 days of life

Presumed Early-onset Neonatal Sepsis

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.

Time frame: From birth till 7 days of life.

Infection-related Neonatal Hospitalisation Longer Than 5 Days or Readmission

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.

Time frame: From birth until 42 days of life.

Placental Chorioamniotic Tissue Culture

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.

Time frame: At delivery