Table 1 Definitions of secondary outcome measures

Maternal infections

Two measurements of maternal temperature above 37,8 degrees Celsius at a one hour interval and a maternal pulse >100 beats per minute requiring treatment with antibiotics

Maternal side effects

Vaginal discharge, bleeding, discomfort, dyspareunia, cervical laceration

Chronic lung disease

Babies born before 32 weeks: need for >30% oxygen, with or without positive pressure ventilation or continuous positive pressure at 36 weeks postmenstrual age, or discharge (whichever comes first).

Babies born after 32 weeks: need for >30% oxygen with or without positive pressure ventilation or continuous positive pressure at 56 days postnatal age, or discharge (whichever comes first).

IVH > grade II

Haemorrhage in the germinal matrix, ventricles, or cerebral parenchyma; observed on ultrasound examination or MRI

PVL > grade I

Periventricular lucency in the white matter

NEC > stage I

Defined as the presence of the characteristic clinical features of abdominal distension, with or without rectal bleeding, and abdominal radiographic finding associated with pneumatosis intestinalis

Early sepsis

If prior to or at 72 h of life the infant had an infection marked by positive blood, CSF, or urine (catheterised or suprapubic) cultures with or without suspicious clinical findings of infection on physical examination.

Late sepsis

If after 72 h of life the infant had an infection marked by positive blood, CSF, or urine (catheterised or suprapubic) cultures with or without suspicious clinical findings of infection on physical examination

OR

if there is clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection and often cardiovascular decomposition

Neonatal meningitis

Suspected or proven (caused by any pathogen)