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Table 1 Specification of outcome measurements

From: Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial

Outcome

Defined as

Maternal infections

Two measurements of maternal temperature above 37,8 degrees Celsius at a 1 h interval plus a maternal pulse above 100 beats/min requiring treatment with antibiotics

Maternal side effects

Vaginal bleeding, discharge, discomfort and dyspareunia

BPD (severe 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

The presence of the characteristic clinical features of abdominal distention, 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 (catheterized 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 (catheterized 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)