Table 1.

Requirements for participating centres and outcome definitions used in EECV2 Trial

	Definition
Requirements for participating centres	Participating centres must be able to:
	•ensure that an experienced clinician will undertake all ECV procedures
	•have the anaesthetic, obstetrical and nursing staff to be able to undertake a caesarean section, if necessary,usually within 30 minutes of making the decision to do so
	•provide suitable facilities and qualified neonatal staff who are able to resuscitate a baby with respiratorydepression by giving oxygen (by mask, bag and mask or ventilator)
	•provide ventilation by endotracheal intubation and positive pressure ventilation
	•give intravenous therapy and blood transfusion and use surfactant;
	•obtain a neonatal head ultrasound, if necessary.
Perinatal or neonatal mortality or serious neonatal morbidity	One or more of:
	•death (stillbirth or neonatal death 0–27 days after birth, excluding lethal anomalies)
	•birth trauma (spinal cord injury, basal skull fracture or depressed skull fracture, long bone fracture, peripheralnerve injury, subdural or intracerebral haemorrhage)
	•Apgar score of <4 at 5 minutes
	•abnormal level of consciousness (coma, stupor or decreased response to pain)
	•neonatal seizures before 72 hours of age
	•need for assisted ventilation for ≥24 hours via endotracheal tube initiated within 72 hours after birth
	•infection (septicaemia [positive blood culture] or meningitis [positive cerebrospinal fluid culture]) determinedwithin 72 hours of birth
	•necrotising enterocolitis
	•bronchopulmonary dysplasia
	•Grade III or IV intraventricular haemorrhage
	•cystic periventricular leucomalacia.
Serious fetal complications	One or more of:
	•preterm prelabour rupture of the membranes
	•placental abruption requiring obstetrical intervention to effect birth
	•preterm labour followed by preterm birth
	•abnormalities of the fetal heart rate before labour requiring obstetrical intervention to effect birth.
Maternal mortality or serious maternal morbidity	One or more of the following during pregnancy, labour, birth or within the first 28 days postpartum:
	•maternal death
	•haemorrhage (documented blood loss of >1500 mL, blood transfusion required, or need for dilation/curettage ormanual removal of the placenta after delivery),
	•laparotomy excluding caesarean section or tubal ligation
	•genital tract injury (hysterectomy, vulvar or perineal haematoma requiring evacuation, symptomatic broadligament haematoma confirmed by ultrasound, CT or MRI, intraoperative damage to bladder, ureter or bowelrequiring repair, fistula involving the genital tract, or third or fourth degree perineal tear involving the analsphincter and/ or mucosa)
	•thromboembolism (deep vein thrombosis, thrombophlebitis, or pulmonary embolism) requiring anticoagulanttherapy
	•systemic infection (temperature of 38.5°C or more on two or more occasions at least 24 hours apart notincluding the first 24 hours, or pneumonia [confirmed by X-ray], or sepsis [confirmed by blood culture]),
	•major medical life-threatening illness (such as adult respiratory distress syndrome, amniotic fluid embolism,disseminated intravascular coagulation, bowel obstruction, or paralytic ileus [requiring nasogastric suctioning])
	•wound infection (requiring prolongation of hospital stay, readmission to hospital or repeated treatment as anoutpatient), dehiscence, or breakdown
	•other serious maternal complication.