Table 1 Full definitions of individual components of the primary short-term maternal outcome

Mortality

Maternal death occurring before primary discharge from hospital

Hepatic dysfunction

Elevated liver enzymes (alanine transaminase or aspartate transaminase ≥ 70 IU/L)

Hepatic hematoma or rupture

Blood collection under the hepatic capsule as confirmed by ultrasound or laparotomy

Glasgow coma score < 13

Based on GCS scoring system [12]

Stroke

Acute neurological event with deficits lasting longer than 48 h

Cortical blindness

Loss of visual acuity in the presence of intact pupillary response to light

Reversible ischaemic neurologic deficit (RIND)

Cerebral ischaemia lasting longer than 24 h but less than 48 h revealed through clinical examination

Retinal detachment

Separation of the inner layers of the retina from the underlying retinal pigment epithelium (RPE; choroid) and is diagnosed by ophthalmological exam

Acute renal insufficiency

For women with an underlying history of renal disease: defined as creatinine > 200 μM; for patients with no underlying renal disease: defined as creatinine > 150 μM

Dialysis

Including haemodialysis and peritoneal dialysis

Postpartum haemorrhage (PPH) requiring transfusion or hysterectomy

Occurrence of PPH that required transfusion or hysterectomy

Placental abruption

Any occurrence of abruption diagnosed clinically or based on placental pathology report

Platelet count < 50,000 without blood transfusion

Measurement of platelet count recorded as less than 50,000 without patient being given a blood transfusion

Transfusion of blood products

Includes transfusion of any units of blood products: fresh frozen plasma (FFP), platelets, red blood cells (RBCs), cryoprecipitate (cryo) or whole blood. Includes request for transfusion even if products unavailable at time of request.

Positive inotropic support

The use of vasopressors to maintain a systolic blood pressure > 90 mmHg or mean arterial pressure > 70 mmHg

Myocardial ischaemia/infarction

ECG changes (ST segment elevation or depression) with ischaemic symptoms with or without typical enzyme changes

Eclampsia

Any episode of seizure antepartum, intrapartum or before postpartum discharge as follow-up beyond discharge is not possible

Require > 50% oxygen for greater than 1 h

Oxygen given at greater than 50% concentration based on local criteria for longer than 1 h

Intubation other than for Caesarean section

Intubation may be by endotracheal tube insertion or continuous positive airway pressure

Severe breathing difficulty

Suspected pulmonary oedema where X-ray confirmation is unavailable may be diagnosed by presence of chest pain or dyspnoea, crackles in the lungs and SaO₂ < 90%

Pulmonary oedema

Clinical diagnosis with X-ray confirmation or requirement of diuretic treatment and SaO₂ < 95%

Severe hypertension

Systolic blood pressure of ≥ 160 mmHg between randomisation and post-delivery discharge