Table 3 Components of the maternal and fetal composite outcomes
Outcome | Definition |
|---|---|
Maternal outcomes | |
 Mortality | Maternal death at any time in pregnancy after delivery until discharge |
 Hepatic dysfunction | INR >1.2 indicative of DIC in the absence of treatment with warfarin. (DIC is defined as having both abnormal bleeding and consumptive coagulopathy (i.e. low platelets, abnormal peripheral blood film, or one or more of the following: increased INR, increased PTT, low fibrinogen, of increased fibrin degradation products that are outside normal non-pregnancy ranges).) |
 Hepatic haematoma or rupture | Blood collection under the hepatic capsule as confirmed by ultrasound or laparotomy |
 Glasgow coma score <13 | From the GCS scoring system [39] |
 Stroke | Acute neurological event with deficits lasting longer than 48 h |
 Cortical blindness | Loss of visual acuity in the presence of intact papillary response to light |
 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 RPE (choroid) and is diagnosed by ophthalmological examination |
 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 |
 Transfusion of blood products | Includes transfusion of any units of blood products: FFP, platelets, RBCs, cryo or whole blood |
 Positive ionotropic 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) without enzyme changes and/or any one of the following: (1) development of new pathologic Q waves on serial ECGs. The patient may or may not remember previous symptoms. Biochemical markers of myocardial necrosis may have normalised, depending on the length of time that has passed since the infarct developed. (2) Pathological findings of an acute, healed or healing MI. (3) Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischaemic symptoms; (b) development of pathologic Q waves on the ECG; (c) ECG changes indicative of ischaemia (ST segment elevation or depression) or (d) coronary artery intervention (e.g. coronary angioplasty) |
 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 maybe by ventilation, electrical impedance tomography or continuous positive airway pressure |
 Pulmonary oedema | Clinical diagnosis with x-ray confirmation or requirement of diuretic treatment and SaO2 <94% |
 Postpartum haemorrhage | >1 L of blood loss after delivery |
 Early preterm delivery | Delivery at gestational age of less than 34 weeks |
Fetal outcomes | |
 Perinatal or infant mortality | Death of a fetus or neonate. Infant mortality is the death of a child less than 1 year of age |
 Bronchopulmonary dysplasia | Oxygen requirement at 36 weeks’ corrected gestation unrelated to an acute respiratory episode |
 Necrotising enterocolitis including only Bell’s stage 2 or 3 | Evidence of pneumotosis intestinalis on abdominal x-ray and/or surgical intervention |
 Grade III/IV intraventricular haemorrhage | Bleeding into the brain’s ventricular system, where the ventricles are enlarged by the accumulated blood or bleeding extends into the brain tissue around the ventricles |
 Cystic periventricular leukomalacia | Softening and necrosis in the hemispheric white matter in newborns that may result from impaired perfusion at the interface between the ventriculopetal and ventriculofugal arteries |
 Stage 3–5 retinopathy of prematurity | Abnormal blood vessel development in the retina of the eye, where blood vessel growth is severely abnormal, where there is a partially or totally detached retina |
 Hypoxic ischaemic encephalopathy | Apgar score ≤5 at 10 min and/or pH 7.00 in the first 60 min of life and/or base deficit ≥−16 in the first 60 min associated with an abnormal consciousness level (lethargy, stupor or coma) and seizures and/or poor/weak suck and/or hypotonia and/or abnormal reflexes |