Table 5 Definitions of CLIP Trial outcomes

Mortality

Defined as the number of deaths during pregnancy or within 42 days of pregnancy (or last contact day if contact not maintained to 42 days)/1000 identified pregnancies), termed maternal death rate.

Morbidities

Defined as the number of women with one or more life-threatening complications of pregnancy during pregnancy or within 42 days of pregnancy/1000 identified pregnancies.

Serious end-organ complications of pre-eclampsia:

   Eclampsia: occurrence of generalized convulsions during pregnancy, labour or within 42 days of delivery in the absence of epilepsy or another condition predisposing to convulsions

Stroke: hemiparesis and/or blindness developed during pregnancy or in the 42 days postpartum lasting greater than 48 h

   Coma: prolonged unconsciousness ≥12 h

   Antepartum haemorrhage: vaginal bleeding ≥15 mL with or without pain before the onset of labour

   Disseminated intravascular coagulation (DIC): abnormal bleeding from mucosa (mouth and/or ears)

Other major causes of maternal mortality:

   Obstetric sepsis: In the community, defined as fever and one of: abdominal/uterine tenderness, foul smelling vaginal discharge/lochia, productive cough and shortness of breath, dysuria or flank pain, headache and neck stiffness. In the facility, defined as presence of fever (>38 °C), a confirmed or suspected infection (e.g. chorioamnionitis, septic abortion, endometritis, pneumonia) and at least one of the following: heart rate >90/min, respiratory rate >20/min, leukopoenia (total leukocyte count [TLC] <4 × 10⁹/L) or leukocytosis (TLC >12 × 10⁹/L)

   Vesicovaginal or rectovaginal fistula: continuous loss of urine and/or faeces after delivery

Life-saving interventions:

   Cardiopulmonary resuscitation: a set of emergency procedures including chest compressions and lung ventilation applied in cardiac arrest victims

   Dialysis: haemodialysis and/or peritoneal dialysis

   Mechanical ventilation (other than for Caesarean section): intubation and ventilation not related to anaesthesia

   Blood transfusion: ≥1 unit

   Interventions for major postpartum haemorrhage: brace sutures, external and internal uterine compression, anti-shock garment use, internal iliac artery ligation and/or hysterectomy with or without transfusion

Mortality

Defined as stillbirth [≥20⁺⁰ and/or ≥500 g], early neonatal mortality [days 0–7 of postnatal life] and late neonatal mortality [days 8–28 of postnatal life]/1000 identified pregnancies]

Morbidity

Defined as non-lethal events of seizure and coma during days 0–28 of postnatal life/1000 identified pregnancies). The following are the primary neonatal morbidities:

   Feeding difficulty

   Breathing difficulty

   Seizure

   Lethargy

   Coma

   Fever

   Hypothermia

   Umbilical cord infection

   Skin infection

   Bleeding

   Jaundice

   Vomiting/Diarrhoea