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Table 5 Definitions of CLIP Trial outcomes

From: Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol

Maternal 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
Perinatal outcomes
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
   Umbilical cord infection
   Skin infection