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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

  Definitions
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
   Seizure
   Lethargy
   Coma
   Fever
   Hypothermia
   Umbilical cord infection
   Skin infection
   Bleeding
   Jaundice
   Vomiting/Diarrhoea