Secondary outcomes
bleeding, death, pulmonary haemorrhage, seizure, blood loss, birthNausea, vomiting and dizziness, organ dysfunction, pain, dizziness, intracranial haemorrhage, 10Pain, adverse skin reactions, bruising, nausea,, sepsis
THROMBOEMBOLIC EVENT, BLEEDING, BLOOD LOSS, ADVERSE EVENTS, INTRAOPERATIVE BLOOD LOSS, SEPSIS
Specific to caesarean births:Intraoperative blood loss measured by quantifying the amount of blood in sponges and drapes used in surgery and blood loss from suctioning, excluding amniotic fluidSurgery durationIntraoperative whole blood/red cell transfusionPostoperative haemoglobin (Hb) or packed cell volume (PCV) up to the end of the second postoperative day, if knownAll births:Postpartum blood loss measured using a calibrated obstetric drape starting immediately after vaginal birth or once the women are shifted to a bed in the observation area after CS surgery, for 1 h, or up to 2 h if bleeding continues after 1 h and the woman remains in bedBlood pressure and heart rate (lowest recorded blood pressure reading and associated heart rate) up to 24 h after birthInterventions for bleeding (uterotonics, non-trial TXA, blood transfusion, surgical and non-surgical interventions) within 24 h of birthNausea, vomiting and dizziness (when the calibrated drape is removed, the woman will be asked about her nausea, vomiting and dizziness during and since the birth) measured using the number of episodes and/or a score from 1 to 10Pain or adverse skin reactions at injection sites (when the calibrated drape is removed, each injection site will be inspected for local reactions and the woman will be asked about pain at her injection sites)Prespecified maternal adverse events up to discharge, death or 42 days postpartum (thromboembolic events, seizure, sepsis, organ dysfunction, coagulopathy)Other maternal adverse events up to discharge, death or 42 days postpartumMaternal mortality up to discharge, death or 42 days postpartum (all-cause, cause-specific, narrative)Length of hospital stayDays in intensive care unit (ICU)/high dependency unit (HDU)Transfer to another hospitalPrespecified neonatal outcomes up to discharge, death or 42 days (breastfeeding, intracranial haemorrhage, pulmonary haemorrhage, bruising, thromboembolic event, seizure, stillbirth/intrapartum death, neonatal death, cause of death, congenital and genetic abnormalities, adverse events)