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Trials - SLCTR/2021/023

Protocol Change

Date

2023-10-19


Protocol

Protocol changed


Item Changed

Primary outcome(s) - Time of assessment(s)


Previous Version

1.Vaginal delivery rate [At the time of hospital discharge ] 2.Perinatal morbidity and mortality parameters (composite measure) a. Stillbirth b. Admission to neonatal intensive care unit (NICU- for any period) c. Birth trauma (mechanical causes during childbirth) d. Intrapartum death e. Neonatal mortality f. Neonatal seizures g. Confirmed neonatal infection needing antibiotics h. Hypoxic-ischaemic encephalopathy (HIE) i. Meconium aspiration syndrome (MAS) j. Severe neonatal respiratory morbidity (consists of mechanical ventilation, infantile respiratory distress syndrome (RDS) and pneumothorax) [At the time of hospital discharge ]


Next Version

2.Perinatal morbidity and mortality parameters (composite measure) Stillbirth, Admission to neonatal intensive care unit (NICU- for any period), Endotracheal intubation, Cord prolapse, External cardiac compressions, Neonatal death, Neonatal seizures, Neonatal infection either clinically suspected (with supporting laboratory evidence, eg, raised white blood cell count or C-reactive protein) or proven neonatal infection (culture proven) requiring antibiotics, Hypoxic-ischaemic encephalopathy (HIE) of any stage, Meconium aspiration syndrome (MAS), Need for respiratory support with NICU admission, Birth trauma (severe bruising, nerve trauma, or fracture), Neonatal Apgar score less than 7 at 5 minutes of birth, Umbilical arterial pH < 7.1 or acidosis [At the time of hospital discharge]