A multicentre randomised controlled trial of amnioinfusion

INTERVENTION: Experimental: Intrapartum transcervical infusion of 800 ml of sterile normal saline over a period of 40 minutes at 20 ml/min followed by continuous infusion up to total volume of 1500 ml Control: usual care CONDITION: Meconium aspiration syndrome ; Neonatal Diseases ; Meconium aspiration syndrome PRIMARY OUTCOME: Occurrence of perinatal death or moderate/severe meconium aspiration syndrome. SECONDARY OUTCOME: Maternal:; 1. Haemorrhage requiring blood transfusion; 2. Hysterectomy; 3. Uterine rupture; 4. Febrile morbidity; 5. Caesarean section; 6. Acceptability of amnioinfusion to women; 7. Determine the cost‐effectiveness of the procedure; ; Foetal:; 1. Foetal heart rate tracing abnormalities; 2. Positive blood or cerebrospinal fluid culture; 3. Convulsions; 4. Need for tube feeding; 5. Fractures and palsies; 6. Duration of oxygen supplementation; 7. Duration of ventilation; 8. Abnormal chest x‐ray INCLUSION CRITERIA: 1. Pregnant women of childbearing age, with a single baby in cephalic presentation 2. Ruptured membranes (spontaneous or artificial) 3. Gestational age greater than or equal to 36 weeks 4. Established labour defined as the presence of regular contractions occurring at 5 minute intervals 5. Cervical dilation between 2 and 7 cm inclusively at randomisation 6. Thick meconium 7. Foetal status considered as acceptable after a 30‐minute period of electronic foetal heart rate monitoring