Meconium aspiration syndrome Neonatal Diseases Meconium aspiration syndrome
Conditions
Interventions
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: usua
Sponsors
Hospital Sainte-Justine, Montréal (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Cord prolapse 2. Known or suspected major foetal anomaly 3. Suspicion of chorioamnionitis on the basis of maternal fever or abnormal vaginal discharge 4. Known placenta praevia or virginal bleeding due to other causes 5. Known intravenous drug user 6. Patient known or suspected to be at high risk of human immunodeficiency virus (HIV) 7. Hepatitis B or C 8. Active genital herpetic lesions 9. Uterine over distension 10. Previous uterine incision other than low transverse 11. Recurrent late decelerations 12. Prolonged decelerations 13. Scalp blood pH less than 7.15 14. Any contradictions to labour 15. Unable to comprehend the consent form 16. Use of narcotic analgesics prior to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of perinatal death or moderate/severe meconium aspiration syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Belgium, Brazil, Canada, France, Mexico, Portugal, South Africa, Switzerland, Tunisia, United Kingdom, United States of America, Uruguay
Outcome results
None listed