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11 February 2012
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| [ Print-friendly version ] |
| A multicentre randomised controlled trial of amnioinfusion |
| ISRCTN | ISRCTN65963042 |
| ClinicalTrials.gov identifier | |
| Public title | A multicentre randomised controlled trial of amnioinfusion |
| Scientific title | A multicentre randomised controlled trial of amnioinfusion for thickly meconium stained amniotic fluid to reduce the risk of moderate to severe meconium aspiration syndrome or perinatal death |
| Acronym | N/A |
| Serial number at source | MCT-15221 |
| Study hypothesis |
1. To assess when compared to standard care, a policy of amnioinfusion for thickly meconium stained amniotic fluid reduces the risk of either moderate to severe meconium aspiration syndrome or perinatal death
2. To assess the effects of amnioinfusion on the risk of occurrence of other indicators of neonatal morbidity, cesarean section and indicators of severe maternal morbidity 3. Will evaluate the acceptability of amnioinfusion to women and determine the cost-effectiveness of the procedure |
| Lay summary | |
| Ethics approval | University Hospital of Québec Research Ethics Committee approved on the 26th June 2002. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Argentina, Belgium, Brazil, Canada, France, Mexico, Portugal, South Africa, Switzerland, Tunisia, United Kingdom, United States of America, Uruguay |
| Disease/condition/study domain | Meconium aspiration syndrome |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/1999 |
| Anticipated end date | 30/04/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1998 |
| 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: usual care |
| Primary outcome measure(s) |
Occurrence of perinatal death or moderate/severe meconium aspiration syndrome.
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| Secondary outcome measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15221) |
| Trial website | |
| Publications | 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135835 |
| Contact name | Dr William Donald Fraser |
| Address |
Hôpital Sainte-Justine
Département d'Obstétrique-Gynécologie 3175, Chemin de la Côte-Ste-Catherine 4e Étage, Bloc 9, Local 4986-B |
| City/town | Montréal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4931 (4155) |
| Fax | +1 514 345 2195 |
| william.fraser@umontreal.ca | |
| Sponsor | Hospital Sainte-Justine, Montréal (Canada) |
| Address |
3175 Chemin Côte Ste-Catherine
Room 4986-B |
| City/town | Montréal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Date applied | 16/11/2005 |
| Last edited | 04/03/2009 |
| Date ISRCTN assigned | 16/11/2005 |
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