Contact information
Type
Scientific
Primary contact
Dr William Donald Fraser
ORCID ID
Contact details
Hôpital Sainte-Justine
Département d'Obstétrique-Gynécologie
3175
Chemin de la Côte-Ste-Catherine
4e Étage
Bloc 9
Local 4986-B
Montréal
H3T 1C5
Canada
+1 (0) 514 345 4931 (4155)
william.fraser@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-15221
Study information
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
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
Ethics approval
University Hospital of Québec Research Ethics Committee approved on the 26th June 2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Meconium aspiration syndrome
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Occurrence of perinatal death or moderate/severe meconium aspiration syndrome.
Secondary outcome measures
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
Overall trial start date
01/04/1999
Overall trial end date
30/04/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1998
Participant 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
Recruitment start date
01/04/1999
Recruitment end date
30/04/2002
Locations
Countries of recruitment
Argentina, Belgium, Brazil, Canada, France, Mexico, Portugal, South Africa, Switzerland, Tunisia, United Kingdom, United States of America, Uruguay
Trial participating centre
Hôpital Sainte-Justine
Montréal
H3T 1C5
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15221)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135835
Publication citations
-
Results
Fraser WD, Hofmeyr J, Lede R, Faron G, Alexander S, Goffinet F, Ohlsson A, Goulet C, Turcot-Lemay L, Prendiville W, Marcoux S, Laperrière L, Roy C, Petrou S, Xu HR, Wei B, , Amnioinfusion for the prevention of the meconium aspiration syndrome., N. Engl. J. Med., 2005, 353, 9, 909-917, doi: 10.1056/NEJMoa050223.