A multicentre randomised controlled trial of amnioinfusion

ISRCTN	ISRCTN65963042
DOI	https://doi.org/10.1186/ISRCTN65963042
Secondary identifying numbers	MCT-15221

Submission date: 16/11/2005
Registration date: 16/11/2005
Last edited: 15/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr William Donald Fraser
Scientific

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

Phone	+1 (0) 514 345 4931 (4155)
Email	william.fraser@umontreal.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(s)	University Hospital of Québec Research Ethics Committee approved on the 26th June 2002.
Health condition(s) or problem(s) studied	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
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 study start date	01/04/1999
Completion date	30/04/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1998
Key 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
Key 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
Date of first enrolment	01/04/1999
Date of final enrolment	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

Study participating centre

Hôpital Sainte-Justine

Montréal
H3T 1C5
Canada

Sponsor information

Hospital Sainte-Justine, Montréal (Canada)
Not defined

3175 Chemin Côte Ste-Catherine
Room 4986-B
Montréal
H3T 1C5
Canada

"ROR"	https://ror.org/01gv74p78

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15221)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005		Yes	No