A multicentre randomised controlled trial of amnioinfusion

ISRCTN ISRCTN65963042
DOI https://doi.org/10.1186/ISRCTN65963042
Protocol serial number MCT-15221
Sponsor Hospital Sainte-Justine, Montréal (Canada)
Funder Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA 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 objectives1. 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) studiedMeconium aspiration syndrome
InterventionExperimental: 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 typeOther
Primary outcome measure(s)

Occurrence of perinatal death or moderate/severe meconium aspiration syndrome.

Key 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

Completion date30/04/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration1998
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/1999
Date of final enrolment30/04/2002

Locations

Countries of recruitment

  • United Kingdom
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • France
  • Mexico
  • Portugal
  • South Africa
  • Switzerland
  • Tunisia
  • United States of America
  • Uruguay

Study participating centre

Hôpital Sainte-Justine
Montréal
H3T 1C5
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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