Condition category
Neonatal Diseases
Date applied
16/11/2005
Date assigned
16/11/2005
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Hospital Sainte-Justine, Montréal (Canada)

Sponsor details

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

Sponsor type

Not defined

Website

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135835

Publication citations

  1. 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.

Additional files

Editorial Notes