Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kellie Murphy
ORCID ID
Contact details
790 Bay Street
7th Floor
Toronto
M5G 1N8
Canada
+1 416-351-2530
macs@sw.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00187382
Protocol/serial number
MCT-38142 (for MACS-5 follow up: MCT-78775)
Study information
Scientific title
Acronym
MACS
Study hypothesis
In women at 26 to 30 weeks gestation who are at increased risk for preterm birth and remain undelivered 14 to 21 days following a single course of Antenatal CorticoSteroids (ACS), are multiple courses of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo?
MACS-5: A five year follow-up of Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study -
A follow up study was added to this trial in 2006 called MACS-5 (all details pertaining to this follow up only will be headed with the title MACS-5) with the hypothesis that the above will reduce the risk of death, or severe disability in neuromotor, neurosensory, or neurocognitive function, in children at five years of age.
Ethics approval
Research Ethics Board of Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario, Canada, 26 April 2001
MACS-5:
Research Ethics Board of Sunnybrook & Womens College Health Science Centre, Toronto, Ontario, Canada, 6 July 2005; Ethics approvals for centres in other countries are pending
Study design
Multicentre, multinational, two-arms randomised parallel trial, with study participant, investigator, caregiver, outcome assessor and data analysts blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found on the website at: http://www.utoronto.ca/miru/macs/
Condition
Pregnancies at increased risk of preterm birth
Intervention
1. Betamethasone (Celestone Soluspan):
Two doses, 12mg per dose, given IntraMuscular (IM) 24 hours apart - if risk of preterm birth continues, this will be repeated every 14 days until 33 completed weeks gestation.
2. Placebo:
Matching placebo of active treatment containing a dilute concentration of aluminum monostearate. Two doses, 12mg per dose, given IM 24 hours apart; if risk of preterm birth continues, this will be repeated every 14 days until 33 completed weeks gestation.
The contact for scientific queries for MACS-5 is:
Dr Elizabeth Vagi Asztalos
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada
Telephone: 416-323-6266
Email: elizabeth.asztalos@sunnybrook.ca
The contact for public queries for the MACS-5 trial is:
Edna Kavuma
MACS-5 Coordinator
Maternal Infant and Reproductive Health Research Unit (MIRU)
7th Floor
790 Bay Street
Toronto, Ontario
Canada
Telephone: 416-351-3818
Email: macs@sw.ca
The sponsor for the MACS-5 trial is:
Sunnybrook and Womens Health Sciences Centre
c/o Leslie Boehm, Director of Research Administration
S-130 2075 Bayview Avenue
Toronto, Ontario
M4N 3M5
Canada
Tel: 416-480-5720
Email: leslie.boehm@sw.ca
This trial has now finished recruiting, and the follow up MACS-5 will be completed on 31st December 2011.
Intervention type
Drug
Phase
Not Specified
Drug names
Antenatal corticosteroids
Primary outcome measure
Perinatal or neonatal mortality or serious neonatal morbidity (stillbirth or neonatal death; one or more of Respiratory Distress Syndrome [RDS], BronchoPulmonary Dysplasia [BPD], IntraVentricular Haemorrhage [IVH] grade III or IV, Cystic Peri-Ventricular Leucomalacia [PVL], Necrotizing EnteroColitis [NEC]) during the first 28 days of life or prior to hospital discharge, whichever is later.
MACS-5:
Primary outcome measured at five years of age of a child consisting of:
1. Death or impaired neuromotor (non-ambulatory cerebral palsy) or neurosensory function (blindness, deafness or need for visual or hearing aids), assessed by clinical exam
2. Abnormal attention, memory, or behaviour, assessed by parent administered questionnaire incorporating the Child Behaviour Checklist (1½ to 5) and the Behaviour Rating Inventory of Executive Function (Preschool version)
Secondary outcome measures
1. Death or neurological impairment (one or more of death, Cerebral Palsy [CP], Bayley Scales of Infant Development [BSID-II], Mental Development Index [MDI] less than 70).
2. Time point of measurement 18-24 months corrected gestational age.
MACS-5:
Measured at 5 years of age:
1. Measure of growth and blood pressure (height, weight, head circumference, systolic and diastolic Blood Pressure [BP]); assessed by clinical exam.
2. For children in English-speaking centres: intelligence and visual motor, visual spatial, and language skills; assessed by certified psychologists using the Weschler Preschool and Primary Intelligence Scale for Children - Third Edition (WPSSI-III), The Developmental Test of Visual Motor Integration - Fifth Edition (VMI) and Peabody Picture Vocabulary Test - Third Edition (PPVT-III).
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women who have previously received one completed course of ACS, 14 to 21 days ago, and continue to be at increased risk of preterm birth
2. Women of child-bearing age; their children from birth to 24 months corrected gestational age, either sex
3. Gestational age more than or equal to 26 weeks of gestation and less than 30 completed weeks
4. Women at 25 to 32 weeks gestation who remain at increased risk of preterm birth 14 to 21 days after a single course of antenatal corticosteroids
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1900 (1858 participated in the MACS-5 follow up)
Participant exclusion criteria
1. Women requiring chronic doses of corticosteroids secondary to medical conditions
2. Women with a contraindication to corticoosteroids
3. Women with clinical evidence of chorioamnionitis (temperature more than or equal to 38°C)
4. Known lethal congenital anomaly (e.g. anencephaly) in any fetus
5. First course of ACS given prior to 23 weeks
6. Previous participation in MACS
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Argentina, Bolivia, Brazil, Canada, Chile, China, Colombia, Denmark, Germany, Hungary, Israel, Jordan, Netherlands, Peru, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States of America
Trial participating centre
790 Bay Street, 7th Floor
Toronto
M5G 1N8
Canada
Sponsor information
Organisation
University of Toronto Faculty of Medicine Research Office (Canada)
Sponsor details
1 Kings College Circle
# 2331
Toronto
Ontario
M5S 1A8
Canada
+1 416 978 5150
medicine.vdr@utoronto.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38142) (for MACS-5 follow up: MCT-78775)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19101390
Publication citations
-
Results
Murphy KE, Hannah ME, Willan AR, Hewson SA, Ohlsson A, Kelly EN, Matthews SG, Saigal S, Asztalos E, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA, , Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial., Lancet, 2008, 372, 9656, 2143-2151, doi: 10.1016/S0140-6736(08)61929-7.