MACS: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study

ISRCTN	ISRCTN72654148
DOI	https://doi.org/10.1186/ISRCTN72654148
ClinicalTrials.gov number	NCT00187382
Secondary identifying numbers	MCT-38142 (for MACS-5 follow up: MCT-78775)

Submission date: 09/01/2004
Registration date: 10/02/2004
Last edited: 16/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Kellie Murphy
Scientific

790 Bay Street, 7th Floor
Toronto
M5G 1N8
Canada

Phone	+1 416-351-2530
Email	macs@sw.ca

Study information

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
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Patient information can be found on the website at: http://www.utoronto.ca/miru/macs/
Scientific title
Study acronym	MACS
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2004
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1900 (1858 participated in the MACS-5 follow up)
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	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

Study participating centre

790 Bay Street, 7th Floor

Toronto
M5G 1N8
Canada

Sponsor information

University of Toronto Faculty of Medicine Research Office (Canada)
University/education

1 Kings College Circle
# 2331
Toronto
Ontario
M5S 1A8
Canada

Phone	+1 416 978 5150
Email	medicine.vdr@utoronto.ca
Website	http://www.medresearch.utoronto.ca/fmro_about.html
"ROR"	https://ror.org/03dbr7087

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38142) (for MACS-5 follow up: MCT-78775)

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	20/12/2008		Yes	No