MACS: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study

ISRCTN ISRCTN72654148
DOI https://doi.org/10.1186/ISRCTN72654148
ClinicalTrials.gov (NCT) NCT00187382
Protocol serial number MCT-38142 (for MACS-5 follow up: MCT-78775)
Sponsor University of Toronto Faculty of Medicine Research Office (Canada)
Funder Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Contact information

Dr Kellie Murphy
Scientific

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

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

Study information

Primary study designInterventional
Study designMulticentre, multinational, two-arms randomised parallel trial, with study participant, investigator, caregiver, outcome assessor and data analysts blinded.
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymMACS
Study objectivesIn 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 & Women’s 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) studiedPregnancies at increased risk of preterm birth
Intervention1. 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 Women’s 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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Antenatal corticosteroids
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

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).

Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration1900
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2004
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • United Kingdom
  • Argentina
  • Bolivia
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Jordan
  • Netherlands
  • Peru
  • Poland
  • Russian Federation
  • Spain
  • Switzerland
  • United States of America

Study participating centre

790 Bay Street, 7th Floor
Toronto
M5G 1N8
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 20/12/2008 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
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