Condition category
Pregnancy and Childbirth
Date applied
09/01/2004
Date assigned
10/02/2004
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.utoronto.ca/macs

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 & Women’s 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 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 type

Drug

Phase

Not Specified

Drug names

Antenatal corticosteroids

Primary outcome measures

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

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

http://www.medresearch.utoronto.ca/fmro_about.html

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19101390

Publication citations

  1. 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.

Additional files

Editorial Notes