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Original Investigation | Comparative Effectiveness Research

Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study:  Outcomes in Children at 5 Years of Age (MACS-5)

Elizabeth V. Asztalos, MD1; Kellie E. Murphy, MD2; Andrew R. Willan, PhD3; Stephen G. Matthews, PhD4; Arne Ohlsson, MD5; Saroj Saigal, MD6; B. Anthony Armson, MD7; Edmond N. Kelly, MB5; Marie-France Delisle, MD8; Amiram Gafni, DSc9; Shoo K. Lee, MBBS5; Renee Sananes, PhD10; Joanne Rovet, PhD11; Patricia Guselle, MIR12; Kofi Amankwah, MD13; Mariam Saleem, MIPH13; Johanna Sanchez, MIPH13 ; for the MACS-5 Collaborative Group
[+] Author Affiliations
1Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada
2Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
3Program in Child Health Evaluative Sciences, SickKids Research Institute, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
4Departments of Physiology, Obstetrics and Gynaecology, and Medicine, University of Toronto, Toronto, Ontario, Canada
5Department of Paediatrics, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
6Department of Paediatrics, McMaster University Medical Centre, Hamilton, Ontario, Canada
7Department of Obstetrics and Gynaecology, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada
8Department of Obstetrics and Gynaecology, BC Women’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
9Centre for Health Economics and Policy Analysis, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
10Department of Psychology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
11Neuroscience and Mental Health Program, The Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada
12The Hospital for Sick Children, Toronto, Ontario, Canada
13The Centre for Mother, Infant, and Child Research, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, Ontario, Canada
JAMA Pediatr. 2013;167(12):1102-1110. doi:10.1001/jamapediatrics.2013.2764.
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Importance  A single course of antenatal corticosteroid therapy is recommended for pregnant women at risk of preterm birth between 24 and 33 weeks’ gestational age. However, 50% of women remain pregnant 7 to 14 days later, leading to the question of whether additional courses should be given to women remaining at risk for preterm birth. The Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) was an international randomized clinical trial that compared multiple courses of antenatal corticosteroids with a single course in women at risk of preterm birth.

Objective  To determine the effects of single vs multiple courses of antenatal corticosteroid therapy on death or neurodevelopmental disability (neuromotor, neurosensory, or neurocognitive/neurobehavioral function) at 5 years of age in children whose mothers participated in MACS. Our secondary aims were to determine the effect on height, weight, head circumference, blood pressure, intelligence, and specific cognitive (visual, spatial, and language) skills.

Design, Setting, and Participants  Cohort follow-up study of children seen between June 2006 and May 2012 at 55 centers. In total, 1724 women (2141 children) were eligible for the study, of whom 1728 children (80.7% of the 2141 eligible children) participated and 1719 children contributed to the primary outcome.

Intervention  Single and multiple courses of antenatal corticosteroid therapy.

Main Outcomes and Measures  The primary outcome was death or survival with a neurodevelopmental disability in 1 of the following domains: neuromotor (nonambulatory cerebral palsy), neurosensory (blindness, deafness, or need for visual/hearing aids), or neurocognitive/neurobehavioral function (abnormal attention, memory, or behavior).

Results  There was no significant difference between the groups in the risk of death or neurodevelopmental disability: 217 of 871 children (24.9%) in the multiple-courses group vs 210 of 848 children (24.8%) in the single-course group (odds ratio, 1.02 [95% CI, 0.81 to 1.29]; P = .84).

Conclusions and Relevance  Multiple courses, compared with a single course, of antenatal corticosteroid therapy did not increase or decrease the risk of death or disability at 5 years of age. Because of a lack of strong conclusive evidence of short-term or long-term benefits, it remains our opinion that multiple courses not be recommended in women with ongoing risk of preterm birth.

Trial Registration  clinicaltrials.gov Identifier: NCT00187382

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Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study 5-Year Follow-up (MACS-5) Trial Profile
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