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Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol

Caroline A Crowther1*, Fariba Aghajafari2, Lisa M Askie3, Elizabeth V Asztalos4, Peter Brocklehurst5, Tanya K Bubner1, Lex W Doyle6, Sourabh Dutta7, Thomas J Garite8, Debra A Guinn9, Mikko Hallman10, Mary E Hannah11, Pollyanna Hardy5, Kimberly Maurel8, Premasish Mazumder12, Cindy McEvoy13, Philippa F Middleton1, Kellie E Murphy11, Outi M Peltoniemi10, Dawn Peters14, Lisa Sullivan15, Elizabeth A Thom16, Merryn Voysey17, Ronald J Wapner18, Lisa Yelland1 and Sasha Zhang1

Author Affiliations

1 Australian Research Centre for Health of Women and Babies (ARCH), Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, Adelaide, Australia

2 Faculty of Medicine, University of Calgary, Calgary, Canada

3 National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia

4 Department of Paediatrics and Obstetrics/Gynaecology, University of Toronto, Toronto, Canada

5 National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK

6 Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia

7 Department of Neonatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India

8 Pediatrix Medical Group, Sunrise, USA

9 Northwest Perinatal Centre, Portland, USA

10 Department of Paediatrics, University of Oulu, Oulu, Finland

11 Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada

12 Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India

13 Department of Pediatrics, Oregon Health and Science University, Portland, USA

14 Public Health and Preventive Medicine, Oregon Health and Science University, Portland, USA

15 School of Public Health, Boston University, Boston, USA

16 The Biostatistics Centre, George Washington University, Washington DC, USA

17 Centre for Statistics in Medicine, University of Oxford, Oxford, UK

18 Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Columbia University Medical Centre, New York, USA

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Systematic Reviews 2012, 1:12  doi:10.1186/2046-4053-1-12

Published: 12 February 2012

Abstract

Background

The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.

Methods/Design

The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).

Discussion

Data analyses are expected to commence in 2011 with results publicly available in 2012.