title: 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.
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
  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).
  
  
  CONCLUSIONS
  Data analyses are expected to commence in 2011 with results publicly available in 2012.
authors.affiliation: 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. caroline.crowther@adelaide.edu.au
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Crowther
authors.forename: Fariba
authors.initials: F
authors.lastname: Aghajafari
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Askie
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Asztalos
authors.forename: Peter
authors.initials: P
authors.lastname: Brocklehurst
authors.forename: Tanya K
authors.initials: TK
authors.lastname: Bubner
authors.forename: Lex W
authors.initials: LW
authors.lastname: Doyle
authors.forename: Sourabh
authors.initials: S
authors.lastname: Dutta
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Garite
authors.forename: Debra A
authors.initials: DA
authors.lastname: Guinn
authors.forename: Mikko
authors.initials: M
authors.lastname: Hallman
authors.forename: Mary E
authors.initials: ME
authors.lastname: Hannah
authors.forename: Pollyanna
authors.initials: P
authors.lastname: Hardy
authors.forename: Kimberly
authors.initials: K
authors.lastname: Maurel
authors.forename: Premasish
authors.initials: P
authors.lastname: Mazumder
authors.forename: Cindy
authors.initials: C
authors.lastname: McEvoy
authors.forename: Philippa F
authors.initials: PF
authors.lastname: Middleton
authors.forename: Kellie E
authors.initials: KE
authors.lastname: Murphy
authors.forename: Outi M
authors.initials: OM
authors.lastname: Peltoniemi
authors.forename: Dawn
authors.initials: D
authors.lastname: Peters
authors.forename: Lisa
authors.initials: L
authors.lastname: Sullivan
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Thom
authors.forename: Merryn
authors.initials: M
authors.lastname: Voysey
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Wapner
authors.forename: Lisa
authors.initials: L
authors.lastname: Yelland
authors.forename: Sasha
authors.initials: S
authors.lastname: Zhang
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000517:prevention & control*; D012307:Risk Factors; D000078202:Systematic Reviews as Topic; D015201:Meta-Analysis as Topic
chemical_list: D000305:Adrenal Cortex Hormones