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Epidemiology of recent perinatal trials in Australia

Epidemiology of recent perinatal trials in Australia. Philippa Middleton for the WOMBAT Collaboration ( Wom en and B abies Wellbeing: A ction through T rials) PSANZ 2006. Aim of this study. To document perinatal trial activity in Australia To contribute to baseline measurements for WOMBAT

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Epidemiology of recent perinatal trials in Australia

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  1. Epidemiology of recent perinatal trials in Australia Philippa Middleton for the WOMBAT Collaboration (Women and Babies Wellbeing: Action through Trials) PSANZ 2006

  2. Aim of this study • To document perinatal trial activity in Australia • To contribute to baseline measurements for WOMBAT • To highlight priority tasks for WOMBAT

  3. Methods • National and international trials registries • Research grant databases (NHMRC) • Selected the perinatal trials (generally from 2000 on) • Extracted data such as topic, funding, number of recruits

  4. 100 perinatal trialsrecruiting or recently completed • 43 currently recruiting (or not yet recruiting/in development) • 52 closed to accrual • publications located for 25 • 1 trial stopped • 5 no details of status

  5. Trial topic • Preterm (n=15) • Respiratory /lung • Pain • Mode of birth • Breastfeeding • Infection

  6. Type of intervention • Drugs, vitamins or supplements • Procedures • Care/policy • Devices • Education

  7. Multicentre • 47 single centre • 48 multicentre • 18 of these international • 5 no details

  8. Main centre • Victoria, NSW and SA 25% each • Remainder WA, Qld, international sites

  9. Planned recruitment size • > 2,000 recruits (DOMINO, Maternal posturing trial) • Median: 100 to 500

  10. Funding sources Information for 65/100 studies • 35/65 (54%) funded by NHMRC • 25/35 (71%) solely NHMRC • 6 philanthropic • 7 professional bodies

  11. Amount of funding • 4/41 studies > $1 million • But mostly under $500,000 • Missing data for > 50% studies

  12. Time to publication (from close of accrual) 25 of these trials published since about 2000 Typically 2 to 3 years from close of accrual

  13. Summary and comments (1) • About 60 ‘active’ perinatal trials – 40 recruiting, 20 in follow-up/preparing publication • About half the trials are multicentre (1/3 international (n=18)) • Is median 100 to 500 large enough?

  14. Summary and comments (2) • Missing information – ACTR will assist • NHMRC funds half the trials • Most $0.5 million or less • Potential for other funding sources? • Potential for more multicentre/international trials?

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