Epidemiology of recent perinatal trials in Australia

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 (n15)
• 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

• gt 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

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Amount of funding

• 4/41 studies gt 1 million
• But mostly under 500,000
• Missing data for gt 50 studies

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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 (n18))
• 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?