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Perinatal clinical epidemiology

A Ohlsson1, J Lacy

  • 1Women's College Hospital, Toronto, Ontario, Canada.

Current Opinion in Pediatrics
|April 1, 1993
PubMed
Summary
This summary is machine-generated.

Many perinatal trials assessing antenatal interventions for neonatal outcomes lack sufficient sample sizes. Realistic event rate differences are needed to demonstrate effectiveness, often requiring multicenter collaboration.

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Area of Science:

  • Perinatal medicine
  • Neonatal outcomes research
  • Clinical trial methodology

Background:

  • A review of 19 perinatal trials published between 1991-1992 was conducted.
  • Trials focused on antenatal interventions assessed by neonatal outcomes.

Purpose of the Study:

  • To evaluate the quality and findings of recent perinatal trials.
  • To identify limitations in study design and sample size calculations.

Main Methods:

  • Literature search of multiple databases and personal files.
  • Quality assessment of included studies using a scoring system.
  • Analysis of primary outcome measures and statistical significance.

Main Results:

  • Quality scores varied widely (0.25-0.80).

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  • Most trials failed to show statistically significant changes due to overestimated treatment effects.
  • Individual trials were insufficient to determine the balance of benefits and harms.

    • Conclusions:

    • Overestimated treatment effects led to inadequate sample sizes, potentially overlooking clinically important findings.
    • Future research requires realistic event rate differences for sample size calculations.
    • Multicenter trials with national and international cooperation are necessary to demonstrate the effectiveness of perinatal interventions.