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Related Experiment Videos

Chorionic villus sampling and rare side-effects: will a randomised controlled trial detect them?

R W Orrell1, R J Lilford

  • 1Department of Obstetrics and Gynaecology, St. James's University Hospital, Leeds, UK.

International Journal of Gynaecology and Obstetrics: the Official Organ of the International Federation of Gynaecology and Obstetrics
|May 1, 1990
PubMed
Summary

This study details a stillbirth after chorionic villus sampling (CVS), highlighting the need for larger trials. Current studies are too small to detect rare but serious complications of CVS and amniocentesis.

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Area of Science:

  • Perinatal medicine
  • Reproductive genetics

Background:

  • Chorionic villus sampling (CVS) and amniocentesis are common prenatal diagnostic procedures.
  • Research comparing CVS and amniocentesis primarily focuses on miscarriage rates.
  • Larger sample sizes are required for statistically powerful comparisons of rarer complications.

Purpose of the Study:

  • To calculate the sample size needed to detect significant differences in rare complications between CVS and amniocentesis.
  • To evaluate the adequacy of current trial sizes for assessing obstetric and neonatal outcomes.

Main Methods:

  • Case report of stillbirth following CVS.
  • Statistical calculation of required sample sizes for detecting differences in complication rates.
  • Review of existing controlled trials comparing CVS and amniocentesis.

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Main Results:

  • A case of stillbirth attributed to massive placental abruption post-CVS is presented.
  • Calculations indicate that extremely large sample sizes are necessary to detect rare but significant complications.
  • Existing trials are underpowered to identify important differences in late obstetric, neonatal, or long-term complications.

Conclusions:

  • Current controlled trials are insufficient to assess the safety of CVS versus amniocentesis regarding rare adverse events.
  • Larger, more powerful studies are needed to fully understand the risks associated with these invasive prenatal diagnostic procedures.
  • The potential for serious complications, though rare, necessitates careful consideration of trial design and sample size.