Medicolegal Issues

There is no gold standard for decision-to-incision time

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References

In a university setting, where one would expect in-house OB coverage and anesthesia to be available, only 65% of emergency C-sections commenced within 30 minutes of a decision (17% in less than 10 minutes; 27% in less than 20 minutes). Investigators also found that, in cases in which a C-section was performed for a nonreassuring fetal heart rate, only 62% were performed in fewer than 30 minutes.

The data are clear: More than one third of all C-sections for these indications did not comply with the “30-minute rule.”

Notably, the study also found that:

  • when the decision-to-incision time was less than 30 minutes, the rates of fetal acidemia and intubation in the delivery room were higher
  • 95% of infants delivered in more than 31 minutes did not experience any of the adverse outcomes listed in the accompanying TABLE
  • only one of eight neonatal deaths occurred in the group of infants delivered after 31 minutes (at 33 minutes).
The investigators also found that decision-to-incision time had no impact on maternal complications.

TABLE

Outcomes are no better when the decision-to-incision time is less than 30 minutes3

OUTCOMEINCIDENCE AT INCIDENCE AT >30 MIN
Urine pH, 4.8%1.6%*
Intubation in delivery3.1%1.3%*
Hypoxic–ischemic encephalopathy0.7%0.5%
Fetal death0.2%0%
Neonatal death0.4%0.2%
Apgar score at 5 min, 1.0%0.9%
None of the above92.6%95.4%*
*P <.05>

30 minutes? It’s not a mandate

The study supported by NICHD shows that:

  • the decision-to-incision interval appears to have no impact on maternal complications
  • an infant delivered within 30 minutes for an emergency indication was more likely to be acidemic and to require intubation than an infant delivered in longer than 30 minutes for an emergency indication
  • delivery within 30 minutes does not guarantee that there will be no adverse outcome
  • 95% of infants delivered in more than 30 minutes did not have compromise.
Where did it originate? These facts make us wonder: How did the controversial, seemingly random time of 30 minutes crawl into the courtroom and become a benchmark? Why have attorneys and expert witnesses for the plaintiff taken this 30-minute rule to be fact?

The ACOG guideline is, as stated, clearly not a requirement. It does not mandate that all C-sections commence within 30 minutes from the time of the decision to perform one. Rather, the guideline clearly states that the hospital should be capable of performing the procedure within 30 minutes.

To be clear, we are not advocating a guideline or policy of waiting to perform a C-section! We believe rapid delivery is proper. But the optimal time, or even minimal time, to delivery has not been defined by data—and may never be.

What should it really mean? Thirty minutes, therefore, should be a goal, not a finite time. Data published by NICHD should now be used to temper notions that exceeding the so-called 30-minute rule necessarily 1) is an indicator of substandard care and 2) has adverse effects on outcome for the newborn.

Perhaps it’s time for ACOG to review these recent data and then reaffirm, replace, or withdraw the statement from the perinatal guidelines proposing that 30 minutes be the maximum time from decision to incision.1

Here’s what you should do until the matter is clarified

If you must defend yourself against an accusation of not having performed a C-section in a timely fashion, data from the NICHD Perinatal Collaborative may offer a helpful defense. Because 38% of C-sections for a nonreassuring fetal heart rate tracing are not performed within 30 minutes of a decision to proceed, even in a university setting, this cannot be considered a standard and not meeting this arbitrary time should be looked on as a frequent occurrence.

Based on current data, therefore, any medicolegal case in which the plaintiff’s attorney implies that failure to conform to this putative standard resulted in a bad outcome should be defended vigorously—and should not be settled.

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