Medicolegal Issues

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

Author and Disclosure Information

Don’t accommodate plaintiff’s attorneys who have reinvented an intended guideline as a requirement!


 

References

The authors report no financial relationships relevant to this article.

CASE: Primigravida with ruptured membranes

A 21-year-old patient was admitted to the labor and delivery suite in active labor. After a reassuring fetal tracing was documented, active management with oxytocin was initiated.

Five hours later, the nurse noted a prolonged deceleration.

Resuscitative efforts failed to alleviate the deceleration. The nurse notified the attending OB of the situation. An emergency cesarean section was called because:

  1. of a nonreassuring fetal heart rate tracing and
  2. delivery was not imminent.
Now, the attending leaves her home promptly to perform the cesarean section; the anesthesiologist, who is not in the hospital, is notified.

The team is assembled and the patient is moved to the operating room; 34 minutes have elapsed between the time the decision was made to perform the cesarean section and the time the incision is made on the abdomen.

Two minutes later, the baby is delivered. Apgar scores are as follows: 0 at 1 minute; 0 at 5 minutes; 0 at 10 minutes; and 1 at 15 minutes.

Subsequently, the baby is determined to be severely brain-damaged. The parents file a claim of malpractice.

ObGyns have come to depend on ACOG’s Committee Opinions, Educational Bulletins, Practice Bulletins, Policy Statements, and Technology Assessments to help us take the best care of our patients. To quote the College, each of these documents “is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued appropriateness to practice.”1

Sometimes, however, an ACOG bulletin, statement, or assessment may be misinterpreted and can actually contribute to some of the medicolegal problems that we face. The actual clinical situation just described, relating to ACOG’s statement on the so-called decision-to-incision gold standard, is a case in point.

The parties in the case go to trial

During the subsequent trial, the plaintiff alleges negligence by claiming that the defendant:

  • did not anticipate or recognize developing fetal problems
  • failed to perform a C-section within 30 minutes after the decision was made to do so.
The defendant counters:
  • There was no fetal indication of hypoxia or cause for concern until the fetal bradycardia was noted
  • Brain damage was caused by an unanticipated event that occurred more than 30 minutes before delivery
  • The team responded as rapidly as it could given the circumstances of the hospital and staffing patterns.
No verdict was reached; instead, the parties agreed to a multimillion-dollar settlement that is based on 1) more than 30 minutes having elapsed from “decision to incision” and 2) the assertion that a 30-minute decision-to-incision time is the standard of care for an emergency C-section.

Are we held to a standard that can’t be met and has no basis in evidence?

To repeat, as reported in hospital records admitted into evidence at trial, the baby was delivered, with a low Apgar score, 34 minutes after the decision was called. The fact that the incision commenced after more than 30 minutes was a major factor contributing to the multimillion-dollar settlement.

That 30-minute mark is taken directly from the fifth edition of ACOG’s Guideline for Perinatal Care:

Any hospital providing obstetric service should have the capability of responding to an obstetric emergency. No data correlate the timing of intervention with outcome, and there is little likelihood that any will be obtained. However, in general, the consensus has been that hospitals should have the capability of beginning a cesarean section within 30 minutes of the decision to operate.2

The interpretation that all C-sections must be performed within 30 minutes of a decision is challenged by a recent study sponsored by The National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network.3 The design of that study was observational, because no ethical means exist to randomize women to less than or more than 30 minutes from the time of a decision to perform a C-section to the time of the incision.

The data collected came only from primagravid women in active labor who had an infant that had a birth weight of more than 2,500 g. Indications for C-section included: nonreassuring fetal heart rate, umbilical cord prolapse, placental abruption, placenta previa with hemorrhage, and uterine rupture. A total of 11,481 cases were analyzed over a 2-year period, with 2,808 C-sections performed for those indications (a 24.5% rate of C-section). Ninety-four per cent of the C-sections were undertaken because of a nonreassuring fetal heart rate.

Next Article: