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ProAssurance Risk ManagementMay 20255 min read

Lack of Documented Informed Consent Critical in Shoulder Dystocia and Infant Death Case

Lack of Documented Informed Consent Critical in Shoulder Dystocia and Infant Death Case
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This case study presents a closed claim involving a failure to document discussions of the risks, benefits, and alternatives of vaginal delivery with a patient who had a constellation of shoulder dystocia risk factors.

Allegation

The defendants failed to inform the mother of the risks of vaginal delivery with probable fetal macrosomia and failed to timely and correctly perform the maneuvers to relieve the shoulder dystocia.

Case Details

On August 23, a primigravida, 270 lb., 64 in. tall patient (BMI 46) presented to a clinic following a positive home pregnancy test. Her estimated delivery was April 6. She was seen regularly at the clinic for prenatal care. During her pregnancy she gained 75 lb. Her blood sugar hovered around 120. She was referred to a gestational diabetes program for nutritional counseling, both for her borderline gestational diabetes and excessive weight gain.

On March 1, the clinic sent the patient’s prenatal record to the hospital where she planned to deliver. On March 20 (37 weeks) she had an ultrasound. The report noted a borderline macrosomic infant (4960g) with a head to abdominal circumference (HC/AC) ratio of 0.8. The radiologist commented in the report impression section, “This is a very large patient and most of the fetal structures were difficult to see.” The clinic did not send the ultrasound report to the hospital.

At her March 28 (38 weeks) prenatal appointment, the patient was scheduled for a repeat ultrasound the following week due to concerns for fetal macrosomia. However, prior to the ultrasound, the patient presented to the hospital in active labor. The ob-gyn who had been managing her prenatal care came to the hospital to examine her, but the patient refused his care. Therefore, the patient was managed by the on-call ob-gyn, who was not affiliated with the clinic, and had no knowledge of the patient’s prenatal course. The hospital chart the on-call ob-gyn had access to did not include the ultrasound report from the clinic or any prenatal records created after March 1. The prenatal ob-gyn did not inform the on-call ob-gyn that he suspected fetal macrosomia.

The maternal patient had a prolonged labor. Delivery of the head was accomplished with a vacuum, but then a severe shoulder dystocia was encountered. Standard techniques failed to deliver the impacted shoulder. An emergency C-section was called. After performing the Zavanelli maneuver two times to get the infant’s head back into the uterus, the 12 lb. infant was delivered. He was blue/dusky, without heart rate, respiratory effort, movement, or muscle tone. Resuscitation efforts were not successful.

The parents of the deceased infant sued the prenatal care and labor and delivery teams. In her deposition, the maternal patient testified she was not counseled about her weight or her diet and denied she was told she had gained too much weight or that the baby was unusually large. Instead, she recalled being told the fetal weight estimate was six to seven pounds. Although she expressed her preference for a vaginal delivery over C-section when it was offered during labor, she denied being informed of any risks associated with proceeding with a vaginal delivery.

There was no documentation in either the clinic or hospital chart of a discussion of the risks of vaginal delivery with the mother’s constellation of risk factors for shoulder dystocia. There was similarly no documentation of the reasoning that supported use of a vacuum.

Expert Testimony

According to experts, the “greatest weakness” for the prenatal team was the lack of evidence of an informed consent discussion about delivery options given the maternal patient’s shoulder dystocia risk factors (short stature, weight gain during pregnancy, high BMI, and elevated blood glucose levels). They noted that the mother should have particularly been advised that significant weight gain and elevation of her blood glucose levels during pregnancy put her at increased risk.

The plaintiff’s experts could argue that the HC/AC ratio of 0.8 from the ultrasound and the high estimated fetal weight presented additional risk factors for shoulder dystocia. Alternatively, they could argue due to the patient’s body habitus, ultrasounds would be inaccurate (an issue raised by the radiologist who interpreted the ultrasound). Thus, arguments put forward by the defense that the estimated fetal weight was below the threshold for a finding of fetal macrosomia, could be unpersuasive.

Experts were also critical of the on-call ob-gyn for her failure to document a plan that adequately accounted for the risk of shoulder dystocia; discuss the risks, benefits and alternatives of continuing vaginal delivery; and call for a C-section at an earlier point.

Resolution

The decision to settle this case was based on various issues. Defense expert support was not available and evidence of an informed consent was absent. Further, the state in which this case was litigated recognizes the right to recover for pre-death pain and suffering, which the graphic nature of the delivery could support.

Risk Reduction Strategies

When managing the prenatal care or labor and delivery of a patient at risk for shoulder dystocia consider the following strategies:

  • Engage in a thorough informed consent discussion, early and often, including a comparison of the risks and benefits of both vaginal delivery and C-section based on the patient’s characteristics.
  • Ensure that the patient understands her behavior’s impact on the well-being of her unborn child, particularly excessive weight gain and failure to control gestational diabetes.
  • Offer and request as much information about the patient’s prenatal course and studies that might not have been captured in the labor and delivery hospital record during handoff between prenatal and labor and delivery teams.
  • Engage in discussions about the risks, benefits, and alternatives of different delivery options early in labor, and when delivery recommendations change.
  • Be particularly sensitive to the possibility that an obese maternal patient may require a more robust informed consent process.
  • Adequately document all informed consent discussions, and document how you ensured the patient understood those risks.
Conclusion

Even though a patient’s weight can be a tricky discussion topic, it is important for a maternal patient to adequately understand the potential risks her behavior can have on her unborn child. Educating a patient about how her particular characteristics can complicate labor and delivery provides the groundwork for informed decision making about delivery options. Documentation in the medical record is the most reliable evidence of appropriate patient education and informed consent.

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If you have questions on this topic, please contact us at RiskAdvisor@ProAssurance.com or 844-223-9648.

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ProAssurance Risk Management
The ProAssurance Risk Management department is here to help you promote patient safety, minimize risk, and improve defensibility of claims by providing comprehensive assessment and training resources that are relevant and easy to share. If you have a question you would like to discuss with a risk consultant, email RiskAdvisor@ProAssurance.com or call 844-223-9648.

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