Obstetrical injuries are a major concern in terms of both patient injury severity and financial impact. One of the more costly injuries is a brachial plexus injury. Fortunately, shoulder dystocia (SD) is a rare complication of vaginal delivery. Furthermore, not every occurrence of SD will result in an injury and/or a malpractice claim. The purpose of this study was to better understand factors that may contribute to medical malpractice claims with SD and to offer recommendations to practicing obstetricians (OBs) regarding the management of SD.
The Doctors Company is the largest physician-owned medical malpractice insurance company in the United States. Our mission is to advance, protect, and reward the practice of good medicine. The Doctors Company studies malpractice claims to better appreciate what motivates patients and their families to pursue claims, to gain a broader overview of system failures and processes that result in patient harm, and to create risk mitigation approaches to improve patient safety.
Characteristics of Claims Studied
A total of 72 cases were reviewed, involving dates of delivery from 2002 to 2016.
- Average patient age 29.14 (17–46) years old; 46% of patients were obese (BMI > 30).
- 75% of patients were multiparous; 6% had a history of previous SD; 14% had previous deliveries of macrosomic newborns (> than 4,000 grams).
- 7% of patients did not speak English.
- 40% of patients were white, 27% were black, 18% were Hispanic, 4% had other ethnicities, and 11% had ethnicities that were unknown.
- 35% of patients had gestational diabetes.
- 49% of patients had an estimated fetal weight (EFW) recorded (average EFW 3335.35 g).
- 18% of patients had both gestational diabetes and obesity.
- 51% of patients had deliveries in teaching hospitals, 49% in non-teaching hospitals.
- 35% of patients were induced.
- 64% of patients had oxytocin, including those who were induced.
- 73% of patients had their primary OB involved in delivery. Six midwives and five residents were involved in the deliveries.
- 72% of patients who had babies over 4,000 g said that vaginal delivery was the wrong choice for delivery, and 38% of those said they had inadequate consent for other treatment options, such as a possible C-section.
- 36% of patients had operative vaginal deliveries (n=20 vacuum, n=3 forceps, and n=3 with both vacuum and forceps).
- Average time to release SD was 2.7 minutes.
The most prevalent contributing factors seen in these claims involved technical, clinical judgment, and communication issues:
- 60% of the claims had a possible technical problem or a known complication.
- 53% of the claims had the clinical judgement factor of proceeding with vaginal birth over cesarean.
- 23% of the claims had improper use of traction during delivery.
- 17% of the claims had inadequate informed consent for other treatment options like a cesarean.
- 4% of the claims contained aspects of insufficient documentation as determined by expert reviews of these 32 cases. In particular, the deficient areas in documentation were related to informed consent on the use of a vacuum and informed consent discussion of the risks/benefits for cesarean birth versus vaginal birth.
A 22-year-old female (G1P0) with family history of diabetes presented to the obstetrician (OB) for prenatal care. She had elevated one-hour glucose at 24 weeks, but the three-hour glucose tolerance test was within normal limits. Following this test, at the next seven prenatal visits, she had glycosuria (range from +1 to +3). At 37 weeks gestation, at her prenatal visit, ketones were found in her urine. There is no documentation of any need for follow-up or discussion of these findings with the mother. Additionally, over the last 15 weeks of the pregnancy, the patient had a 44-pound weight gain, with an overall weight gain of over 63 pounds. An ultrasound was completed at 32 weeks, but the estimated fetal weight (EFW) was not included in the office chart.
At 40 weeks gestation, the patient presented to the hospital in labor. She was seen by a nonprimary OB who had limited access to the prenatal records. Since there was no EFW on the chart, the OB estimated the birth weight at 3,402 g via Leopold maneuvers. The OB did see that the 24-week three-hour glucose tolerance test was within normal limits and did not suspect a large baby. Labor progressed. The mother pushed for four hours, and the OB used a vacuum, then delivered the head with forceps. Shoulder dystocia (SD) was encountered. The OB performed the McRoberts maneuver, applied suprapubic pressure, delivered posterior arm, and disimpacted the anterior shoulder. The infant’s body was delivered in 2 minutes. The infant’s weight was 4678 g, and the infant had a right upper extremity that was floppy. The child required several surgeries and now has permanent mobility issues with the arm.
Takeaways: Clinical experts reviewed this claim and were critical of the documentation.
- Glucose: Clearly, the mother had glucose in her urine for weeks, but whether the OB was aware of this is unknown because of the lack of documentation in the chart. Additionally, there was no indication that the mother was aware of the glycosuria according to her testimony. Often in the routine of the OB office visit, the medical assistant will check the urine sample and write the results on the chart. How these results are communicated to the provider varies from practice to practice. Having a system in place to verify that the results have been seen by the provider can assure that providers are updated.
- Weight gain: The weight gain stated in the claim was also concerning, and once again, the medical record is silent regarding whether the provider was cognizant of this fact, and if so, regarding the clinical plan about it.
- EFW: With the completion of the prenatal ultrasound, the EFW should have been documented in the prenatal records. This habit ensures that the continuity of care is in place for the next OB. Yet, as we discovered, the admitting OB made an estimate of the birth weight when the mother came into the hospital in labor via Leopold maneuvers. The estimate was off by 1,276 g. The patient pushed for four hours, and required the use of a vacuum and forceps. Appropriate decision making can only be attained by having a clear picture of the patient’s status.
- Intrapartum risk factors: Although we lack sufficient data to suggest that the labor curve is a useful predictor of SD, the combination of suspected macrosomia, abnormal labor, and the need for operative vaginal delivery can be a scenario for SD. Abnormal labor can be interpreted as protracted active phase of labor, secondary arrest of labor, or prolonged second stage of labor.
Best Practice Tip: Consider the use of documentation templates. Tools are available that can prompt providers to ask questions, follow the patient more closely, and ensure that documentation of pregnancy abnormalities is complete. A customized template for documentation or a model-type guide for dictation is an excellent, proactive patient safety and risk management tool that can demonstrate the clinical course of labor and delivery and document the measures taken to resolve the SD. The template should include the precise times of the diagnosis of SD and the subsequent times related to the interventions. Identify those present. Clarify their roles and the outcome for both the infant and the mother. Another example: If a patient has gestational diabetes or a concern for it, reminders could be placed to alert the provider for testing and close monitoring. Using a care template improves the quality of care while ensuring adherence with the recommended guidelines. Talk to your electronic medical record (EMR) vendor about these templates for a variety of OB-specific issues.
Best Practice Tip: Create a chronological word picture with labor and delivery documentation. Include any risks for SD. Include the mode of delivery of the infant’s head (spontaneous or operative; presenting position of head; amount and direction of traction, i.e., none, gentle, moderate, or significant). Enter the time of the diagnosis of SD (after delivery of the head) and the time until resolution and delivery of baby’s body. Include in the documentation the maneuvers used and the time implemented, in exact order with results. If there were any assistants, then include when they were present, and what role they played. The infant’s status should include Apgar scores, cord gases, movement of arms, and resuscitation and transfer. The documentation should also include when the pediatrician was called and when the pediatrician arrived. The condition of the mother needs to be included, as well as any explanations provided to the patient and family.
Case Study 1 Reflection
In this study communication emerged as a common theme. Communication issues between both the provider and the patient/family, such as inadequate discussion or informed consent for other treatment options. Communication lacked with providers in the failure to read medical records when the primary OB was not involved in the delivery, including when the most recent medical records were not readily available.
A multiparous patient (G4P3) with a history of gestational diabetes in her previous two pregnancies (vaginal deliveries of infants less than 7 pounds) presented for care to an OB for prenatal care. The patient was obese (BMI 36.4). The OB had a standard prenatal discussion, but did not document any discussion of risk factors associated with obesity and gestational diabetes history. One month later, the patient’s one-hour glucose test came back with an elevated result of 174 mg/dL. This positive screening result was not followed up with a diagnostic test until 31 weeks of gestation, when the patient had a glucose tolerance test. The results showed elevated blood glucose levels both when fasting (99 mg/dL) and for the one-hour glucose test (185 mg/dL). The OB did not have any documentation about the potential for gestational diabetes or a need to check blood sugar. The patient was referred to a diabetes class; however, there is no follow-up documentation reflecting whether or not she attended. At the 36-week appointment, she had a weight gain of 29 pounds. At 39 weeks, the OB noted the mother had excess amniotic fluid, but the OB made no notes about possible fetal macrosomia, or EFW, or the need for a cesarean. A few days later, the mother was admitted for induction. The OB noted the reason for induction was fetal macrosomia (this was the first time that possible macrosomia was mentioned in the notes) and polyhydramnios. The OB documented the fundal height at 44 cm. The mother was started on oxytocin.
The patient had been pushing for over two hours when the OB used vacuum suction to deliver the infant’s head. The McRoberts maneuver was used to deliver the posterior shoulder. The anterior shoulder was accomplished by an episiotomy and suprapubic pressure. The infant weighed 4,677 g. The infant was not moving the left arm and was later diagnosed with multilevel nerve root avulsions from C4–C5 to C7–T1. The child required ulnar nerve transfer and has limited mobility of the arm.
Takeaways: In this case example, multiple missed opportunities for communication were present, according to the clinical experts who reviewed the claim.
- Increased risks: When the patient first came in for prenatal care, the OB should have provided information on the increased risk of macrosomia and SD due to obesity and gestational diabetes.
- Education: Communication could have focused on what to be alert for, what to ask during appointments, and other issues. The mother may have been less vigilant, as she had no other complications with her previous deliveries.
- Concern about large baby: The patient said she had no indication that there was a concern with a large baby or a possibility of the need for a cesarean (this was a debated issue, but the documentation did not support the OB’s stance that the mother was informed of the possibility of a large baby or a possible cesarean).
Best Practice Tip: Provide the informed consent discussion in a calm environment. Take the time to talk with patients about potential complications. This discussion should not be viewed as scaring the patient, but rather informing them. Let them know that complications are rare, but if SD would happen, what to expect. Explain what may happen with the positioning or the pressure on the abdomen with interventions that may be used in SD. Preparing patients for potential complications in a calm, safe environment will decrease the perception that an error has occurred during an actual event.
Best Practice Tip: Review the delivery with the patient and family. Include the previously known risks for SD, the sequence of events at delivery, the actions that were taken during the delivery, and why the actions were done. Be sure the family is aware of your concern and your availability to answer questions later. If possible, attend NICU rounds with the infant’s attending physician to gain information on the injury and to facilitate open communication with the parents of the infant.
Case Study 2 Reflection
In our retrospective review of the mothers with the larger infants (> than 4,000g) data we noted differences in the decision to proceed with the vaginal delivery rather than a cesarean birth. Additionally, there were differences in the communication between the obstetrical provider and the patient/family prenatally.
During prenatal care, a multiparous woman with a history of hypertension and morbid obesity (BMI 42) informed the physicians that she had large babies and had delivered a 12-pound (5443.11 g) baby vaginally. The staff requested but never received her previous medical records. (It was later discovered that the largest baby the mother had delivered was 4,676.68 g, or 10.3 pounds.)
The mother continued to come into the clinic for prenatal care and was typically seen by OB residents. At 28 weeks gestation, she was diagnosed with gestational diabetes. However, it was difficult to contact the mother, and she was not started on medication, home glucose monitoring, and diet recommendations for 4 weeks. She was directed to have an HgbA1C test, but the test was never done, and the clinic did not follow up on this. During the coming clinic visits, the patient said her glucose was under control in the 110 range. However, there were no glucose checks performed at the clinic.
At 36 weeks gestation, there was a marked increase in fundal height, and her urine glucose was +2. At 38 weeks gestation, the fundal height was 45 cm. There was no documentation of potential risks to mother or infant or any discussion of options with the patient. The patient presented to the hospital in labor at 40 weeks gestation. During delivery the resident encountered SD and called for assistance. The resident attempted delivery by McRoberts maneuver without success, followed by an episiotomy and Woods maneuver without success. The attending physician entered as delivery was in progress and called for another attending to assist. The SD exceeded thirty minutes before it was resolved. Apgars were 0, 0, 0. Birth weight was 5,116.31 g. The infant was diagnosed with severe hypoxic-ischemic encephalopathy (HIE) and died the next day.
The experts were critical. In the last four weeks of the pregnancy, there was a rapid discrepancy between the fundal heights, along with +2 glucose in the mother’s urine. But absent in the documentation is any discussion with the patient of these findings, potential risks, or options. This was concerning to the clinical experts reviewing the case, since this pregnancy was her fourth, and infants born from her previous pregnancies all were described as large. She was permitted to progress to 40 weeks gestation. This patient presented with several factors that were high risks: morbid obesity, previous babies >4,000 g, multiparity, and rapid increase in fundal height.
Takeaways: This case presented many opportunities for intervention that may have prevented the outcome. Clinical experts reviewed this claim and were critical. At the top of the list were many systems issues.
- Failure to obtain old medical records: This step was not completed until after the birth of the infant. An earlier examination of those records may have alerted the providers that the patient was a poor historian.
- Inability to contact the patient regarding a new diagnosis: No system was in place to follow up if the patient failed to respond to calls. This failure resulted in the patient not knowing of a new diagnosis of gestational diabetes for over a month and a delay in the start of treatment.
- Lack of clinical correlation: The clinic providers relied on the patient’s statements that the glucose was under control, when a simple finger stick could have been done in the clinic to confirm this.
- Lack of follow-up on missed lab test: There was no system in place to address a missed test, which was an ordered HgbA1C test.
Best Practice Tip: Debrief and collaborative charting. This claim illustrates a situation that occurs often in SD incidents: an unexpected occurrence with multiple people involved. Each provider during the SD is handling their responsibilities and tasks. Evidence has shown that accounts of high-risk events often contain inconsistencies among team members. So once the patients’ condition has stabilized, the team needs to come together and debrief about the event. Discussion should include each provider stating their perception of the event, a confirmation of the timing of the event, and communication regarding what worked well and what can be improved. This debrief of the event can contribute to the team’s documentation to demonstrate the care given.
Best Practice Tip: Consider using standardized checklists to document during emergencies. Standardized checklists can be valuable assets to aid in documentation. The American College of Obstetricians and Gynecologists (ACOG) Committee on Patient Safety and Quality Improvement has recommended these as one tool to help ensure patient safety. A standardized checklist can help ensure documentation of all important areas and can serve as a tool to assist in documenting important times and actions as they occur during a critical event. Checklist development requires planning, training, implementation, and feedback. For more information consult The Use and Development of Checklists in Obstetrics and Gynecology.
Case Study 3 Reflection
Clinical practices must ensure that systems for communication and workflow are effective. For example, having a system to contact a patient quickly with new clinical findings or a system to ascertain that a missed diagnostic test is completed timely are essential. Multiple claims in this study illustrated the negative impact that the failure to implement well-designed systems can have on outcomes.
- Antenatally, evaluate and discuss risk factors for SD. One of most important risk factors to be alert for is a history of previous SD. There are standard lists of risk factors, but certainly obesity, diabetes, and a history of large babies are very important. When there are significant risk factors (including an EFW >4,000 g), a discussion of the risks and benefits of elective cesarean should occur and, according to the judgement of the physician, perhaps be offered.
- Beware of false positive glucose screening. Patients with a positive screening test and a normal glucose tolerance test (GTT) are at risk for adverse outcomes, including SD.
- SD is unpredictable, regardless of the size of the infant. Therefore, hold drills and simulation training for each unit (including physicians) in the management of SD. This training includes communication at the time of the discovery of the SD and debriefing after the incident. This training aims to limit allegations of disorganization and chaos in the delivery room. Evidence supports that this training helps reduce the incidence of brachial plexus injuries through the improvement of team communication, technical skills, documentation, and coordination.
- Since SD is unpredictable, ensure all providers on your team are well-trained to manage it with the appropriate maneuvers. For guidance, consult the website of the American College of Obstetricians and Gynecologists (ACOG) (acog.org).
- Help nurses understand their role in management of SD. This instruction includes how to perform the McRoberts maneuver, apply suprapubic pressure, and record times. Place a foot stool in every delivery room to assist nurses with giving suprapubic pressure.
- To strengthen the patient’s and family’s understanding of the necessary interventions, involve the patient and her family in decision making as much as possible during the labor process. Document this discussion. Reinforce the informed consent as the need for manual manipulation techniques or cesarean section becomes evident.
- Recognize that operative vaginal delivery is a risk factor. The use of sequential instruments (vacuum and forceps or vice versa) is associated with a significant increase in neonatal morbidity.
- Learn how to communicate with patients when there is an adverse outcome. For physicians, knowing how to apologize, accept anger, follow up, visit the NICU, etc. is important, even though a suit may not be prevented. The use of empathetic statements, such as “I am going to do all I can to find out why this happened, and I will keep you informed about what I learn,” is essential to assure good communication. It may help to read some examples of empathetic and nonempathetic statements.
- Consider utilizing a documentation template to help capture every aspect of the SD delivery. Documentation is critically important.
- Document the EFW as part of the admitting physical examination for every patient. In this analysis, only 35 of the 72 claims had the EFW documented. Although EFW is not always accurate, it can be defended when documented; otherwise, it can appear that the estimation of fetal weight was never done. Showing that the EFW was done (and documented) indicates that the practitioner likely went through the mental process of considering whether a vaginal birth was a reasonable option.
- Give attention to potential race and ethnicity risk factors. Although they were not a significant finding in this analysis, they are worthy of consideration. A 2017 study examined over 19,000 deliveries in five locations and illustrated risk factors associated with SD in racial/ethnic groups. Having an epidural with labor (OR=4.4) and/or delivering past 40 weeks (OR=2.4) were strong risk factors for white non-Hispanics. Using insulin to manage gestational diabetes (OR=4.6) and/or having an epidural with labor (OR=5.3) were risk factors for black non-Hispanics. Hispanic mothers had a strong risk factor when Spanish was their primary language (OR=2.3).
This study has several limitations. First, this analysis was a review of medical legal cases involving SD claims that resulted in injuries. The claims came from closed malpractice claims from one large national insurer, and do not represent all closed malpractice claims in the United States.
Additionally, in the use of malpractice claims, there was no comparison to any information on SD cases that did not proceed to a claim being filed. This limitation is especially significant since not all SD cases result in injury.
Some information was not consistently available in the records for a more detailed examination of the claims regarding management. Lack of documentation affected the ability to fully analyze SD. These restraints included dependable information on which shoulder presented, what maneuvers were performed, and in what order they were completed.
SD is unpredictable and can occur even with the most experienced practitioner; therefore, a memorized, well-orchestrated plan of action is necessary to help prevent complications that could lead to brachial plexus injury, brain damage, or death. While the presence of risk factors cannot truly predict SD, the first step toward loss prevention is an accurate prenatal assessment to identify patients who may be at risk. Identifying the at-risk patient, predicated on timely and complete prenatal assessments, should cause the physician to closely monitor the patient’s labor progression for indications of difficulty. The need for clear, concise documentation, teamwork, and patient communication are recurring themes in these SD claims. Our goal is to decrease and prevent future SD and brachial plexus injuries.