Concern over the nation’s rising rate of maternal injury and death has prompted The Doctors Company to review closed claims to identify potential sources of patient injury and provide tools for enhancing safety in ob/gyn, known to be a high-risk specialty.
Of 11,289 total claims and suits closed and coded between 2013 and 2017, 490 were obstetric related. Maternal injury accounted for 94, or 19.2 percent, of the obstetric claims. The remainder were neonatal injuries.
Though they make up just less than a fifth of obstetric claims, maternal injury claims were important to study because about 700 women die from complications related to childbirth in the U.S. each year, according to data from the Centers for Disease Control and Prevention.
700 women die from complications related to childbirth in the U.S. each year.
Maternal deaths also occur more often in the U.S. than in many other developed countries—a rate of 26.4 per 100,000 live births. The rate is 9 per 100,000 in Germany, 8.8 in the United Kingdom, 7.8 in France, 7.3 in Canada, and 6.4 in Japan.
Our research showed that 38 percent of maternal injury claims resulted in settlements or judgments—much greater than the average number of paid claims for other physician specialties like general surgery (28 percent), internal medicine (27 percent), and gynecology (31 percent).
We found that two of the most common diagnoses resulting in claims were postpartum hemorrhage, accounting for 15 percent of maternal injury claims, and preeclampsia/eclampsia, making up 9 percent.
Postpartum hemorrhage accounted for 15 percent of maternal injury claims, and preeclampsia/eclampsia accounted for 9 percent of claims.
The rest of the maternal injury claims included these diagnoses:
- Disruption of the perineal wound or complication of a surgical wound: 9 percent
- Placenta previa, placental separation, antepartum hemorrhage: 7 percent
- Tubal pregnancy, ectopic pregnancy: 6 percent
- Maternal cardiovascular disease, cardiovascular disorder, puerperium and postpartum cardiomyopathy: 6 percent
- Spontaneous abortion (no complication and with infection) and incomplete abortion with infection: 5 percent
- Intrauterine death: 5 percent
- Trauma to pelvic organs: 5 percent
- Amniotic fluid embolism: 4 percent
- Perineal laceration: 3 percent
- Infection of the amniotic cavity: 2 percent
- Rupture of the uterus during labor: 2 percent
- Miscellaneous complications: 2 percent
In our closed claims study, we focused on postpartum hemorrhage and preeclampsia/eclampsia because of the high percentage of these claims that resulted in serious injury or death.
Postpartum Hemorrhage Closed Claims
In claims with a final diagnosis of postpartum hemorrhage, injuries included:
Since operative deliveries can include vaginal deliveries with the use of forceps or vacuum extraction, as well as cesarean sections, patients may assume that those techniques caused or contributed to the hemorrhage, when in many cases that is not so. So, the allegations in a liability case are not always helpful in understanding what happened.
Therefore, we use physician reviewers to help us understand the factors that lead to patient injury. In the hemorrhage claims, these experts found that three out of every four claims with a technical performance factor (53 percent) were due to complications and not due to negligence. Only a quarter of the claims with this factor were due to substandard care.
Selection and management of therapy was a factor in 47 percent of maternal injury claims. (More than one factor can lead to an injury.) This often refers to a delay in recognizing a problem and taking the necessary steps to correct it.
Selection and management of therapy was a factor in 47 percent of maternal injury claims. This often refers to a delay in recognizing a problem and taking the necessary steps to correct it.
The cause of a hemorrhage is not always known, but if there is negligence it is most likely to involve a delay in recognition and intervention. Additional factors contributing to patient injury from hemorrhage include conditions affecting the caregiver, such as distractions, multitasking, and interruptions. Those were a factor in 20 percent of the claims.
Staff issues, such as those involving physician coverage, were a factor in 13 percent of injuries.
Staff issues, such as those involving physician coverage, were a factor in 13 percent of injuries.
Postpartum Hemorrhage Case Studies
Consider these examples in which postpartum hemorrhage might have been addressed more effectively:
Case Study 1
The patient presented to labor and delivery when her water broke. The baby was delivered by cesarean section. The uterus was bleeding, so areas were cauterized, and the incision was closed.
The patient continued to bleed with a boggy uterus. Nurses performed uterine massage, administered Methergine, and applied pressure dressing. The patient became hypotensive and tachycardic. The patient was given several units of blood.
Six hours after delivery, a balloon was inserted for tamponade. Bleeding continued, however, and the patient expired 15 hours later.
Most experts agreed that the response to this crisis was insufficient. The amount of blood loss was not measured. By the time the extent of the crisis was recognized, the patient was seriously ill, and the interventions were too late.
Case Study 2
The patient was found to have a low-lying placenta, anterior, which increased the risk of accreta. The obstetrician discussed with the patient the possibility of hemorrhage that could occur at delivery and result in a hysterectomy.
The patient underwent a cesarean section. The uterus was normal in appearance and the placenta was removed manually. The patient did not bleed as expected.
The patient had a normal recovery and was discharged on post-op day three. There were no signs of vaginal bleeding. The patient attended her post-op appointment two weeks following her discharge from the hospital.
About three weeks postpartum, the patient presented to the emergency department with complaints of active vaginal bleeding. Attempts were made to examine the patient, but she was bleeding profusely. She underwent an emergency hysterectomy, but did recover.
Experts expressed differing opinions. Plaintiff experts claimed that the obstetrician failed to remove all the placenta from the uterus, causing a postpartum hemorrhage. Defense experts disagreed, stating that products of conception would have caused cramping and bleeding following delivery. Their successful argument described a rare condition called subinvolution of the placental site as the cause of the bleeding.
Preeclampsia and Eclampsia Closed Claims
In claims with a final diagnosis of preeclampsia or eclampsia, injuries included:
Patient assessment issues, such as failure to establish a differential diagnosis or to appreciate and reconcile relevant signs, symptoms, and test results, were factors that led to injury in 67 percent of these closed claims. Patients frequently will present with a headache that is often an indicator of high blood pressure that should be treated expeditiously. The longer the delay, the more likely the patient will suffer a stroke or other injury from the excessive pressure.
However, a patient may report headaches to a primary care or emergency physician rather than her obstetrician, not realizing the connection and possible threat to the pregnancy. Ideally, the treating physician will report this concern to the obstetrician, but in some cases the headache is treated but not the high blood pressure.
Communication among providers was a contributing factor in 56 percent of the cases. This often involves failure in communication between nurses and physicians, which can take several different forms. A nurse may take a patient's blood pressure, note that it is high, but get called away and distracted before reporting this critical value to the physician. Or the nurse may call the physician with that information, but the doctor does not communicate treatment instructions to the nurse or another physician who is present.
Communication among providers was a contributing factor in 56 percent of the cases.
Off-hours conditions for providers working on weekends and holidays were found to be contributing factors in 33 percent of the closed claims. Staffing may be limited during off-hours, and if there is not an adequate policy and process for calling in additional help, patients with elevated blood pressure or preeclampsia may go longer than normal without being treated. Selection and management of therapy also was found to be a factor in 33 percent of cases including management of pregnancy and failure to order medication.
Off-hours conditions for providers working on weekends and holidays were found to be contributing factors in 33 percent of the closed claims.
Preeclampsia and Eclampsia Case Studies
Case Study 1
Over the course of two months, a pregnant patient had increasingly elevated blood pressures and increasing amounts of protein in her urine. She also developed headache and was prescribed bedrest.
The patient’s symptoms did not improve, so an obstetrician recommended induction. The nurse midwife communicated the recommendation to the patient without explaining the clinical rationale. The patient declined. The nurse midwife did not communicate this information to the obstetrician. The following day, the extremely elevated results of the patient’s 24-hour urine protein were received.
A short time later, the patient presented to the emergency department with severe abdominal pain. Her blood pressure was 197/111. The patient was admitted and taken for a cesarean section.
Following the delivery, the patient’s blood pressure remained elevated. Attempts to reach the physician were unsuccessful. A few hours later the patient vomited. A short time after that she was found unresponsive. A CT scan showed intracranial bleeding. The patient expired later that evening.
Experts opined that the patient should have been delivered earlier due to the protein in her urine. Clinicians were also criticized for not investigating the causes of headache. The risks of delaying delivery were not explained to the patient. Experts expressed concerns about the patient’s postpartum management and the failure of nurses to have a physician evaluate the patient when her pressures remained so high after delivery.
Case Study 2
The patient had a cesarean section and two days later was discharged with a normal blood pressure reading. Eight days later, she presented to the emergency department with a severe headache and elevated blood pressure (172/104). She was treated with a pain reliever and discharged when the pain decreased.
Four days later, the patient met with her obstetrician complaining of continuing headache. Her blood pressure was still elevated. Her physician ordered medications for elevated blood pressure and headache. Lab results showed elevated uric acid and normal liver enzymes. No urine protein was ordered.
After another four days, the patient presented to the emergency department complaining of severe headache and slurred speech. Her blood pressure remained elevated (183/97). A CT scan showed hypodense areas in her cerebellum. She was diagnosed with postpartum eclampsia and vasospasm.
The patient was admitted to the ICU, where her condition continued to deteriorate. She slipped into a coma and expired.
Experts differed on the patient’s diagnosis and a recommended treatment modality. Even with differing opinions, it was clear that multiple clinicians failed to take definitive action to reduce the patient’s blood pressure and prevent the cerebrovascular accident.
Accurate blood loss assessment: In some of the hemorrhage cases, patients were observed having continued bleeding after delivery, but the measures taken were not adequate. It was clear that in many cases the nurses and physicians providing care did not recognize the extent of the bleeding soon enough. A contributing factor was that blood was absorbed in blankets and towels so that it was difficult to quantify unless those items were weighed before and after blood absorption. It is only from accurately assessing the blood loss that clinicians can recognize the problem early and intervene in the most effective manner. Routinely weighing blood-absorbent materials is the standard of care, yet many institutions do not follow this practice, and instead wait until clinicians perceive excessive blood loss.
Communication: Timely communication among clinicians is essential for early interventions. Closed-loop communication confirms that both parties share understanding of the situation, which increases the chances of an adequate response to patients’ crises.
Communication between clinicians and patients and their families is also crucial. Some maternal injuries are unavoidable with the best of care, and regardless of the cause, physicians and hospitals should communicate openly with patients who suffer unexpected outcomes. Honesty is important, and that includes explaining the results of internal investigations. Even when the care provided was appropriate, physicians and hospitals must take the time to help patients understand what happened. When negligence has caused patient harm, physicians and healthcare organizations are usually willing to negotiate settlements and provide compensation.
Risk Mitigation Strategies
To prevent maternal injury and death, we recommend that healthcare providers and hospitals consider the following steps:
- Adopt best practices from the American Congress of Obstetricians and Gynecologists (ACOG) patient safety bundles.
- Institute proper triage and screening tools so early warning signs are not missed.
- Create a culture of patient safety.
- Practice simulation to be ready for unexpected, rare events.
Additionally, a successful program to reduce maternal mortality, first tried in California, could be adopted in other states. The California Maternal Quality Care Collaborative, an organization of more than 200 hospitals, helped to reduce California’s maternal mortality by 55 percent between 2006 and 2013, while the national mortality rate continued to rise. The Collaborative has accomplished this by providing hospitals with access to near real-time benchmarking data through its online Maternal Data Center. The Center links state birth certificate data with each hospital’s patient discharge data to generate perinatal performance metrics and quality improvement insights.
Maternal morbidity was reduced by 20.8 percent between 2014 and 2016 among the 126 hospitals participating in projects to reduce maternal hemorrhage and preeclampsia.
Initiatives like this should be considered in every state to improve the quality of care to pregnant women. Doing so enhances the chances of safe deliveries, healthy infants, and healthy mothers who retain their ability provide the care that these families need.