Susan C. Wallace, MPH, CRPRM
Patient Safety Analyst
Pennsylvania Patient Safety Authority

Introduction

A request from the Health Care Improvement Foundation (HCIF) for an update to a 2009 Pennsylvania Patient Safety Advisory data snapshot on maternal events led Pennsylvania Patient Safety Authority analysts to query the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for maternal events (see also the Letter to the Editor in this issue). Analysts limited the search to Serious Events over a five-year period, resulting in an examination of 537 events.

Methods

Analysts searched the database to identify Serious Events among female patients 12 to 49 years of age which were reported from January 1, 2011, through December 31, 2015.

Events were identified satisfying any of the following search criteria: (1) event types that include maternal complication of procedure/treatment/test, (2) events reported from care areas related to obstetrics, labor and delivery, and operating room venues, (3) event descriptions related to delivery with search terms including placenta, maternal, and C-section with variations (e.g., CS), or (4) event descriptions with the following terms in combination with care areas (i.e., ob*, gyn*, labor[^a]*, post-partum*): bled, bleed, blood pressure, “clot,” dehis*, deliver, edema, em*, embolism, hematom*, hemm*, hemor*, high bp, htn, hypertens*, hypotens*, intubat*, lacera*, low bp, mom, mother, neurop*, pe, pph, pulm*, seroma, skelet*, transfus*. The wildcard character (*) ensured that the search also yielded events containing other word forms (e.g., pulm* returns both pulmonary and pulmonologist).

Results

The query identified 685 event reports; 148 were excluded because they were unrelated to the scope of the query (e.g., a hysterectomy in a non-pregnant woman) or addressed a non-maternal complication event (e.g., fall), leaving 537 events for analysis.

Examination of event descriptions revealed 34 categories of possible harm or treatment (see Table). Some events could be assigned to more than one category, resulting in a total of 976 entries. The top five event categories in order of frequency were (1) unanticipated blood transfusion, (2) laceration of the birth canal, (3) unplanned transfer to the intensive care unit, (4) postpartum hemorrhage, and (5) bladder injuries. These categories were not necessarily independent (e.g., a patient may have required an unanticipated blood transfusion and an unplanned transfer to the intensive care unit). Of the 537 events analyzed, 11 (2.0%) resulted in death.

Unanticipated Blood Transfusion

Unanticipated blood transfusion was cited in 121 of the events and was the most commonly reported maternal complication. Reasons cited for bleeding included lacerations, uterine ruptures, uterine dehiscence, intra-abdominal hemorrhages, and hematomas.

Examples are as follows:*

Patient with previous C-section, attempting vaginal delivery; [fetus] had variable decelerations despite corrective action. Decision made to take patient for C-section. On entry into the abdomen in the operating room, a uterine dehiscence was identified and repaired. Patient required PRBC [packed red blood cells].

Physician performed rupture of membranes. A large amount of bright, red blood noted. STAT C-section performed. Infant delivered under general anesthesia. Mother with low hemoglobin and hematocrit, received two units of packed red blood cells.

Patient rang call bell to say that she was bleeding. Patient in pool of blood with large clots. Approximately 600 cc blood noted. Physician notified. Pitocin, Methergine and Cytotec administered. Uterine massage by physician. Bleeding stopping and fundus firm. Patient received 2 units of blood.

Laceration of the Birth Canal

Birth canal laceration was cited in 99 of the events. Third- and fourth-degree perineal lacerations, or tears, were the most commonly associated condition; seven of these reports cited newborns weighing more than 8 lb.

Examples are as follows:

Patient with excessive vaginal bleeding following delivery. Patient to operating room for vaginal exam and vaginal laceration repair.

Arrived in spontaneous labor, and pushed for three hours. The physician assisted with fetal descent by vacuum application. After delivery of the head, the anterior shoulder got stuck. The patient had a 3rd degree laceration and was taken to the operating room for repair under spinal.

Unplanned Transfer to the Intensive Care Unit

Unplanned transfer to the intensive care unit was cited in 76 events. Reasons for the unplanned transfers included cardiac and/or respiratory arrests, HELLP syndrome,^† uterine atony, uterine rupture and post-partum hemorrhage.

Examples are as follows:

Patient having C-section. Patient is obese with maternal weight [of nearly 160 kg]. [Patient] was given spinal, and after patient positioned, she complained of difficulty breathing. Oxygen saturation decreased after a minute, and the patient was bagged. The patient was transferred to an intensive care unit.

Physician in to see patient with previous C-section; attempting vaginal delivery, and patient was 8 centimeters on vaginal exam. Blood noted in Foley tubing and with exam. Patient then moved to the operating room for delivery by C-section. During surgery, it was noted that uterus and bladder had ruptured. Urologist consulted to repair bladder. Patient was transferred to the intensive care unit.

Postpartum Hemorrhage

Postpartum hemorrhage was cited in 74 events. Reasons for hemorrhage included retained placenta and uterine atony. Treatment included medications, dilation and curettage, and hysterectomy.

Examples are as follows:

Patient had a primary C-section. Returned to operating room for postpartum hemorrhage with uterine atony. Exam performed under anesthesia and balloon catheter placed. Patient tolerated procedure well.

Patient taken back to main operating room after C-section due to change in patient condition. Patient had exploratory laparoscopy with ligation of the right uterine artery to control hemorrhage.

Bladder Injury

Bladder injury was cited in 66 events. Bladder laceration was the most commonly reported bladder injury. Treatment included repair by a urologist.

Examples are as follows:

During a C-Section that was complicated by placenta previa, a placenta accreta was discovered and trauma to the bladder occurred. Urologist assisted in bladder repair.

Patient experienced an incidental bladder laceration during a cesarean section requiring urology surgeon intra-operative consultation and suture closure of bladder.

Deaths

Eleven maternal deaths were reported, including one with intra-uterine fetal death. Deaths were associated with disseminated intravascular coagulopathy, amniotic fluid emboli, gram negative bacteremia, and chronic myocarditis. Three of the patients had hysterectomies to manage postpartum bleeding. Three event reports did not specify a cause of death.

Limitations

Analysis of Serious Events is limited by the information reported through PA-PSRS, including the event descriptions. As with all reporting systems, the type and number of reports collected depend on the degree to which facility reporting is accurate and complete.

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* The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality.

^† HELLP is an abbreviation for the three main features of the syndrome: Hemolysis, Elevated Liver enzymes and Low Platelet count.

Conclusion

Analysis of PA-PSRS data revealed that the most common maternal Serious Events reported are laceration of the birth canal, postpartum hemorrhage, and bladder laceration. Life-threatening events can occur during and after delivery and, rarely, can contribute to maternal and intra-uterine fetal death. Reporting detailed circumstances related to maternal Serious Events can contribute to a better understanding of harm prevention and improved patient safety.