We sought to determine whether the introduction of a postpartum hemorrhage (PPH) safety program was associated with changes in clinical practice and outcomes, and to examine whether these changes were sustained over time. In August 2008, a multidisciplinary PPH patient safety program was implemented at our single tertiary care hospital. We performed a cohort study of all women with PPH from August 2007 through December 2011. Changes in clinical practice and outcomes were compared before and after the intervention. Shewhart charts were used to examine sustainability of these changes over time. During the study period 52,819 women delivered, and 3105 (5.9%) experienced PPH. After the introduction of the program there was a significant increase in the use of uterotonic medications ( P < .001), intrauterine balloon tamponade ( P = .002), B-Lynch suture placement ( P = .042), uterine artery embolization ( P = .050), and cryoprecipitate use ( P = .0222). Concomitantly, the number of days between admissions to the intensive care unit for PPH increased.
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Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality in the world. Moreover, data from a nationwide sample in the United States suggest that the rate of maternal hemorrhage has risen from 1.6% in 1994 to 2.4% in 2008. Similarly, the rate of severe PPH (ie, estimated blood loss [EBL] >1500 mL), has doubled from 1999 through 2008. As a result, The Joint Commission released a 2010 Sentinel Event Alert that urged hospitals and obstetric providers to develop and use protocols in an effort to prevent maternal morbidity and mortality related to PPH.
Several investigators have reported on clinical results after institution of PPH protocols. For instance, Lappen et al reported increased use of uterotonics in the first 6 months after the introduction of a PPH program. Skupski et al reported no maternal deaths in women with PPH after initiation of their protocol. Similarly, Shields et al reported resolution of PPH at an earlier stage and decreased use of blood products after a PPH program was started. The results of these studies, however, are limited by the relatively few women who experienced PPH and by the relatively short time frame of study after introduction of the PPH protocol. It remains uncertain whether these short-term changes in management and outcomes will translate into sustained changes over time in clinical behavior or patient outcomes.
We hypothesized that the introduction of a PPH patient safety program would result in both increased utilization of interventions to prevent more severe PPH and a subsequent reduction in maternal morbidity, and that these changes would be sustained over time.
Materials and methods
This was a cohort study of the care and outcomes before and after the introduction of a PPH patient safety program at Northwestern Memorial Hospital. In August 2008, a multidisciplinary program was implemented on the labor and delivery unit at Northwestern Memorial Hospital, an urban tertiary care medical center. All perinatal nursing staff and residents, fellows, midwives, and physician providers from the departments of obstetrics and anesthesia underwent training in the early diagnosis and management of PPH. The program included: (1) mandatory educational sessions designed to improve EBL assessment with preintervention and postintervention testing, (2) introduction of a multidisciplinary checklist for PPH management, and (3) the institution of universal active management of the third stage of labor. Ongoing periodic training for incoming staff was maintained. The PPH checklist was completed by nursing staff at the time of every PPH, and included suggested steps for escalating management with larger blood loss volumes (a copy of this checklist appears in the Appendix ). The active management of the third stage of labor was instituted routinely and included administration of oxytocin (either intramuscular or intravenous) immediately following delivery of the fetus and gentle controlled cord traction to deliver the placenta. Data from the 6 months before and after this intervention were published previously, and those data are included in this longer follow-up study. For the present study, data were analyzed from 1 year before until >3 years after the start of the protocol (from August 2007 through December 2011).
Women with PPH were identified using a query of all electronic delivery records, in which mode of delivery and EBL are required fields to be completed by the obstetric provider at each delivery. Patients were included in the present analysis if they had an EBL of >500 mL for vaginal delivery, >1000 mL for cesarean delivery, or if they received a blood transfusion or uterotonic medications for obstetric hemorrhage. The records of all patients identified by the electronic search were individually reviewed to confirm the diagnosis of PPH.
Maternal demographic and obstetric data were abstracted from the medical record of all eligible subjects. Maternal demographic characteristics included age, self-reported race/ethnicity, and parity. Obstetric data included the presence of placenta previa, placenta accreta, multiple gestation, preeclampsia, magnesium sulfate use, and chorioamnionitis. Additional characteristics including gestational age at delivery, length of labor, induction of labor, use of oxytocin, and birthweight also were recorded.
Data were collected on treatments and outcomes related to PPH. Clinical interventions to control hemorrhage included the type and number of uterotonic medications (methylergonovine, prostaglandin F2-alpha, and prostaglandin E1), as well as the use of intrauterine balloon tamponade, B-Lynch suture placement, uterine artery embolization, and hysterectomy. Clinical outcomes included the type and number of blood products used (packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate), admission to the intensive care unit (ICU), and maternal death. Blood product use described in the medical record was confirmed with records from the blood bank.
Two types of analyses were performed. First, we compared variables before and after the program start using the Student t test, Wilcoxon rank sum test, or χ 2 test, as appropriate. Second, we used Shewhart charts–a type of chart frequently used in quality-control analyses–specifically to identify sustained change over time. A full description of Shewhart chart methodology is published elsewhere. For this analysis we charted variables over time in 2-month epochs and calculated appropriate control limits based on distribution of the data prior to the initiation of the patient safety program. As per standard methodology, data falling within the control limits were determined to be the result of normal variation, while data points falling outside of the control limits were considered to reflect a significant change in the system. Of note, significance is reached when only 1 data point falls outside of the control limits. P charts were used for most frequency data, while for rare outcomes, G charts were used. In selected cases, nonparametric tests of trend were performed, with the frequency of a given outcome assessed every 2 months.
Stata (version 11.1; StataCorp, College Station, TX) and MiniTab (version 17; MiniTab Inc, State College, PA) were used to analyze the data. The Northwestern University Institutional Review Board approved the study.
Results
During the study period 52,819 women delivered, of whom 3105 (5.9%) experienced a PPH. Characteristics of women who had a PPH were similar over time with the exception of the following: women in the postintervention group had a slightly greater mean maternal age and body mass index, were more likely to identify as Asian, and were more likely to have undergone induction of labor ( Table 1 ). Other factors were not different between the 2 groups.
| Patient characteristic | Pre protocol n = 592 | Post protocol n = 2513 | P value |
|---|---|---|---|
| Age, y | 31.5 ± 6.1 | 32.0 ± 5.6 | .0383 |
| Race | < .001 | ||
| Caucasian | 307 (51.9) | 1379 (54.9) | |
| Hispanic | 107 (18.1) | 444 (17.7) | |
| African American | 72 (12.2) | 282 (11.2) | |
| Asian | 19 (3.2) | 185 (7.4) | |
| Other | 87 (14.7) | 220 (8.8) | |
| Body mass index, kg/m 2 | 30.4 ± 5.9 | 31.4 ± 6.5 | < .001 |
| Prior cesarean | 71 (12.0) | 362 (14.4) | .128 |
| Multiple gestation | 75 (12.7) | 309 (12.3) | .802 |
| Twins | 72 (12.1) | 295 (11.7) | |
| Triplets | 3 (0.5) | 14 (0.6) | |
| Nulliparous | 378 (63.9) | 1543 (61.4) | .265 |
| Placenta previa | 20 (3.4) | 73 (2.9) | .544 |
| Preeclampsia | 54 (9.1) | 269 (10.7) | .258 |
| Magnesium sulfate use | 53 (9.0) | 258 (10.3) | .338 |
| Gestational age, wk | 38.6 ± 2.8 | 38.6 ± 2.7 | .879 |
| Induction of labor | 158 (26.7) | 793 (31.6) | .021 |
| Use of oxytocin | 378 (64.2) | 1659 (66.3) | .320 |
| Chorioamnionitis | 65 (11.0) | 300 (11.9) | .523 |
| Length of labor, min | 725 (453–1023) | 782 (473–1143) | .091 |
| Birthweight, g | 3349 ± 691 | 3348 ± 706 | .488 |
| Route of delivery | .067 | ||
| Spontaneous vaginal | 271 (45.8) | 1084 (43.1) | |
| Operative vaginal | 63 (10.6) | 215 (8.6) | |
| Cesarean | 258 (43.6) | 1215 (48.3) |
PPH was diagnosed more frequently after the program start (5.3% vs 6.0%, P = .002). Additionally, the proportion of all PPH that were estimated to have a volume >1500 mL increased from 21.5-26.6% after the safety program’s start ( P = .01).
Several clinical interventions to control hemorrhage were significantly different after the initiation of the program ( Table 2 ) and these changes persisted over time. Among women who had a PPH, the frequency of methergonovine, prostaglandin F2-alpha, and prostaglandin E1 use increased after the initiation of the program. Additionally, the use of ≥2 uterotonics became more frequent. After the introduction of the PPH patient safety program, the use of some procedural interventions for PPH increased as well, including use of intrauterine balloon tamponade, B-Lynch suture, and uterine artery embolization. In contrast, the use of hysterectomy for PPH did not significantly change ( P = .357). Each of the changes in management and outcomes noted above were sustained over time, as illustrated by the Shewhart charts ( Figure 1 , A and B). A similar sustained rise was seen for each individual uterotonic medication (ie, methergonovine, prostaglandin F2-alpha, and PGE1 [data not shown]).
| Patient characteristics | Pre protocol n = 592 | Post protocol n = 2513 | P value |
|---|---|---|---|
| Estimated blood loss | |||
| Clinical blood loss, mL | 1168 ± 688 | 1265 ± 905 | .014 |
| >1500 mL | 127 (21.5) | 669 (26.6) | .010 |
| Transfusions | |||
| Packed red cells | 63 (10.6) | 314 (12.5) | .214 |
| Fresh frozen plasma | 18 (3.0) | 64 (2.6) | .500 |
| Cryoprecipitate | 11 (1.9) | 94 (3.8) | .022 |
| Platelets | 7 (1.2) | 39 (1.6) | .503 |
| >2 U PRBC | 27 (4.6) | 113 (4.5) | .944 |
| >2 U fresh frozen plasma | 9 (1.5) | 36 (1.4) | .872 |
| >2 U cryoprecipitate | 1 (0.2) | 22 (0.9) | .071 |
| >2 U platelets | 1 (0.2) | 11 (0.4) | .343 |
| ≥4 U total blood products | 22 (3.7) | 106 (4.2) | .582 |
| Uterotonics used | 278 (47.0) | 1628 (64.8) | < .001 |
| PGE1 | 160 (27.0) | 1216 (48.4) | < .001 |
| Methylergonovine | 163 (27.5) | 1042 (41.5) | < .001 |
| PGF2-alpha | 128 (21.6) | 900 (35.8) | < .001 |
| >2 uterotonics | 125 (21.1) | 1064 (42.3) | < .001 |
| Intrauterine balloon tamponade | 17 (2.9) | 155 (6.2) | .002 |
| B-Lynch suture | 23 (3.9) | 151 (6.0) | .042 |
| Embolization via interventional radiology | 4 (0.7) | 45 (1.8) | .050 |
| Curettage | 29 (4.9) | 127 (5.1) | .875 |
| Gynecologic oncology present | 6 (1.0) | 30 (1.2) | .712 |
| Postpartum hysterectomy | 7 (1.2) | 43 (1.7) | .357 |
| ICU admission | 14 (2.4) | 57 (2.3) | .926 |
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