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Use of second-line therapies for management of massive primary postpartum hemorrhage
International Journal of Gynecology and Obstetrics 122 (2013) 238–243
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International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Use of second-line therapies for management of massive primary postpartum hemorrhage Lai-Ling Chan a,⁎, Tsz-Kin Lo a, Wai-Lam Lau a, Samuel Lau b, Bassanio Law c, Hin-Hung Tsang d, Wing-Cheong Leung a a
Department of Obstetrics and Gynecology, Kwong Wah Hospital, Hong Kong Department of Radiology, Kwong Wah Hospital, Hong Kong Department of Anesthesiology, Kwong Wah Hospital, Hong Kong d Intensive Care Unit, Kwong Wah Hospital, Hong Kong b c
a r t i c l e
i n f o
Article history: Received 4 February 2013 Received in revised form 23 March 2013 Accepted 17 May 2013 Keywords: Balloon tamponade Hysterectomy Primary postpartum hemorrhage Second-line therapy Uterine arterial embolization Uterine compression suture
a b s t r a c t Objective: To determine rates of use and success of second-line therapies for massive primary postpartum hemorrhage (PPH). Methods: A retrospective cohort study was conducted among 91 women who gave birth at Kwong Wah Hospital, Hong Kong, between January 1, 2006, and December 31, 2011. Inclusion criteria were gestational age of at least 24 weeks and massive PPH (defined as blood loss ≥1500 mL within 24 hours after birth). Second-line therapies assessed were uterine compression sutures, uterine artery embolization, and balloon tamponade after failure of uterine massage and uterotonic agents to stop bleeding. Results: The rate of massive PPH was 2.65 per 1000 births. Second-line therapies were used among 42 women with PPH, equivalent to a rate of 1.23 per 1000 births. Only 21.4% of the women who received second-line therapies required rescue hysterectomy. A rising trend was observed for the use of second-line therapies, whereas the incidence of rescue hysterectomy and estimated blood loss were found to concomitantly decrease. Conclusion: Increasing use of second-line therapies among women with massive PPH was associated with a decreasing trend for rescue hysterectomy. Obstetricians should, therefore, consider all available interventions to stop PPH, including early use of second-line options. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Primary postpartum hemorrhage (PPH) is an appreciable cause of maternal morbidity and mortality worldwide. According to the WHO, PPH accounts for approximately one-quarter of all maternal deaths globally and for approximately half of all postpartum deaths in lowincome countries [1]. The MOMS-B survey [2], which was conducted in 11 European countries in the 1990s, found a total incidence of severe PPH of 4.6 per 1000 births. The MOMS-B researchers defined severe PPH as measured blood loss of at least 1500 mL, blood loss requiring plasma expanders and/or blood products 2500 mL in 24 hours, or blood loss leading to maternal death. However, the incidence of PPH varies greatly around the world [3]. In Hong Kong, the incidence of severe PPH (defined as an estimated blood loss ≥2000 mL) increased from 2.49 to 3.88 per 1000 births from 2006 to 2010 [4]. Peripartum hysterectomy may be performed within 24 hours after birth in cases
⁎ Corresponding author at: Department of Obstetrics and Gynecology, N10 Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei, Kowloon, Hong Kong. Tel.: +852 35177830; fax: +852 35175291. E-mail address: [email protected] (L.-L. Chan).
requiring definitive management of intractable primary PPH. The UK Obstetric Surveillance System reported a peripartum hysterectomy rate of 0.41 per 1000 births [5], whereas the rates in Hong Kong during the period 2006–2010 ranged from 0.55 to 0.68 per 1000 births [4]. In 2012, the WHO revised its recommendations for the prevention and treatment of PPH, stating that second-line therapies, including surgery, uterine artery embolization (UAE), and intrauterine balloon tamponade, could be adopted when uterotonic agents fail [6]. However, no evidence is available to suggest that any second-line treatment is superior to the others for the management of massive PPH and no consensus exists about the optimal use and timing of these treatments. The aim of the present study was to evaluate the use of secondline therapies and their effects on maternal outcomes following massive PPH. 2. Materials and methods A retrospective cohort study was conducted among women who gave birth at Kwong Wah Hospital, Hong Kong, between January 1, 2006, and December 31, 2011. Inclusion criteria were gestational age of at least 24 weeks and massive primary PPH, which was defined as an estimated blood loss of at least 1500 mL within 24 hours after
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.03.027
L.-L. Chan et al. / International Journal of Gynecology and Obstetrics 122 (2013) 238–243
birth. The protocol of the present study was approved by the Kowloon West Cluster Research Ethics Committee, Hospital Authority, Hong Kong. Patient data were collected anonymously and coded for statistical analysis. Therefore, no consent was required in advance. Kwong Wah Hospital has a consultant-led maternity center staffed by experienced midwives, residents, and clinical fellows. Approximately 6000 deliveries are performed each year. Uncomplicated vaginal deliveries are conducted by midwives. Instrumental deliveries and cesarean deliveries are performed by residents under the direct or indirect supervision of clinical fellows or consultants. Overall, the rates of cesarean delivery and instrumental delivery at Kwong Wah Hospital every year are 21% and 3%–4%, respectively. Blood lost by the mother during vaginal delivery was collected in a bucket placed beneath the woman’s perineum. Blood volume was estimated with a measuring jar. Blood on bed sheets or pads was estimated subjectively by midwives or doctors. Blood lost in the operating theater was usually sucked into the measuring bottle and objectively measured, whereas blood on used gauzes was estimated by the theater staff according to a pictorial graph. Active management of the third stage of labor was adopted for all women. Routine intramuscular oxytocin/ergometrine or intravenous oxytocin was given to every woman after delivery of the anterior shoulder. Other uterotonic agents available at Kwong Wah Hospital were carboprost, rectal misoprostol, and sulprostone (before the suspension of its use in 2008). These drugs were considered to be firstline therapy for massive PPH; second-line therapies were used if first-line therapies failed to stop bleeding. The second-line therapies evaluated in the present study were uterine compression sutures, UAE, and balloon tamponade. Uterine compression sutures in use at Kwong Wah Hospital were the B-Lynch (first used in 2006) [7], Hwu (first used in 2010) [8], Cho square [9], and Hayman [10]. Interventional radiologists performed UAE during office hours or by special arrangement before scheduled surgeries in selected cases. The procedure was performed in the operating theater or the radiology department. Only Sengstaken– Blakemore tubes were available for balloon tamponade. The first case of massive PPH to be treated with balloon tamponade was in 2008. Neither uterine artery nor iliac artery ligation were performed during the present study period. Demographic data, details of delivery, and estimated blood loss were entered into an electronic database. Index cases were identified from this database. The chief investigator (L.L.C.) reviewed the medical records of these cases and gathered data for each patient on a standardized form. The data were coded and then analyzed using SPSS version 20.0 (IBM, Armonk, NY, USA). Data were analyzed in groups with or without second-line therapy. Data were also analyzed according to the type of second-line therapy used (uterine compression sutures, UAE, or balloon tamponade). Treatment success was defined as no requirement for rescue hysterectomy. The success rate was calculated as a percentage with a 95% confidence interval. The P values were calculated using the χ2 test for nominal data or the Mann–Whitney U test for non-parametric continuous data. A P value of 0.05 or below was considered statistically significant. 3. Results A total of 34 296 women delivered at Kwong Wah Hospital during the present study period, 91 of whom experienced massive PPH (2.65 per 1000 births). Characteristics of the women with massive PPH are shown in Table 1, while their clinical management is outlined in Fig. 1. In all, 489 twin pregnancies were recorded; 8 of these women experienced massive PPH (16.4 per 1000 twin births). Of the 91 women with massive PPH, 13 (14.3%) required hysterectomy (0.38 per 1000 births). The time to decision for hysterectomy was 18–420 minutes after birth.
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Table 1 Characteristics of the women with massive primary postpartum hemorrhage (n = 91).a Characteristic
Distribution
Age, y BMI Parity Gestational age at delivery, wk Multiple pregnancy Cases that occurred during non-office hours Length of hospital stay, d Mode of delivery Spontaneous vaginal Instrumental (vacuum or low forceps) Elective cesarean Emergency cesarean Cause of massive PPH Uterine atony Placenta previa Placenta accreta Lower genital tract bleeding Uterine wound bleeding Others (uterine rupture, coagulopathy, retained placenta) Outcomes Estimated blood loss, L Received packed-cell transfusion Volume transfused, pints of packed cells Disseminated intravascular coagulopathy Hysterectomy
33.3 ± 4.6 21.6 ± 3.2 0 (0–3) 38.3 (26.6–41.4) 8 (8.8) 30 (33.0) 6 (3–54) 21 (23.1) 4 (4.4) 38 (41.7) 28 (30.8) 38 (41.8) 14 (15.3) 7 (7.7) 9 (9.9) 15 (16.5) 8 (8.8) 2 (1.5–20) 79 (86.8) 4 (0–77) 16 (17.6) 13 (14.3)
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); PPH, primary postpartum hemorrhage. a Values are given as mean ± standard deviation, median (range), or number (percentage).
A single maternal death occurred in the present study cohort. The affected woman had eclampsia; she underwent normal vaginal delivery, which was complicated by excessive blood loss (6.2 L). Treatment was initiated with uterotonic agents, balloon tamponade, and recombinant activated clotting factor VII (rFVIIa). The episode of massive PPH was controlled but the woman died 11 days after delivery; the primary causes of death were eclampsia and intracerebral hemorrhage. Hysterectomy was performed directly after failure of uterotonic agents among 4 women. Two of these women were multiparous and underwent cesarean delivery for placenta accreta. Both women consented to a hysterectomy if morbidly adherent placenta or massive hemorrhage were encountered. The third woman had 1 previous cesarean delivery with uterine tear and underwent emergency surgery owing to early onset of labor. This woman developed uterine atony with massive PPH and multiple uterotonic agents and rFVIIa were given intraoperatively. The decision to perform a hysterectomy was taken in light of uncontrolled bleeding; total blood loss was 10.5 L. The fourth woman underwent an uneventful emergency cesarean delivery for cord prolapse at night. However, heavy vaginal bleeding and uterine atony were noted by clinical staff on the postnatal ward. Hysterectomy was subsequently performed owing to persistent hypotension. All women with massive PPH were initially treated by intravenous infusion of oxytocin. Additional uterotonic agents were administered in 92.9% of cases with second-line therapies. Second-line therapies were used to treat massive PPH among 42 women (1.23 per 1000 women). The characteristics of the women treated with different second-line therapies were not significantly different. In all, 9 (21.4%) of the women who received second-line therapy required hysterectomy owing to treatment failure. The outcomes and success rates of the second-line therapies are shown in Fig. 2. Uterine compression suture was the most frequently used second-line therapy. When used alone, the overall success rate of this approach was 71.4% (Fig. 3), regardless of the cause of massive PPH or the type of compression suture. Table 2 shows the causes of massive PPH and modes of delivery among the present study group. The causes of massive PPH were
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Massive PPH (n=91)
Treated with secondline therapies (n=42)
Required hysterectomy (n=9)
Treated with oxytocin only (n=33)
Required hysterectomy (n=1)
Treated with oxytocin and other uterotonic agents (n=16)
Required hysterectomy (n=3)
Fig. 1. Flowchart showing the clinical management of the study group. Abbreviation: PPH, primary postpartum hemorrhage.
significantly different between the women who received second-line therapy and the women who did not (P b 0.001). By contrast, no significant between-group difference was uncovered by mode of delivery (P = 0.095). The leading cause of massive PPH in both the uterine compression sutures and balloon tamponade groups was uterine atony, whereas the use of UAE or the combination of 2 second-line therapies was mostly associated with cases of placenta previa and placenta accreta. By contrast, women who did not receive second-line therapy had diverse causes of massive PPH. Table 3 shows morbidity and mortality among women with massive PPH. There was a factitious impression that women without use of second-line therapy had less morbidity. Use of 2 second-line therapies was not associated with more adverse outcomes. No hysterectomy was reported in this group of women. When the results were scrutinized by year, a rising trend of second-line therapy usage was detected (Fig. 4). By contrast, decreasing trends were observed for rescue hysterectomy and estimated blood loss, despite an upward trend for massive PPH. Of note, an accelerated decrease in the rate of hysterectomy was observed from 2010 to 2011. 4. Discussion The rate of massive PPH detected in the present study was 2.65 per 1000 births. This rate was lower than the rates of 4.6–11.4 per 1000 births recorded in European and US countries using the same definition of massive PPH as that used in the present study [11]. The rate of hysterectomy related to massive PPH in the present study was 0.38 per 1000 births, which was also lower than the rates of 0.40–2.28 per 1000 births reported in the UK and the USA [12].
Twin pregnancy increased the risk of massive PPH by 6-fold in the present study, a finding consistent with other studies [13]. In keeping with other studies, the majority of massive PPH recorded in the present study occurred during cesarean section (72.5%) [14] and during office hours (67.0%). In all, 41.7% of all cases of massive PPH occurred during elective cesarean delivery. Uterine atony accounted for most cases of massive PPH (41.8%). Second-line therapy was adopted at the rate of 1.23 per 1000 women in the present study. In the UK as a whole, the rate was 0.22 per 1000 women [15], while in Scotland it was 2.21 per 1000 women [16]. Of the women who received second-line therapy in the present study, 21.4% required rescue hysterectomy. The success rates of the various second-line therapies were comparable with those previously reported [17]. The differences in blood loss, blood transfusion, admission to intensive care unit, and disseminated intravascular coagulopathy between the women who received second-line therapy and those who did not were expected because second-line therapy was adopted only in cases with excessive bleeding. Therefore, the 2 groups of women should not be directly compared. Women who underwent cesarean delivery and were treated with second-line therapies were predominantly managed with uterine compression sutures, UAE, or a combined approach, mainly because uterine compression sutures were readily available at Kwong Wah Hospital and easily performed by laparotomy. Cho square and Hayman sutures were performed before 2008 but were superseded by the B-Lynch suture. This latter technique required just 1 suture thread and provided effective and even tension over the uterus. Furthermore, the technique was modified to avoid re-opening the closed uterine wound in some cases. The expertise of the staff at Kwong Wah Hospital in the B-Lynch suturing procedure was further enhanced by
Second-line therapy (n=42) Uterine compression sutures (n=25) Followed by UAE (n=4)
Hyst (n=0); success rate, 100.0%
Done alone (n=21) Hyst (n=6); success rate, 71.4% (95% CI, 51.2%– 88.5%)
Balloon tamponade (n=12) Followed by UAE (n=1)
Hyst (n=0), success rate, 100.0%
Done alone (n=11) Hyst (n=2); success rate, 81.8% (95% CI, 59.1%– 100.0%)
UAE (n=5)
Followed by uterine compression sutures (n=1)
Done alone (n=4)
Hyst (n=1), success rate 75.0% (95% Hyst (n=0); CI, 39.6%– success rate, 100.0%) 100.0%
Fig. 2. Outcomes and success rates of the second-line therapies. Abbreviations: CI, confidence interval; UAE, uterine artery embolization.
L.-L. Chan et al. / International Journal of Gynecology and Obstetrics 122 (2013) 238–243
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Uterine compression sutures (n=26) Done alone (n=21) with 6 hyst (success rate, 71.4%) B-Lynch (n=15) UA (n=11) with 3 hyst
Hwu in 1 case of PP, without hyst
Hwu + B Lynch in 2 cases of PP, without hyst
PP (n=3) without hyst
Sequential use with UAE (n=5) without hyst (success rate, 100.0%) Cho square (n=2) in 1 case of PA with complete removal of placenta and hyst, and 1 case of PP, without hyst
Hayman in 1 case of UA, with hyst
UAE followed and preceded by B-Lynch in 2 cases of PA, with placenta left behind Cho square followed by UAE in 1 case of PA, with placenta left behind
PA (n=1) with complete removal of placenta and hyst
Hwu + B -Lynch followed by UAE in 2 cases of PP
Fig. 3. Use of different types of uterine compression sutures and their outcomes. Abbreviations: Hyst, hysterectomy; PA, placenta accreta, PP, placenta previa; UA, uterine atony; UAE, uterine artery embolization.
participation in workshops and the availability of specific information resources in the operating theater. If necessary, UAE was performed after uterine compression suturing to secure hemostasis. The failed cases of second-line therapy that required rescue hysterectomy all occurred before 2009. After 2009, success was achieved in every single case, possibly reflecting the institutional learning curve outlined above. Women who underwent vaginal delivery and were treated with second-line therapy were mainly managed by balloon tamponade. Sengstaken–Blakemore tubes could be inserted at the bedside under ultrasonographic guidance. The procedure was quick and easy to perform, and did not require anesthesia. It could, therefore, be undertaken by relatively inexperienced personnel. Sengstaken–Blakemore tubes were rarely inserted during cesarean delivery owing to the risk of balloon puncture by the needle and the availability of alternative options, such as uterine compression sutures.
Prospective randomized data comparing the effectiveness of different types of uterine compression sutures is lacking. In the present study, B-Lynch suture was effective among patients with uterine atony but the response varied among women with placenta previa and/or placenta accreta. Although the present study included only limited examples of Hwu with/without B-Lynch sutures, anecdotal experience of using these sutures in placenta previa was favorable. The use of B-Lynch sutures was proposed to control bleeding owing to uterine atony during cesarean delivery, Hwu with/without B-Lynch sutures for bleeding from the placental bed in cases of placenta previa or placenta accreta, and UAE with/without uterine compression sutures for placenta accreta or placenta percreta [18]. By contrast, balloon tamponade with/without UAE could be used to control bleeding caused by uterine atony after vaginal delivery or cesarean delivery after the abdomen is closed; they can also be adopted when extensive bleeding occurs in the lower genital tract after vaginal delivery.
Table 2 Mode of delivery and cause of massive primary postpartum hemorrhage among the study groups (n = 91).a Variable
Cause of massive PPH (P b 0.001) Uterine atony Placenta previa Placenta accreta Lower genital tract bleeding Others Mode of delivery (P = 0.095) Spontaneous vaginal Instrumental (vacuum or low forceps) Elective cesarean Emergency cesarean
Uterine compression sutures (n = 21)
Uterine artery embolization (n = 4)
Balloon tamponade (n = 11)
2 second-line therapies (n = 6)
Without second-line therapy (n = 49)
12 7 2 0 0
(57.2) (33.3) (9.5) (0.0) (0.0)
1 (25.0) 2 (50.0) 1 (25.0) 0 (0.0) 0 (0.0)
8 (72.7) 0 (0.0) 0 (0.0) 1 (9.1)b 2 (18.2)c
1 (16.7) 2 (33.3) 3 (50.0) 0 (0.0) 0 (0.0)
13 (26.5) 4 (8.2) 3 (6.1) 8 (16.3) 21 (42.9)
0 1 11 9
(0.0) (4.8) (52.4) (42.8)
0 (0.0) 0 (0.0) 4 (100.0) 0 (0.0)
4 (36.3) 2 (18.2) 2 (18.2) 3 (27.3)
1 (16.7)d 0 (0.0) 4 (66.6) 1 (16.7)
16 (32.7) 1 (2.0) 18 (36.7) 14 (28.6)
Abbreviation: PPH, primary postpartum hemorrhage. a Values are given as number (percentage), unless otherwise indicated. b The Sengstaken–Blakemore tube was inflated in the vagina. c One woman experienced massive bleeding after manual removal of retained product of gestation; the second woman had PPH as a result of coagulopathy. d Experienced uterine atony after spontaneous vaginal delivery; clinical management was by balloon tamponade followed by UAE.
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Table 3 Morbidity and mortality among the study group (n = 91).a Variable
Uterine compression sutures (n = 21)
Uterine artery embolization (n = 4)
Balloon tamponade (n = 11)
2 second-line therapies (n = 6)
Without second-line therapy (n = 49)
Estimated blood loss, L Packs of red blood cells transfused First SDSS scoreb Length of hospital stay, d Admitted to ICU DIC rFVIIa administered Hysterectomy Maternal death
2.0 (1.5–20.0) 4 (0–77) 3 (0–8) 7 (4–31) 8 (38.1) 5 (23.8) 3 (14.3) 6 (28.6) 0 (0.0)
5.1 (1.5–15.0) 20 (2–32) 5 (1–9) 10.5 (5–54) 3 (75.0) 2 (50.0) 1 (25.0) 1 (25.0) 0 (0.0)
2.3 (1.5–8.7) 10 (3–34) 3.5 (1–10) 8 (4–12) 8 (72.7) 5 (45.5) 2 (18.2) 2 (18.2) 1 (9.1)c
3.3 10.5 3 7.5 6 1 0 0 0
1.8 (1.5–15) 3 (0–39) 3 (0–12) 6 (3–29) 12 (24.5) 2 (4.1) 0 (0.0) 4 (8.2) 0 (0.0)
(1.6–4.5) (10–24) (0–6) (7–9) (100.0) (16.7) (0.0) (0.0) (0.0)
Abbreviations: DIC, disseminated intravascular coagulopathy; ICU, intensive care unit; rFVIIa, recombinant activated clotting factor VII; SDSS, Stein Daily Scoring System. a Values are given as median (range) or number (percentage). b SDSS scores [19] range from 0 to 26; a score ≥8 was regarded as significant mood swing. Scores were calculated from questionnaires completed by women on postpartum day 2. c The primary cause of death was eclampsia with intracranial hemorrhage.
In the present study, no hysterectomies were reported among the group that received a combination of 2 second-line therapies, regardless of the type and number of uterine compression sutures used. Stepwise use of second-line therapies might, therefore, be associated with an increased success rate of uterine compression sutures. Further studies are required to test this hypothesis. As the use of second-line therapy became more widespread over time in the present study, a reciprocal trend was observed in the rate of hysterectomy. Kwong Wah Hospital revised the institutional protocol for management of massive PPH in May 2009 and introduced the use of second-line therapy in addition to internal iliac artery ligation and hysterectomy. The use of second-line therapy increased with the rising incidence of massive PPH (Fig. 4). By 2011, staff had moved along the learning curve and become familiar with the new protocol and the use of second-line therapy. This change in skill level was associated with a sharp drop in the rate of hysterectomy. A number of limitations of the present study must be considered. The women included in the analysis attended a single center. The
obstetrician’s personal preference and department’s selective training can affect the choice of using different second-line therapies and their outcomes. Given the small number of patients included in the present study, the observed differences were of limited power. An extended study period, regular audits, and the inclusion of multiple centers are likely prerequisites for further study on the efficacy and risks of second-line therapies for massive PPH. Prospective randomized studies to show the efficacy and cost effectiveness of different second-line therapies would be difficult, if not impossible, to perform. In conclusion, massive PPH is associated with appreciable maternal morbidity and mortality. Increasing use of second-line therapies was associated with a decreasing trend of hysterectomy in the present study. Obstetricians should, therefore, consider all available interventions to stop such bleeding, including early use of second-line therapies. In addition, every maternity center should be encouraged to develop protocols for managing massive PPH. Finally, appropriate training and facilities should be provided to enable widespread adoption of second-line approaches in the treatment of massive PPH.
35
30
Use of single second-line therapy [in 10000 births]
25
Number
Use of combined therapy [in 10000 births] Incidence of hysterectomy [in 10000 births]
20
Median estimated blood loss [L] 15
Incidence of massive PPH [in 10000 births] Linear (Use of single secondline therapy [in 10000 births])
10
Linear (Use of combined therapy [in 10000 births]) Linear (Incidence of hysterectomy [in 10000 births])
5
0 2006 2007 2008 2009 2010 2011
Year Fig. 4. Use of second-line therapies and outcomes by year. Abbreviation: PPH, primary postpartum hemorrhage.
L.-L. Chan et al. / International Journal of Gynecology and Obstetrics 122 (2013) 238–243
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International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Use of second-line therapies for management of massive primary postpartum hemorrhage Lai-Ling Chan a,⁎, Tsz-Kin Lo a, Wai-Lam Lau a, Samuel Lau b, Bassanio Law c, Hin-Hung Tsang d, Wing-Cheong Leung a a
Department of Obstetrics and Gynecology, Kwong Wah Hospital, Hong Kong Department of Radiology, Kwong Wah Hospital, Hong Kong Department of Anesthesiology, Kwong Wah Hospital, Hong Kong d Intensive Care Unit, Kwong Wah Hospital, Hong Kong b c
a r t i c l e
i n f o
Article history: Received 4 February 2013 Received in revised form 23 March 2013 Accepted 17 May 2013 Keywords: Balloon tamponade Hysterectomy Primary postpartum hemorrhage Second-line therapy Uterine arterial embolization Uterine compression suture
a b s t r a c t Objective: To determine rates of use and success of second-line therapies for massive primary postpartum hemorrhage (PPH). Methods: A retrospective cohort study was conducted among 91 women who gave birth at Kwong Wah Hospital, Hong Kong, between January 1, 2006, and December 31, 2011. Inclusion criteria were gestational age of at least 24 weeks and massive PPH (defined as blood loss ≥1500 mL within 24 hours after birth). Second-line therapies assessed were uterine compression sutures, uterine artery embolization, and balloon tamponade after failure of uterine massage and uterotonic agents to stop bleeding. Results: The rate of massive PPH was 2.65 per 1000 births. Second-line therapies were used among 42 women with PPH, equivalent to a rate of 1.23 per 1000 births. Only 21.4% of the women who received second-line therapies required rescue hysterectomy. A rising trend was observed for the use of second-line therapies, whereas the incidence of rescue hysterectomy and estimated blood loss were found to concomitantly decrease. Conclusion: Increasing use of second-line therapies among women with massive PPH was associated with a decreasing trend for rescue hysterectomy. Obstetricians should, therefore, consider all available interventions to stop PPH, including early use of second-line options. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Primary postpartum hemorrhage (PPH) is an appreciable cause of maternal morbidity and mortality worldwide. According to the WHO, PPH accounts for approximately one-quarter of all maternal deaths globally and for approximately half of all postpartum deaths in lowincome countries [1]. The MOMS-B survey [2], which was conducted in 11 European countries in the 1990s, found a total incidence of severe PPH of 4.6 per 1000 births. The MOMS-B researchers defined severe PPH as measured blood loss of at least 1500 mL, blood loss requiring plasma expanders and/or blood products 2500 mL in 24 hours, or blood loss leading to maternal death. However, the incidence of PPH varies greatly around the world [3]. In Hong Kong, the incidence of severe PPH (defined as an estimated blood loss ≥2000 mL) increased from 2.49 to 3.88 per 1000 births from 2006 to 2010 [4]. Peripartum hysterectomy may be performed within 24 hours after birth in cases
⁎ Corresponding author at: Department of Obstetrics and Gynecology, N10 Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei, Kowloon, Hong Kong. Tel.: +852 35177830; fax: +852 35175291. E-mail address: [email protected] (L.-L. Chan).
requiring definitive management of intractable primary PPH. The UK Obstetric Surveillance System reported a peripartum hysterectomy rate of 0.41 per 1000 births [5], whereas the rates in Hong Kong during the period 2006–2010 ranged from 0.55 to 0.68 per 1000 births [4]. In 2012, the WHO revised its recommendations for the prevention and treatment of PPH, stating that second-line therapies, including surgery, uterine artery embolization (UAE), and intrauterine balloon tamponade, could be adopted when uterotonic agents fail [6]. However, no evidence is available to suggest that any second-line treatment is superior to the others for the management of massive PPH and no consensus exists about the optimal use and timing of these treatments. The aim of the present study was to evaluate the use of secondline therapies and their effects on maternal outcomes following massive PPH. 2. Materials and methods A retrospective cohort study was conducted among women who gave birth at Kwong Wah Hospital, Hong Kong, between January 1, 2006, and December 31, 2011. Inclusion criteria were gestational age of at least 24 weeks and massive primary PPH, which was defined as an estimated blood loss of at least 1500 mL within 24 hours after
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.03.027
L.-L. Chan et al. / International Journal of Gynecology and Obstetrics 122 (2013) 238–243
birth. The protocol of the present study was approved by the Kowloon West Cluster Research Ethics Committee, Hospital Authority, Hong Kong. Patient data were collected anonymously and coded for statistical analysis. Therefore, no consent was required in advance. Kwong Wah Hospital has a consultant-led maternity center staffed by experienced midwives, residents, and clinical fellows. Approximately 6000 deliveries are performed each year. Uncomplicated vaginal deliveries are conducted by midwives. Instrumental deliveries and cesarean deliveries are performed by residents under the direct or indirect supervision of clinical fellows or consultants. Overall, the rates of cesarean delivery and instrumental delivery at Kwong Wah Hospital every year are 21% and 3%–4%, respectively. Blood lost by the mother during vaginal delivery was collected in a bucket placed beneath the woman’s perineum. Blood volume was estimated with a measuring jar. Blood on bed sheets or pads was estimated subjectively by midwives or doctors. Blood lost in the operating theater was usually sucked into the measuring bottle and objectively measured, whereas blood on used gauzes was estimated by the theater staff according to a pictorial graph. Active management of the third stage of labor was adopted for all women. Routine intramuscular oxytocin/ergometrine or intravenous oxytocin was given to every woman after delivery of the anterior shoulder. Other uterotonic agents available at Kwong Wah Hospital were carboprost, rectal misoprostol, and sulprostone (before the suspension of its use in 2008). These drugs were considered to be firstline therapy for massive PPH; second-line therapies were used if first-line therapies failed to stop bleeding. The second-line therapies evaluated in the present study were uterine compression sutures, UAE, and balloon tamponade. Uterine compression sutures in use at Kwong Wah Hospital were the B-Lynch (first used in 2006) [7], Hwu (first used in 2010) [8], Cho square [9], and Hayman [10]. Interventional radiologists performed UAE during office hours or by special arrangement before scheduled surgeries in selected cases. The procedure was performed in the operating theater or the radiology department. Only Sengstaken– Blakemore tubes were available for balloon tamponade. The first case of massive PPH to be treated with balloon tamponade was in 2008. Neither uterine artery nor iliac artery ligation were performed during the present study period. Demographic data, details of delivery, and estimated blood loss were entered into an electronic database. Index cases were identified from this database. The chief investigator (L.L.C.) reviewed the medical records of these cases and gathered data for each patient on a standardized form. The data were coded and then analyzed using SPSS version 20.0 (IBM, Armonk, NY, USA). Data were analyzed in groups with or without second-line therapy. Data were also analyzed according to the type of second-line therapy used (uterine compression sutures, UAE, or balloon tamponade). Treatment success was defined as no requirement for rescue hysterectomy. The success rate was calculated as a percentage with a 95% confidence interval. The P values were calculated using the χ2 test for nominal data or the Mann–Whitney U test for non-parametric continuous data. A P value of 0.05 or below was considered statistically significant. 3. Results A total of 34 296 women delivered at Kwong Wah Hospital during the present study period, 91 of whom experienced massive PPH (2.65 per 1000 births). Characteristics of the women with massive PPH are shown in Table 1, while their clinical management is outlined in Fig. 1. In all, 489 twin pregnancies were recorded; 8 of these women experienced massive PPH (16.4 per 1000 twin births). Of the 91 women with massive PPH, 13 (14.3%) required hysterectomy (0.38 per 1000 births). The time to decision for hysterectomy was 18–420 minutes after birth.
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Table 1 Characteristics of the women with massive primary postpartum hemorrhage (n = 91).a Characteristic
Distribution
Age, y BMI Parity Gestational age at delivery, wk Multiple pregnancy Cases that occurred during non-office hours Length of hospital stay, d Mode of delivery Spontaneous vaginal Instrumental (vacuum or low forceps) Elective cesarean Emergency cesarean Cause of massive PPH Uterine atony Placenta previa Placenta accreta Lower genital tract bleeding Uterine wound bleeding Others (uterine rupture, coagulopathy, retained placenta) Outcomes Estimated blood loss, L Received packed-cell transfusion Volume transfused, pints of packed cells Disseminated intravascular coagulopathy Hysterectomy
33.3 ± 4.6 21.6 ± 3.2 0 (0–3) 38.3 (26.6–41.4) 8 (8.8) 30 (33.0) 6 (3–54) 21 (23.1) 4 (4.4) 38 (41.7) 28 (30.8) 38 (41.8) 14 (15.3) 7 (7.7) 9 (9.9) 15 (16.5) 8 (8.8) 2 (1.5–20) 79 (86.8) 4 (0–77) 16 (17.6) 13 (14.3)
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); PPH, primary postpartum hemorrhage. a Values are given as mean ± standard deviation, median (range), or number (percentage).
A single maternal death occurred in the present study cohort. The affected woman had eclampsia; she underwent normal vaginal delivery, which was complicated by excessive blood loss (6.2 L). Treatment was initiated with uterotonic agents, balloon tamponade, and recombinant activated clotting factor VII (rFVIIa). The episode of massive PPH was controlled but the woman died 11 days after delivery; the primary causes of death were eclampsia and intracerebral hemorrhage. Hysterectomy was performed directly after failure of uterotonic agents among 4 women. Two of these women were multiparous and underwent cesarean delivery for placenta accreta. Both women consented to a hysterectomy if morbidly adherent placenta or massive hemorrhage were encountered. The third woman had 1 previous cesarean delivery with uterine tear and underwent emergency surgery owing to early onset of labor. This woman developed uterine atony with massive PPH and multiple uterotonic agents and rFVIIa were given intraoperatively. The decision to perform a hysterectomy was taken in light of uncontrolled bleeding; total blood loss was 10.5 L. The fourth woman underwent an uneventful emergency cesarean delivery for cord prolapse at night. However, heavy vaginal bleeding and uterine atony were noted by clinical staff on the postnatal ward. Hysterectomy was subsequently performed owing to persistent hypotension. All women with massive PPH were initially treated by intravenous infusion of oxytocin. Additional uterotonic agents were administered in 92.9% of cases with second-line therapies. Second-line therapies were used to treat massive PPH among 42 women (1.23 per 1000 women). The characteristics of the women treated with different second-line therapies were not significantly different. In all, 9 (21.4%) of the women who received second-line therapy required hysterectomy owing to treatment failure. The outcomes and success rates of the second-line therapies are shown in Fig. 2. Uterine compression suture was the most frequently used second-line therapy. When used alone, the overall success rate of this approach was 71.4% (Fig. 3), regardless of the cause of massive PPH or the type of compression suture. Table 2 shows the causes of massive PPH and modes of delivery among the present study group. The causes of massive PPH were
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Massive PPH (n=91)
Treated with secondline therapies (n=42)
Required hysterectomy (n=9)
Treated with oxytocin only (n=33)
Required hysterectomy (n=1)
Treated with oxytocin and other uterotonic agents (n=16)
Required hysterectomy (n=3)
Fig. 1. Flowchart showing the clinical management of the study group. Abbreviation: PPH, primary postpartum hemorrhage.
significantly different between the women who received second-line therapy and the women who did not (P b 0.001). By contrast, no significant between-group difference was uncovered by mode of delivery (P = 0.095). The leading cause of massive PPH in both the uterine compression sutures and balloon tamponade groups was uterine atony, whereas the use of UAE or the combination of 2 second-line therapies was mostly associated with cases of placenta previa and placenta accreta. By contrast, women who did not receive second-line therapy had diverse causes of massive PPH. Table 3 shows morbidity and mortality among women with massive PPH. There was a factitious impression that women without use of second-line therapy had less morbidity. Use of 2 second-line therapies was not associated with more adverse outcomes. No hysterectomy was reported in this group of women. When the results were scrutinized by year, a rising trend of second-line therapy usage was detected (Fig. 4). By contrast, decreasing trends were observed for rescue hysterectomy and estimated blood loss, despite an upward trend for massive PPH. Of note, an accelerated decrease in the rate of hysterectomy was observed from 2010 to 2011. 4. Discussion The rate of massive PPH detected in the present study was 2.65 per 1000 births. This rate was lower than the rates of 4.6–11.4 per 1000 births recorded in European and US countries using the same definition of massive PPH as that used in the present study [11]. The rate of hysterectomy related to massive PPH in the present study was 0.38 per 1000 births, which was also lower than the rates of 0.40–2.28 per 1000 births reported in the UK and the USA [12].
Twin pregnancy increased the risk of massive PPH by 6-fold in the present study, a finding consistent with other studies [13]. In keeping with other studies, the majority of massive PPH recorded in the present study occurred during cesarean section (72.5%) [14] and during office hours (67.0%). In all, 41.7% of all cases of massive PPH occurred during elective cesarean delivery. Uterine atony accounted for most cases of massive PPH (41.8%). Second-line therapy was adopted at the rate of 1.23 per 1000 women in the present study. In the UK as a whole, the rate was 0.22 per 1000 women [15], while in Scotland it was 2.21 per 1000 women [16]. Of the women who received second-line therapy in the present study, 21.4% required rescue hysterectomy. The success rates of the various second-line therapies were comparable with those previously reported [17]. The differences in blood loss, blood transfusion, admission to intensive care unit, and disseminated intravascular coagulopathy between the women who received second-line therapy and those who did not were expected because second-line therapy was adopted only in cases with excessive bleeding. Therefore, the 2 groups of women should not be directly compared. Women who underwent cesarean delivery and were treated with second-line therapies were predominantly managed with uterine compression sutures, UAE, or a combined approach, mainly because uterine compression sutures were readily available at Kwong Wah Hospital and easily performed by laparotomy. Cho square and Hayman sutures were performed before 2008 but were superseded by the B-Lynch suture. This latter technique required just 1 suture thread and provided effective and even tension over the uterus. Furthermore, the technique was modified to avoid re-opening the closed uterine wound in some cases. The expertise of the staff at Kwong Wah Hospital in the B-Lynch suturing procedure was further enhanced by
Second-line therapy (n=42) Uterine compression sutures (n=25) Followed by UAE (n=4)
Hyst (n=0); success rate, 100.0%
Done alone (n=21) Hyst (n=6); success rate, 71.4% (95% CI, 51.2%– 88.5%)
Balloon tamponade (n=12) Followed by UAE (n=1)
Hyst (n=0), success rate, 100.0%
Done alone (n=11) Hyst (n=2); success rate, 81.8% (95% CI, 59.1%– 100.0%)
UAE (n=5)
Followed by uterine compression sutures (n=1)
Done alone (n=4)
Hyst (n=1), success rate 75.0% (95% Hyst (n=0); CI, 39.6%– success rate, 100.0%) 100.0%
Fig. 2. Outcomes and success rates of the second-line therapies. Abbreviations: CI, confidence interval; UAE, uterine artery embolization.
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Uterine compression sutures (n=26) Done alone (n=21) with 6 hyst (success rate, 71.4%) B-Lynch (n=15) UA (n=11) with 3 hyst
Hwu in 1 case of PP, without hyst
Hwu + B Lynch in 2 cases of PP, without hyst
PP (n=3) without hyst
Sequential use with UAE (n=5) without hyst (success rate, 100.0%) Cho square (n=2) in 1 case of PA with complete removal of placenta and hyst, and 1 case of PP, without hyst
Hayman in 1 case of UA, with hyst
UAE followed and preceded by B-Lynch in 2 cases of PA, with placenta left behind Cho square followed by UAE in 1 case of PA, with placenta left behind
PA (n=1) with complete removal of placenta and hyst
Hwu + B -Lynch followed by UAE in 2 cases of PP
Fig. 3. Use of different types of uterine compression sutures and their outcomes. Abbreviations: Hyst, hysterectomy; PA, placenta accreta, PP, placenta previa; UA, uterine atony; UAE, uterine artery embolization.
participation in workshops and the availability of specific information resources in the operating theater. If necessary, UAE was performed after uterine compression suturing to secure hemostasis. The failed cases of second-line therapy that required rescue hysterectomy all occurred before 2009. After 2009, success was achieved in every single case, possibly reflecting the institutional learning curve outlined above. Women who underwent vaginal delivery and were treated with second-line therapy were mainly managed by balloon tamponade. Sengstaken–Blakemore tubes could be inserted at the bedside under ultrasonographic guidance. The procedure was quick and easy to perform, and did not require anesthesia. It could, therefore, be undertaken by relatively inexperienced personnel. Sengstaken–Blakemore tubes were rarely inserted during cesarean delivery owing to the risk of balloon puncture by the needle and the availability of alternative options, such as uterine compression sutures.
Prospective randomized data comparing the effectiveness of different types of uterine compression sutures is lacking. In the present study, B-Lynch suture was effective among patients with uterine atony but the response varied among women with placenta previa and/or placenta accreta. Although the present study included only limited examples of Hwu with/without B-Lynch sutures, anecdotal experience of using these sutures in placenta previa was favorable. The use of B-Lynch sutures was proposed to control bleeding owing to uterine atony during cesarean delivery, Hwu with/without B-Lynch sutures for bleeding from the placental bed in cases of placenta previa or placenta accreta, and UAE with/without uterine compression sutures for placenta accreta or placenta percreta [18]. By contrast, balloon tamponade with/without UAE could be used to control bleeding caused by uterine atony after vaginal delivery or cesarean delivery after the abdomen is closed; they can also be adopted when extensive bleeding occurs in the lower genital tract after vaginal delivery.
Table 2 Mode of delivery and cause of massive primary postpartum hemorrhage among the study groups (n = 91).a Variable
Cause of massive PPH (P b 0.001) Uterine atony Placenta previa Placenta accreta Lower genital tract bleeding Others Mode of delivery (P = 0.095) Spontaneous vaginal Instrumental (vacuum or low forceps) Elective cesarean Emergency cesarean
Uterine compression sutures (n = 21)
Uterine artery embolization (n = 4)
Balloon tamponade (n = 11)
2 second-line therapies (n = 6)
Without second-line therapy (n = 49)
12 7 2 0 0
(57.2) (33.3) (9.5) (0.0) (0.0)
1 (25.0) 2 (50.0) 1 (25.0) 0 (0.0) 0 (0.0)
8 (72.7) 0 (0.0) 0 (0.0) 1 (9.1)b 2 (18.2)c
1 (16.7) 2 (33.3) 3 (50.0) 0 (0.0) 0 (0.0)
13 (26.5) 4 (8.2) 3 (6.1) 8 (16.3) 21 (42.9)
0 1 11 9
(0.0) (4.8) (52.4) (42.8)
0 (0.0) 0 (0.0) 4 (100.0) 0 (0.0)
4 (36.3) 2 (18.2) 2 (18.2) 3 (27.3)
1 (16.7)d 0 (0.0) 4 (66.6) 1 (16.7)
16 (32.7) 1 (2.0) 18 (36.7) 14 (28.6)
Abbreviation: PPH, primary postpartum hemorrhage. a Values are given as number (percentage), unless otherwise indicated. b The Sengstaken–Blakemore tube was inflated in the vagina. c One woman experienced massive bleeding after manual removal of retained product of gestation; the second woman had PPH as a result of coagulopathy. d Experienced uterine atony after spontaneous vaginal delivery; clinical management was by balloon tamponade followed by UAE.
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Table 3 Morbidity and mortality among the study group (n = 91).a Variable
Uterine compression sutures (n = 21)
Uterine artery embolization (n = 4)
Balloon tamponade (n = 11)
2 second-line therapies (n = 6)
Without second-line therapy (n = 49)
Estimated blood loss, L Packs of red blood cells transfused First SDSS scoreb Length of hospital stay, d Admitted to ICU DIC rFVIIa administered Hysterectomy Maternal death
2.0 (1.5–20.0) 4 (0–77) 3 (0–8) 7 (4–31) 8 (38.1) 5 (23.8) 3 (14.3) 6 (28.6) 0 (0.0)
5.1 (1.5–15.0) 20 (2–32) 5 (1–9) 10.5 (5–54) 3 (75.0) 2 (50.0) 1 (25.0) 1 (25.0) 0 (0.0)
2.3 (1.5–8.7) 10 (3–34) 3.5 (1–10) 8 (4–12) 8 (72.7) 5 (45.5) 2 (18.2) 2 (18.2) 1 (9.1)c
3.3 10.5 3 7.5 6 1 0 0 0
1.8 (1.5–15) 3 (0–39) 3 (0–12) 6 (3–29) 12 (24.5) 2 (4.1) 0 (0.0) 4 (8.2) 0 (0.0)
(1.6–4.5) (10–24) (0–6) (7–9) (100.0) (16.7) (0.0) (0.0) (0.0)
Abbreviations: DIC, disseminated intravascular coagulopathy; ICU, intensive care unit; rFVIIa, recombinant activated clotting factor VII; SDSS, Stein Daily Scoring System. a Values are given as median (range) or number (percentage). b SDSS scores [19] range from 0 to 26; a score ≥8 was regarded as significant mood swing. Scores were calculated from questionnaires completed by women on postpartum day 2. c The primary cause of death was eclampsia with intracranial hemorrhage.
In the present study, no hysterectomies were reported among the group that received a combination of 2 second-line therapies, regardless of the type and number of uterine compression sutures used. Stepwise use of second-line therapies might, therefore, be associated with an increased success rate of uterine compression sutures. Further studies are required to test this hypothesis. As the use of second-line therapy became more widespread over time in the present study, a reciprocal trend was observed in the rate of hysterectomy. Kwong Wah Hospital revised the institutional protocol for management of massive PPH in May 2009 and introduced the use of second-line therapy in addition to internal iliac artery ligation and hysterectomy. The use of second-line therapy increased with the rising incidence of massive PPH (Fig. 4). By 2011, staff had moved along the learning curve and become familiar with the new protocol and the use of second-line therapy. This change in skill level was associated with a sharp drop in the rate of hysterectomy. A number of limitations of the present study must be considered. The women included in the analysis attended a single center. The
obstetrician’s personal preference and department’s selective training can affect the choice of using different second-line therapies and their outcomes. Given the small number of patients included in the present study, the observed differences were of limited power. An extended study period, regular audits, and the inclusion of multiple centers are likely prerequisites for further study on the efficacy and risks of second-line therapies for massive PPH. Prospective randomized studies to show the efficacy and cost effectiveness of different second-line therapies would be difficult, if not impossible, to perform. In conclusion, massive PPH is associated with appreciable maternal morbidity and mortality. Increasing use of second-line therapies was associated with a decreasing trend of hysterectomy in the present study. Obstetricians should, therefore, consider all available interventions to stop such bleeding, including early use of second-line therapies. In addition, every maternity center should be encouraged to develop protocols for managing massive PPH. Finally, appropriate training and facilities should be provided to enable widespread adoption of second-line approaches in the treatment of massive PPH.
35
30
Use of single second-line therapy [in 10000 births]
25
Number
Use of combined therapy [in 10000 births] Incidence of hysterectomy [in 10000 births]
20
Median estimated blood loss [L] 15
Incidence of massive PPH [in 10000 births] Linear (Use of single secondline therapy [in 10000 births])
10
Linear (Use of combined therapy [in 10000 births]) Linear (Incidence of hysterectomy [in 10000 births])
5
0 2006 2007 2008 2009 2010 2011
Year Fig. 4. Use of second-line therapies and outcomes by year. Abbreviation: PPH, primary postpartum hemorrhage.
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