Timely use of Bakri intrauterine balloon tamponade contributes to the effectiveness in controlling severe postpartum hemorrhage
- Authors:
- Published online on: March 1, 2024 https://doi.org/10.3892/etm.2024.12465
- Article Number: 177
Abstract
Introduction
Severe postpartum hemorrhage (SPPH) occurs in ~1-2% of deliveries (1) and remains the leading global cause of severe maternal morbidity and mortality (2,3). Currently, SPPH is responsible for 25% of the 600,000 annual maternal deaths, accounting for the death toll of 150,000 women annually worldwide (4). Most maternal deaths caused by SPPH occurred within the first 24 h after birth, accounting for 33.9% in Asia (5). Longer hospital duration and higher mortality effects are usually induced by SPPH (6). SPPH may induce long-term negative mental health effects due to the increased risk for post-traumatic stress disorder (7). Although IUBT was introduced to China for the treatment of PPH in 2012, few studies have been reported among women with PPH in China, especially SPPH. Conflicting evidence about the effectiveness of Bakri IUBT was observed (8,9). As China's population ages and the three-child policy is implemented, an increase in the number of elderly pregnant women has been linked to an increased incidence of SPPH (10). The risk factors for PPH vary greatly across studies (11-13), prompting us to conduct additional research to identify the influential factors for SPPH, particularly in a high-risk maternal population.
Currently, there is no gold standard treatment for SPPH (14). Although the definition of SPPH is inconsistent in different guidelines (15-17), a total estimated blood loss (EBL) ≥1,000 ml within the first 24 h is commonly used (18). Emergency postpartum hysterectomy may be unavoidable in women with failed hemostasis and is associated with a high morbidity (19). Among various conservative procedures for controlling PPH, a Bakri IUBT has been recommended in second-line treatment (8). Compared with other conservative interventions, Bakri IUBT has demonstrated remarkable advantages in clinical application, such as minimal local resource requirement, less training and high effectiveness in fertility retention (20). However, conflicting evidence of Bakri IUBT in controlling PPH was reported, and most of the usage of IUBT was empirical (9). The second-line management for SPPH remains challenging due to a lack of evidence. Notably, the evidence for the timing of IUBT insertion on IUBT effectiveness is still lacking.
In the present study, it was aimed to explore Bakri IUBT's effectiveness in treating SPPH. The potential influential factors for Bakri's success among women with SPPH were also analyzed.
Materials and methods
Study subject
A total of 198 eligible participants with SPPH who received Bakri IUBT (Cook Medical) were included between January 2016 and December 2020 in the retrospective cohort study. All participants who received Bakri IUBT with age ≥18 years old, gestation age ≥28 weeks, failure in first-line conservative treatment, and a total of blood loss ≥1,000 ml within the first 24 h were continuously selected in the study. Women with malignant tumors, uterine fibroids, pelvic infections, abortions, or abnormal coagulation were excluded. Among these women, 105 women with placenta accrete were included. Placenta accrete was characterized by all or part of the placenta being invaded or attached abnormally to the scarred myometrium underneath (21,22). Placenta accrete was diagnosed by incomplete placental delivery, confirmed during manual placenta removal. Combining pathological examination with B-ultrasound may also be necessary. In women who gave birth vaginally, the placenta was manually removed if there were no signs of placental delivery at least 30 min after active treatment in the third stage of labor. In women with cesarean section, the placenta was also manually removed if there was no sign of placental detachment after the delivery of the fetus. In some complex cases, a multidisciplinary team was formed to ensure an accurate diagnosis of placenta accrete.
All recruited women with SPPH met the criteria of the guideline of prevention and treatment for postpartum hemorrhage (2023) in China (18). Initially, a first-line uterotonic agent or combined uterine massage was adopted. A Bakri IUBT balloon was used as a second-line option if first-line treatments failed. Bakri's success was defined as successful hemostasis with no post-IUBT intervention. Bakri failure is characterized by any post-IUBT intervention, such as uterine artery embolization (UAE), internal iliac artery embolization (IIAE), and hysterectomy. Informed consent was waived due to the nature of the retrospective study. The present study was approved by the Ethics Committee of the Maternal and Child Health Hospital of Hubei Province (approval no. 2022-IEC-XM073; Wuhan, China), and all procedures performed complied with the Declaration of Helsinki (2013).
Implementation standards of Bakri IUBT
Briefly, the presence of placental residue, birth canal lacerations and uterine vascular bleeding were confirmed before Bakri IUBT placement; ultrasound consultation was also performed if necessary. During cesarean section, a Bakri balloon was inserted from the uterine incision, with the catheter through the cervical opening. The catheter was pulled on both sides of the cervical opening by a midwife, to allow the balloon bottom contact with the cervical opening. In vaginal birth, Bakri's balloon was clamped with toothless oval cervical clamp to pass through the cervical canal and uterine opening until it reached the bottom of the uterus. The catheter was fixed on the women's thigh and the balloon was filled with sterile water. A vaginal examination was performed to ensure the correct placement of the balloon. After Bakri IUBT placement, massaging the uterus or applying pressure to the fundus was avoided. The vaginal posterior fornix was filled with gauze to prevent balloon detachment. Intravenous infusion of oxytocin for 24 h can be adopted to maintain effective uterine contractions. Routine use of antibiotics was administrated to prevent infection. The volume of blood drained by the drainage tube and the height of fundus every h were recorded. The timing of Bakri IUBT withdrawal was based on its hemostatic effect by an experienced physician. Bakri IUBT was placed inside the uterine cavity for up to 24 h, with a maximum indwelling duration of <48 h. After the balloon was completely emptied, the Bakri balloon was gently extracted from the vagina through the cervical opening. Maternal vital signs and vaginal bleeding after removing the balloon were monitored.
Data collection and measures
The maternal clinical characteristics, including baseline data and maternal outcomes of all eligible women, were analyzed. All data were deidentified before analysis. The effectiveness of Bakri IUBT, the maternal outcomes, the related factors for Bakri's success and the effect of IUBT in women with placenta accrete were all explored.
Statistical analysis
Analyses were conducted using SPSS, version 22.0 (IBM Corp). Continuous variables were presented as the mean ± standard deviation (SD) and compared using an unpaired t-test (two-sided). Categorical variables were presented as numbers and percentages and analyzed using the Chi-square test or Fisher's exact test. Logistic regression analysis was conducted to investigate the related factors for Bakri success in women with SPPH, and variables with P<0.20 in the univariable analysis were included. P<0.05 was considered to indicate a statistically significant difference.
Results
Baseline characteristics analysis in women with Bakri failure and Bakri success
Among the 198 maternal women recruited, 168 had Bakri success (84.5%; 168/198) (Table I). Analysis of baseline data revealed no significant differences in demographic and other baseline parameters such as parity, delivery mode, and past medical history between women with Bakri failure and those with Bakri success (all P>0.05). All these women were characterized by a high proportion of gestational age ≥37 weeks (90.4%; 179/198), uterine atony (42.4%; 84/198) and placenta accrete (53.0%; 105/198).
Maternal outcomes analysis in women with Bakri failure and Bakri success
The maternal outcomes of women with Bakri failure and those with Bakri success were analyzed (Table II). Among all these women, the mean duration from delivery to Bakri IUBT insertion was ≥1 h. Women with transvaginally placed Bakri IUBT accounted for 81.3% (161/198), and those with blood transfusion accounted for 80.3% (159/198). Pre-IUBT interventions, such as ‘8’ sutures, toothless oval cervical clamps and arterial ligation, were administrated in 46 (23.2%) women. None required a hysterectomy, and maternal intrapartum fever occurred in two cases. Compared with women with Bakri failure (n=30), women with Bakri success (n=168) exhibited less use of pre-IUBT intervention (χ2=14.21, P<0.01), lower genital tract trauma (χ2=3.84; P=0.04), and less total/post-IUBT EBL (t=7.17, P<0.01; t=7.56, P<0.01). A longer IUBT indwelling duration (t=6.85; P<0.01), a higher proportion of indwelling duration ≥6 h (χ2=106.99; P<0.01), and a lower use of blood transfusion [including the proportion and transfusion volume of red blood cell (RBC), cryoprecipitate and plasma; P<0.01] were also observed in women with Bakri success. Of the women with Bakri failure, 86.7% (26/30) cases received UAE and 13.3% (4/30) cases received IIAE.
Related factors analysis for Bakri success in women with SPPH
The factors associated with Bakri's success in women with SPPH were examined (Table III). The pre-IUBT variables (pre-IUBT EBL, pre-IUBT intervention, lower genital tract trauma and delivery/insertion duration) with P<0.20 from the univariate analyses in the binary logistic regression were included. The pre-IUBT intervention (OR=3.910; 95% CI: 1.684-9.079; P=0.002) was positively associated with hemostasis success, whereas lower genital tract trauma was negatively associated with Bakri success (OR=0.091; 95% CI: 0.009-0.894; P=0.040).
Analysis of baseline characteristics in women without placenta accrete and those with placenta accrete
Further, baseline characteristics in women without placenta accrete (n=93) and those with placenta accrete (n=105) were compared (Table IV). Women with placenta accrete were characterized by less uterine atony (χ2=35.27, P<0.01) and more preeclampsia (χ2=4.52; P=0.03). No significant differences in demographic and other baseline parameters were observed between women without placenta accrete and those with placenta accrete (P>0.05).
 | Table IVCharacteristics comparison between women with placenta accrete and those without placenta accrete. |
Role of Bakri IUBT in women with placenta accrete
The effects of Bakri IUBT on maternal outcomes in women with placenta accrete were analyzed (Table V). A Bakri success rate of 82.9% (87/105) was observed in women with placenta accrete, with no significant difference from that in women (87.1%, 81/93) without placenta accrete (χ2=0.69, P=0.41). An underlying decreased trend in delivery/insertion duration of IUBT was observed in women with placenta accrete compared with those without placenta accrete (χ2=1.79; P=0.08). Notably, women with placenta accrete had more transabdominally placed Bakri IUBT (χ2=9.37; P<0.01) and pre-IUBT intervention (χ2=4.96; P=0.03) than those without placenta accrete (P<0.05). No significant differences were observed in total EBL, pre-/post-IUBT EBL, infused volume of IUBT, IUBT indwelling duration, hemostasis rate, lower genital tract trauma, blood transfusion, post-IUBT intervention and puerperal fever between women with placenta accrete and those without placenta accrete (P>0.05).
| Table VMaternal outcomes analysis in women without placenta accrete and those with placenta accrete. |
Discussion
SPPH remains a life-threatening condition that causes significant maternal morbidity and mortality. The current cohort study retrospectively examined the continuous clinical data of 198 women with SPPH who underwent IUBT in a single center. The present findings demonstrated that Bakri IUBT showed a global effectiveness of 84.5% (168/198) in SPPH treatment. Even in women with placenta accrete, a Bakri success rate of 82.9% was observed. In the current study, placenta accrete may be the leading cause of SPPH, accounting for 53.0% (105/198). Logistic regression revealed that Bakri's success was positively associated with the pre-IUBT intervention (OR=3.910; 95% CI: 1.684-9.079; P=0.002) and negatively associated with lower genital tract trauma (OR=0.091; 95% CI: 0.009-0.894; P=0.040).
The effectiveness of IUBT in controlling postpartum bleeding has been the focus of research, and conflicting evidence was reported (8,9). The findings of the present study were consistent with previous studies which demonstrated that Bakri IUBT effectively managed SPPH (23,24). Conversely, IUBT was reported to be less effective for PPH treatment after vaginal or cesarean delivery in the study of Said Ali et al (8). In a randomized controlled trial by Dumont et al (25), IUBT and misoprostol vs. misoprostol alone may increase the risk of mortality and blood loss. The limited evidence concerning Chinese PPH women was searched, which supported the present findings (26,27). In a retrospective study conducted in a welfare institution in Shanghai, the Bakri IUBT resulted in an 87.3% success rate in women with PPH (124 of 142) (26). Bakri IUBT revealed a 91.7% effectiveness in the study of Wang et al (27). Liu et al (28) reviewed 106 SPPH women managed with IUBT, and the result demonstrated a 70.8% effectiveness of IUBT (75/106). In the present study, the overall success rate of Bakri IUBT for SPPH was 84.5% (168/198), even accounting for 82.9% in women with placenta accrete. The varied effectiveness may be significantly impacted by the sample recruited. For example, in the study of Liu et al (28), the women were from tertiary hospitals in first-tier cities of China with a higher proportion of cesarean delivery and a lower proportion of placenta accrete spectrum. Similarly, as reported by Wang et al (27), only 16.5% (67/407) women with vaginal delivery were enrolled, and 83.5% (340/407) received cesarean delivery. In the present study, characteristic analysis of SPPH women revealed that vaginal delivery accounted for 65.7%, placenta accrete accounted for 53.0%, and uterine atony accounted for 42.4%. The developed protocol for PPH may explain the high effectiveness of IUBT in the current study since its introduction in 2016. The use of Bakri IUBT was advocated as more active, which played a vital role in hemostasis by exerting local compression pressure on the vessels of the placental bed (29). The present findings demonstrated that Bakri IUBT effectively managed SPPH, even in women with placenta accrete.
Placenta accrete is a complication of obstetrics characterized by abnormal invasion or adherence in whole or parts to the myometrium. Placenta accrete is a pathological condition of the placenta caused by the absence or defect of decidual tissue, adhesion, invasion, or even penetration of placental villous tissue into the uterine muscle layer, including three grades, namely, ‘accreta’, ‘increta’ and ‘percreta’ (21). This prevents placental detachment, resulting in a substantially increased risk of placenta accrete spectrum, severe PPH, maternal morbidity and mortality (30,31). In past decades, the incidence of placenta accrete has increased due to the increase in in vitro fertilization techniques and cesarean section (32,33). Besides, a previous history of other uterine surgery, induced labor, curettage, uterine inflammation, or infection can lead to placenta accrete (34). There is no doubt that women with placenta accrete are at a high risk of SPPH, particularly those who have had the placenta manually removed. Placenta accrete can indicate massive bleeding or peripartum hysterectomy, therefore controlling bleeding is critical. In the present study, placenta accrete was present in >50% of cases, suggesting that placenta accrete was the leading cause of SPPH. The reason may be that Maternal and Child Health Hospital of Hubei Province received numerous women with placenta accrete from other hospitals. Further investigation into the Bakri IUBT influence demonstrated a high Bakri success rate in women with placenta accrete (82.9%, 87/105), showing no significant difference with those without placenta accrete (87.1%, 81/93). The result revealed that IUBT was effective for SPPH, even in women who had placenta accrete. Notably, a higher pre-IUBT intervention and transabdominally placed IUBT in women with placenta accrete were observed, suggesting that pre-IUBT was in favor of Bakri's success.
The present study analyzed the maternal outcomes and related factors for Bakri success in women with SPPH. In clinical practice, placental dissection usually occurs within 30 min after delivery time, and the subsequent postpartum bleeding could be remarkably rapid in some cases, including those whose placenta was manually removed. According to the guideline, IUBT was applied after the failure of the first-line conservative treatment (uterotonic agent and uterine massage), with a mean delivery/insertion duration >1 h. As demonstrated in the present study, women with Bakri failure had more significant total/post-IUBT EBL than those with Bakri success, even the pre-IUBT EBL, despite no differences. The results indicated that pre-IUBT hemostatic impairment and hemodynamic instability existed in the early phase of SPPH, and the situation of women with Bakri failure was even worse. As expected, pre-IUBT interventions (such as UAE, figure-of-8 closure, artery ligation, and toothless oval cervical clamp technique) were more common in women with Bakri failure than those with Bakri success (50.0 vs. 18.5%). Temporary uterine artery occlusion proved a theoretical fertility advantage (35). A pre-IUBT intervention may improve hemodynamic instability, ensuring enough hemodynamic stability for delivery, especially in women with Bakri failure. Further logistic regression revealed that the pre-IUBT intervention was predictive of Bakri's success, but lower genital tract trauma was not.
The timing of IUBT insertion may greatly influence Bakri's success, but the evidence is lacking. Interestingly, women with Bakri failure had a lower proportion of women with delivery/insertion duration ≥1 h and a little longer delivery/insertion duration than those with Bakri success (though no differences were observed). The result highlighted the importance of early use of IUBT insertion and the doctor's favorable sense of timing. In the study of Wang et al (36), the timely insertion of IUBT after delivery could effectively enhance the perinatal outcome of PPH and reduce the cesarean section rate. Similarly, Wang et al (27) reported that a combination of rapid diagnosis of PPH with early IUBT use was more effective in managing PPH. Indeed, the indwelling time of IUBT can be influenced by the timing of insertion. The current findings revealed that women with Bakri success had a longer indwelling time and a higher proportion of indwelling duration ≥6 h, indicating a positive correlation between long indwelling time and good maternal outcome. Thus, 4-6 h of IUBT duration was recommended to achieve hemostasis by Green-top Guideline (37). In a study by Dorkham et al (38), IUBT failure occurred within 6 h after IUBT insertion. Einerson et al (39) reported that the indwelling duration of 12 h is likely sufficient for controlling bleeding and that ≥12 h may result in more postpartum fever and longer hospitalization duration. As identified by Alouini et al (40), Bakri IUBT proved to be an efficient tool for SPPH with a mean indwelling duration of 7 h (range 5-9 h). According to the manufacturer's instructions, Bakri IUBT was recommended to be removed within 24 h primarily to prevent infection and tissue necrosis. The differences in the indwelling time of the IUBT may be due to continuous bleeding that cannot be controlled with other techniques. The heterogeneity of PPH management may also be one of the reasons. From another perspective, the shorter indwelling duration may also reflect the early prolapse of IUBT from the uterus due to uterine cavity enlargement and cervical opening relaxation. The present findings suggested that early use of IUBT may be beneficial to successful hemostasis. Timely monitoring and management of balloon deflation is critical. More research is needed to investigate the effects of IUBT insertion and indwelling duration on maternal outcomes.
Inadequate filling of the uterine cavity may be one possible reason for Bakri's failure. In the study of Olsen et al (41), the maximum capacity of IUBT failed to stop bleeding in 50% of women with Bakri failure (16% balloon out of the uterus), and the most complaints were extrusion of the balloon, continued atony and post-IUBT continued bleeding (41). However, Alouini et al (40) reported Bakri IUBT with a mean filling volume of 350 ml (range 205-450 ml) and an effectiveness of 88% in women with SPPH. In the present study, no significant difference in the infused volume of IUBT was observed between women with Bakri failure (432 ml) and those with Bakri success (418 ml). It was hypothesized that the balloon infusion volume may not associate with the hemostasis effectiveness and that balloon prolapse may be untenable for Bakri failure. However, this point needs to be verified in further studies.
Transfusion is the primary treatment for SPPH. Bakri IUBT was reported to be associated with reduced blood transfusion and increased hemoglobin and hematocrit (42). Of all the women recruited in the current study, 80.3% (159/198) received blood transfusions, including RBC transfusion (80.3%), cryoprecipitate transfusion (56.6%) and plasma transfusion (58.6%). Women with Bakri failure also had a significantly higher transfusion volume and proportion of RBC, cryoprecipitate and plasma transfusions than those with Bakri success. The blood transfusion data in the Maternal and Child Health Hospital of Hubei Province may reflect the real status of the patient in China. Notably, the developed protocol for PPH played an essential role in blood transfusion, which could improve the prognosis of mothers. The massive hemostatic volume, the physical attributes of the delivery woman, and the related risk factors should all be considered.
Most PPH-related mortality deaths are considered preventable, which highlights the critical importance of risk assessment and early intervention (43,44). As described in the present study, none required postpartum hysterectomy, and women with IUBT failure immediately received a post-IUBT intervention. The uterine artery originated from a branch of the IIA, prone to spasms. IIA is a branch of the common iliac artery located at the lumbosacral intervertebral disc in front of the sacroiliac joint. In a meta-analysis by Sathe et al (45), using embolization for PPH treatment was of great effectiveness with a success rate of 89%. Kim et al (46) revealed UAE to be a safe and effective PPH treatment method with a success rate of 99.1%. UAE was also recommended in women with secondary PPH (47) combined with the placenta accrete spectrum (48). The findings of the present study indicated that an immediate post-IUBT intervention was an effective alternative to hysterectomy. For these high-risk women, preparing a detailed hemostasis plan in advance is improved. More studies are needed to verify the present findings.
Nevertheless, there are several limitations to the present study. All women were retrospectively collected from a single center, which was challenging to avoid sample selection bias and a relatively small sample size. However, the current findings added to the existing limited evidence of pre-IUBT intervention and Bakri IUBT in women with placenta accrete. More studies are still warranted to explore the potential effects of pre-IUBT intervention, lower genital tract trauma, and Bakri IUBT insertion timing on IUBT effectiveness.
In conclusion, placenta accrete may be the leading cause of SPPH. Bakri IUBT effectively and safely managed SPPH in real-world settings in China, even in women with placenta accrete. The pre-IUBT intervention and lower genital tract trauma were associated with the effectiveness of IUBT. The pre-IUBT intervention predicts Bakri's success, even in women with placenta accrete. The timely use of IUBT during labor may mitigate the effects of risk factors identified on PPH. The current findings support the use of Bakri IUBT for SPPH administration in obstetric practice.
Acknowledgements
Not applicable.
Funding
Funding: The present study was supported by the General Program from Maternal and Child Health Hospital of Hubei Province (grant no. 2021SFYM021).
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Authors' contributions
YH and FC provided input into the concept and design of the study. YH, LC and CZ collected and assembled the data, wrote the article and critically revised the article. YH and FC confirmed the authenticity of all the raw data. All authors read and approved the final version of the manuscript.
Ethics approval and consent to participate
The present study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The study was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province (approval no. 2022-IEC-XM073; Wuhan, China). Consents were waived from individuals due to the retrospective nature of the study.
Patient consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
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