Bakri Balloon for Treatment of Postpartum Hemorrhage: A Real-World 2016–2020 Study in 279 Women from a Single Center

Background

Postpartum hemorrhage (PPH) is still a leading cause of maternal morbidity and mortality [1], accounting for over 2.5% of maternal deaths worldwide [2]. Various risk factors were reported for PPH, such as cesarean delivery [3] and placenta accreta [4]. Uterine atony, soft-tissues injury associated with the birth canal, and placental factors such as placenta previa are considered as the most common reasons for PPH [5]. A higher prevalence of PPH is reported in undeveloped or low-income countries than in developed or high-income countries [6]. A peripartum hysterectomy may be inevitable in case of severe PPH and showed great harm to the parturient, including loss of fertility, and high morbidity was proved to be closely associated with peripartum hysterectomies [7]. Therefore, it is still essential to explore a safer and more effective method to reduce the application of hysterectomies.

To date, various conservative procedures have been developed to control PPH. The Bakri balloon tamponade (BBT) has been recommended by the American College of Obstetricians and Gynecologists (ACOG) and WHO as a second-line conservative treatment for PPH [8]. The criteria for use of uterine tamponade were: during cesarean section and after intraoperative uterine massage and use of an uterotonic such as oxytocin and carboprost tromethamine, the presence of persistent active uterine bleeding or an amount of bleeding that reached a volume of 500 mL, and the initial treatment of PPH is usually uterotonic drugs such as oxytocin and prostaglandin. Compared with other conserving interventions, such as arterial ligation, uterine artery embolization (UAE), B-lynch compression sutures, and uterine packing, BBT requires minimal local resources and does not entail extensive training or complex equipment; it showed high effectiveness and kept the mother’s ability to bear additional children [9]. The balloon (a maximum volume of 500 mL) was inserted either transvaginally after vaginal delivery or transvaginally/transabdominally after cesarean delivery, and it was removed from the uterine cavity within 24 h. We sutured the uterine incision and carefully avoided puncturing the balloon. Ultrasonography was used to monitor its intrauterine position. A fluid collection bag connected to the BBT was used to monitor bleeding from the uterine cavity. The posterior fornix of the vagina can be packed with gauze to prevent the balloon from falling off. Although the efficacy and effectiveness of BBT has been intensively studied, conflicting evidence has also been reported [10]. Said Ali et al reviewed 28 articles and reported that BBT may be a less effective tool for management of PPH after vaginal or cesarean delivery [8]. The BBT proved an effective adjunct in management of refractory PPH, and postpartum bleeding was controlled without further surgical intervention in 95% of women, even those with uterine atony [11]. Moreover, knowledge about use of the BBT in the Chinese population with postpartum bleeding is limited and there is a lack of information on its effectiveness in real-world settings.

Therefore, the aim of this study was to present the real-world experience from a single center on the effectiveness of the BBT for the treatment of PPH in 279 women.

Material and Methods

ETHICS APPROVAL:

All procedures performed in the study were approved by the Ethics Committee of Maternal and Child Health hospital of Hubei Province (IEM XM073) and conformed to the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written or orally informed consents were obtained from all patients to participate in the study.

STUDY SUBJECTS:

A real-world database containing electronic health record data was established. A total of 279 eligible puerpera with postpartum bleeding who failed to respond to the first-line conservative management (the routine protocol for PPH) and received BBT (Cook Medical, Spencer, IN, USA) in the cohort study were recruited from January 2016 to December 2020. All eligible women were enrolled in the study if they met the following criteria. Inclusion criteria were: 1) age ≥18 years old; 2) a gestation age of ≥28 weeks; 3) received the BBT; 4) failed first-line conservative management. Exclusion criteria were: 1) those with uterine fibroids; 2) those with malignant tumors; 3) pelvic infections; 4) those with communication disorders; 5) those with abortion; 6) data obvious exceptions in the records.

CLINICAL DATA COLLECTION:

The maternal clinical characteristics of all pregnant women recruited were collected, including weight, gestational age, maternal age, parity, delivery mode (vaginal delivery and cesarean delivery), birth number, repeat cesarean section, gestational diabetes, gestational hypertension, uterine atony, placenta accrete, abnormal coagulation, placenta previa, preeclampsia. postpartum bleeding management and perinatal outcomes, such as balloon placement method, uterine contractions, suture method before using the BBT, lower genital tract trauma, intervention after using the BBT, infused volume, indwelling time, blood loss and transfusion, and perinatal complications. All data in the records were anonymized and de-identified before analysis.

CLINICAL OUTCOME MEASURES:

The primary outcome was the success rate of BBT. If the postpartum bleeding was stopped utilizing only the BBT and no further surgical interventions were involved, “BBT success” was achieved. If the BBT failed to control the bleeding, a UAE, internal iliac artery embolization (IIAE), or hysterectomy was immediately performed.

The secondary outcomes were the perinatal outcomes between the BBT Success group and BBT Failure group, the effect of delivery methods, interventional embolization on postpartum bleeding after using the BBT on perinatal outcomes, such as blood loss, and transfusion.

STATISTICAL ANALYSIS:

All analyses were performed using SPSS version 23.0 (IBM Corp, Armonk, NY). Categorical data were combined to obtain frequencies and percentages, while continuous data are presented as means±standard deviation (SD). Continuous data between 2 groups were analyzed for statistically significant differences using the t test (2-sided). Categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate. A P value of <0.05 was considered to be statistically significant.

Results

BASELINE CHARACTERISTICS AND PRIMARY OUTCOME ANALYSIS:

A total of 279 pregnant women using BBT were finally recruited in the study. Analysis of primary outcome revealed that the success rate of BBT was 88.89% (248/279, Table 1). Further analysis of baseline characteristics between the Failure group and Success group demonstrated no significant differences in parameters such as, weight, gestational age, maternal age, parity, delivery mode, and past medical history (all P>0.05).

COMPARISON OF PERINATAL OUTCOMES BETWEEN FAILURE GROUP AND SUCCESS GROUP:

The perinatal outcomes between the Failure group and Success group were compared (Table 2). The time between delivery and BBT insertion was 60.74±17.03 min in the Failure group and 89.46±9.51 min in the Success group. No significant differences were observed in time between delivery/insertion (P=0.300), different balloon placement method (P=0.670), using uterine contractions (P=0.367), or lower genital tract trauma (P=0.810). Between women with blood loss >1000 mL (n=186) and <1000 mL (n=93), BBT showed a similar effectiveness in control of bleeding (P=0.346). A total of 184 (65.95%) women received blood transfusion and no women required a hysterectomy. In the Failure group, the overwhelming majority (30/31; 96.77%) required blood transfusion, and there were 27 women who received UAE accounting for 87.10% (27/31) and 4 women received IIAE, accounting for 12.90% (4/31).

Significant differences were observed in blood loss before using the BBT, different suture method before using the BBT, intervention after using the BBT, blood loss after using the BBT, and indwelling time of BBT, blood transfusion (red blood cell, cryoprecipitate, plasma) between the Failure group and Success group (all P<0.01) The indwelling time of the balloon was significantly shorter in the Failure group than in the Success group (294.65±63.48 min vs 1071.94±23.88 min; P<0.01). Compared with the Failure group, the blood loss volumes were significantly lower in the Success group whether before using the BBT (1233.23±75.08 mL vs 1044.15±18.06 mL, P<0.01) or after using the BBT (417.10±74.25 mL vs 52.64±3.03 mL, P<0.01). Although the blood loss before and after using the BBT in the Failure group was greater than in the Success group, the Success group showed greater range of decrease in blood loss (991.56.15±13.65 mL in Success group vs 816.23±7.57 mL in Failure group). As expected, the proportion of patients receiving a blood transfusion was higher in the Failure group (30/31, 96.77%) than in the Success group (154/248, 62.10%) (P<0.01). The transfusion volumes of red blood cells, cryoprecipitate, and plasma were all higher in the Failure group than in the Success group (5.48±0.58 U vs 1.98±012 U, P<0.01; 4.85±0.53 U vs 1.37±0.12 U, P<0.01; 493.55±59.87 mL vs 148.19±12.67 mL, P<0.01), respectively.

COMPARISON OF PERINATAL COMPLICATIONS BETWEEN FAILURE GROUP AND SUCCESS GROUP:

Analysis of perinatal complications showed postoperative fever in 1 patient in each group (Table 2). The difference showed no significance (P=0.079).

Discussion

LIMITATIONS:

There are several limits in our study. The subjects are all from our single center, and the sample size was relatively small for a cohort study. BBT has been authorized for use in PPH management in China since 2012, and was introduced in our hospital in 2016. However, we believe that our study shows the real-world use status of BBT in women with postpartum bleeding in China. Further research is needed to assess correlations of the efficacy with independent predictors for BBT failure and different delivery modes.

Conclusions

The findings from this study from a single center in China supported those from previous studies, which showed that the BBT was an effective treatment to control PPH. The current research expands the knowledge about women with postpartum bleeding to better guide the clinical use of BBT in real-world settings.