Uterine packing with chitosan-covered tamponade to treat postpartum hemorrhage.

Postpartum hemorrhage remains a major cause of maternal mortality and morbidity worldwide with higher rates found in resource-challenged countries. Conventional use of uterotonics such as oxytocin, prostaglandins, and medications to support coagulation, such as fibrinogen and tranexamic acid, are helpful but may not be sufficient to arrest life-threatening postpartum hemorrhage. Severe postpartum hemorrhage leads to an increased need for blood transfusions and the use of invasive techniques, such as intrauterine balloon tamponade, compression sutures, and arterial ligation, as advanced steps in the management cascade. In extreme cases where hemorrhage is resistant to these therapies, a hysterectomy may be necessary to avoid possible maternal death. Uterine packing with a chitosan-covered tamponade is an emerging tool in the armamentarium of the obstetrical team, especially when resources for advance surgical and other invasive options may be limited. Modified chitosan-impregnated gauze was originally described in the management of acute hemorrhage in the field of military medicine, combining the physiological antihemorrhaging effect of modified chitosan with a compression tamponade for the acute treatment of wound bleeding. The first described use in obstetrics was in 2012, showing that the chitosan-covered tamponade is an effective intervention to arrest ongoing therapy-resistant postpartum hemorrhage. Further studies showed a reduction in hysterectomies and blood transfusions. The method is, however, underreported and is not yet an established method used worldwide. To demonstrate the step-by-step application of the intrauterine chitosan-covered tamponade in the management of therapy-resistant postpartum hemorrhage, we have produced a teaching video to illustrate the important steps and techniques to optimize the effectiveness and safety of this novel intervention.

Intra-uterine packing: an effective and affordable tool in the management of post-partum hemorrhage - cohort study.

Introduction: postpartum hemorrhage is the main cause of maternal death worldwide. Uterine balloon packing has shown promising outcomes in PPH management. Nevertheless, its usage is limited in low- and middle-income countries due to associated costs. Uterine packing using gauzes presents a potentially efficient and cost-effective alternative. This study aims to assess the safety and efficacy of intra-uterine packing with gauzes in managing postpartum hemorrhage. Methods: this was a retrospective study over a period of two years and six months. All patients who experienced PPH due to uterine atony during vaginal delivery, with no response to medical first-line treatment, were included. IUP using gauze was employed as a second-line intervention. The primary outcome was the success of postpartum hemorrhage management. Secondary outcomes included patient vitals, the need for blood transfusion, change in hemoglobin levels (delta Hemoglobin), and maternal morbidity (post-partum infection, Sheehan syndrome, and retained gauzes). Results: the study included 63 patients. The mean age was 30.06 ± 5.6, the mean gravida was 2.65 ± 1.9 and the mean para was 2.12 ± 1.31. None of these patients experienced major complications following gauze insertion. Three patients underwent laparotomy and conservative surgical management was performed. Hysterectomy was not required for any participant, and no maternal deaths were recorded.

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial.

BACKGROUND: Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE: This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. STUDY DESIGN: This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. RESULTS: At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). CONCLUSION: The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.

The role of ultrasound in the diagnosis and management of postpartum hemorrhage.

Postpartum hemorrhage (PPH) is the leading cause of death or severe morbidity for the mother after delivery. As a consequence healthcare staff working in the delivery room should be trained to perform a prompt diagnosis and adequate management of PPH. Uneventful outcome is induced correct identification of the underlying cause of hemorrhage. Ultrasound is a promising technique for the prompt diagnosis of PPH etiology. Indeed, it is easily available, with relatively low cost, not using ionizing radiation, and can be used in different settings including the labor room, the operating theater and at the bedside of an affected women. In order to be effective Obstetricians should have an adequate knowledge of postpartum ultrasonography. In this article, we will review the sonographic findings occurring in PPH, in the differential diagnosis of the underlying cause of hemorrhage, that include retained placenta, morbidly adherent placenta, rupture of the uterus uterine, vascular anomalies of the uterine arteries and uterine inversion. We will also provide an algorithm to manage PPH according to the ultrasonographic findings.

The use of an obstetric balloon as a pelvic spacer in preventing empty pelvis syndrome after total pelvic exenteration in rectal cancers - A prospective safety and efficacy study for the Bakri balloon.

AIM: Empty pelvis syndrome (EPS) is a source of considerable morbidity following total pelvic exenteration. None of the available methods have been universally successful in mitigating this problem. The aim of this work was to evaluate the safety and efficacy of the obstetric Bakri balloon in preventing empty pelvis syndrome. METHOD: This study was a combined prospective and retrospective study of all total pelvic exenterations for rectal cancers from a single institution performed between October 2013 and May 2022. Since December 2019 the Bakri balloon was used in all patients who provided consent. EPS within 90 days was the primary end point, and included bowel obstruction, pelvic collection and entero-perineal fistula. Comparison with those patients who did not have a Bakri balloon was performed. RESULTS: Seventy-five patients with a Bakri balloon were compared with 96 patients without a balloon placed after pelvic exenteration. No patient experienced an untoward complication from balloon deployment. The incidence of EPS was 13.3% and 22.9% in the Bakri and no Bakri cohorts, respectively (p = 0.110). Every component of EPS was proportionally lower, without statistical significance. Based on point estimates, the number needed to treat to prevent EPS using the Bakri balloon was 10. CONCLUSIONS: Use of the Bakri balloon was safe without serious adverse events. The incidence of EPS after total pelvic exenteration was not statistically different with the use of the Bakri balloon despite a 9.6% reduction. A larger comparative study is needed to evaluate the efficacy of the balloon.

Traditional uterine tamponade and vacuum-induced uterine tamponade devices in obstetrical hemorrhage management.

Obstetrical hemorrhage is the leading cause of maternal morbidity and mortality worldwide, and the rates of severe hemorrhage are increasing. There is a crucial need to expand treatment options for hemorrhage to address this global crisis. Over the last decade, the evolution of hemorrhage control devices has contributed to advancements in obstetrical hemorrhage management. The number of existing hemorrhage control devices and techniques has increased markedly in recent years, and new devices are in development. The current evidence for established and investigational hemorrhage control devices has been summarized in this review. Of note, 2 main categories of devices exist: traditional uterine tamponade and vacuum-induced uterine tamponade. Although traditional intrauterine balloon tamponade devices are currently used widely in postpartum hemorrhage management, novel hemorrhage control devices and techniques have been developed. These include the minisponge tamponade device, the Jada System, a modified Bakri balloon technique, and a suction tube uterine tamponade technique. Reassuring safety data and preliminary efficacy data from pilot studies of these novel techniques support the powerful role intrauterine devices can play in obstetrical hemorrhage management. This review aimed to improve awareness of device options so that continued efforts can be made to integrate new technology into hemorrhage management protocols. Well-designed studies inclusive of new hemorrhage control devices are essential to understanding where new technology fits into preexisting obstetrical hemorrhage algorithms. In addition, access to new tamponade technology remains limited on a global scale. Programs aimed at both increasing access to devices and expanding educational initiatives are essential to make new technology a standard component for hemorrhage management.

Unilateral uterine artery embolization and Bakri tamponade balloon insertion in the treatment of acute puerperal uterine inversion: a case report.

BACKGROUND: Acute puerperal uterine inversion is rare but may cause massive postpartum blood loss due to uterine atony. Therefore, these patients must be diagnosed, and uterine replacement must be performed as soon as possible. However, in some cases, active bleeding due to uterine atony becomes uncontrollable, even though the uterine inversion itself is treated. In these cases, additional treatments, including surgical procedures, are needed. CASE PRESENTATION: A 41-year-old Japanese woman, gravida 1, para 0, was hospitalized for labor induction at 40 weeks and 3 days of gestational age. She had a vacuum-assisted delivery after 3 days of oxytocin administration, but acute uterine inversion occurred. Although replacement of the inverted uterus was successful by manual repositioning and Bakri balloon tamponade insertion, massive postpartum hemorrhage caused by uterine atony became uncontrollable. In this situation, since disseminated intravascular coagulation had developed, we used uterine artery embolization to stop the bleeding. After detecting the pseudo-aneurysmal sac and tortuous vessels of the right uterine artery, transcatheter right-sided uterine artery embolization was performed. Thirteen days after uterine artery embolization, she was discharged with no complications. CONCLUSIONS: In cases of disseminated intravascular coagulation caused by massive postpartum bleeding, uterine artery embolization may often be selected. In our case, since we performed angiography to detect the main bleeding site, the hemorrhage could be stopped with unilateral uterine artery embolization alone, without hysterectomy.

Role of balloon tamponade during cesarean section in women with placenta previa: a systematic review and meta-analysis.

INTRODUCTION: To explore the role of balloon tamponade insertion in pregnancies complicated by placenta previa. EVIDENCE ACQUISITION: Medline, Embase and ClinicalTrials.gov databases were searched electronically on October 17. Inclusion criteria were women with placenta previa undergoing, compared to those not undergoing, balloon tamponade insertion at the time of the cesarean section (CS). The outcomes observed were total, intra- and post-operative estimated blood loss (EBL), need for blood transfusion, admission to intensive care unit (ICU), hysterectomy and additional surgical or medical procedures to achieve hemostasis. Results were reported as pooled odd ratios (OR) or mean difference (MD) according to the outcome investigated. EVIDENCE SYNTHESIS: Four studies (593 women) were included. Total EBL was significantly lower in women undergoing balloon tamponade insertion during CS compared to controls (MD: -556.3, 95% CI -496 to -617.0, P=0.001). Likewise, women undergoing balloon tamponade insertion had significantly lower intra- (MD: -699.8, 95% CI -766.1 to -633.5, P=0.001) and post-operative (MD: -1162 mL (95% CI -1211.1 to -1134.4, P<0.001) compared to women who did undergo such procedure. Furthermore, women undergoing balloon tamponade insertion had a significantly lower risk of requiring additional surgical (OR: 0.16, 95% CI 0.1-0.5, I2=0%; P=0.001) or medical (OR: 0.02, 95% CI 0.003-0.1, I2=0; P=0.001) procedures to achieve hemostasis. Conversely, there was no significant difference in either the need for blood transfusion (P=0.071), admission to ICU (P=0.459) or need for hysterectomy (P=0.312) between women undergoing, compared to those not undergoing, balloon tamponade insertion during CS for placenta previa. CONCLUSIONS: Elective balloon tamponade insertion at the time of CS for placenta previa seems to be associated with a lower EBL and a reduced risk of additional medical and surgical procedures to control hemostasis. Large and adequately powered randomized controlled trials are needed to validate these results and introduce elective balloon tamponade insertion at the time of CS for placenta previa in clinical practice.

Constructing a Novel 'Uterine Sandwich' with Simultaneous Intrauterine Balloon Tamponade and Uterine Compression Sutures to Manage Postpartum Bleeding.

The uterine sandwich is a relatively new surgical technique for managing postpartum hemorrhage, which is the leading cause of maternal mortality worldwide. The purpose of this case series is to describe a novel method of constructing the uterine sandwich by simultaneously combining intrauterine balloon tamponade and uterine compression sutures. Six patients with postpartum bleeding refractory to medical management were successfully treated with this novel method and avoided hysterectomy. There were no additional complications. This novel method of constructing a uterine sandwich appears to be a simple, safe, and effective technique that could be considered in cases of persistent postpartum bleeding. More research is needed to compare the efficacy of various techniques.

Use of balloon tamponade in management of vaginal laceration and its possible complication of urinary stress incontinence: a case report.

BACKGROUND: Postpartum haemorrhage from vaginal lacerations can occasionally be refractory to suturing and vaginal packing. Bakri uterine balloon has been widely adopted to stop uterine bleeding, but its use to stop bleeding in vaginal lacerations and its possible complications have seldom been reported. CASE PRESENTATION: We report a patient who had vacuum delivery for fetal distress and subsequently had postpartum hemorrhage due to previous caesarean uterine scar rupture and multiple vaginal lacerations. The severe bleeding persisted despite total abdominal hysterectomy, pelvic embolization and vaginal gauze packing, but was finally controlled by a Bakri balloon tamponade inserted into the vagina. The patient suffered from severe stress incontinence after delivery. The possible use of balloon tamponade in vaginal lacerations and the different types of vaginal balloons that are available in the market for this purpose are reviewed. The possible causes leading to stress incontinence is reported to alert the obstetrician that such management is not free of complications. CONCLUSION: The use of Bakri balloon can help to control bleeding in severe vaginal lacerations that are unresponsive to traditional vaginal gauze packing. Further studies are needed to evaluate the risks of stress incontinence as a possible complication of vaginal balloon tamponade.

Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage. STUDY DESIGN: We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. RESULTS: Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9-87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02-16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14-0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage-related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%). CONCLUSION: Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use.

Massive hemoperitoneum due to uterine perforation by the Bakri Balloon, during the treatment of postpartum hemorrhage.

The current case describes a very rare complication of Bakri Balloon during the treatment of postpartum hemorrhage; a massive hemoperitoneum with a hemodynamic shock, due to a migration through the right broad ligament, with an anterior uterine rupture, and an irreversible wound of the right uterine artery. This event occurred even if the unfold placement was controlled with ultrasound guidance, to a patient who has never had abdominal surgery (Cesarean section included).

Massive Hemorrhage From Suspected Iatrogenic Uterine Rupture.

BACKGROUND: Intrauterine balloon tamponade is recommended for refractory postpartum hemorrhage resulting from atony, but few studies have assessed complications associated with placement. CASE: A 39-year-old woman, gravida 4 para 1, with posterior placenta previa and suspected placenta accreta had a postpartum hemorrhage after a scheduled cesarean delivery. An intrauterine balloon tamponade device was easily placed transcervically; however, the patient required additional analgesia for constant severe stabbing pain worsened on examination. Three hours after placement, the balloon was expelled from the cervix, resulting in 1,500 mL of fresh blood and clot. Emergent exploratory laparotomy identified a uterine rupture inferior and lateral to the hysterotomy site. CONCLUSION: Intrauterine balloon tamponade may contribute to iatrogenic uterine rupture and should be considered in patients with refractory hemorrhage, hemodynamic instability, or severe pain despite analgesia.

Menstrual and reproductive outcomes after use of balloon tamponade for severe postpartum hemorrhage.

BACKGROUND: The use of intrauterine balloon tamponade to manage postpartum hemorrhage is increasing. However, there is lack of studies on the menstrual and reproductive outcomes after such treatment. The purpose of this study is to explore the menstrual and reproductive outcomes for patients who had been managed by intrauterine balloon tamponade for severe postpartum hemorrhage in her index pregnancy. METHODS: All patients who had delivered in United Christian Hospital from January 2011 to June 2016 with severe postpartum hemorrhage (PPH) (blood loss> = 1 L) were identified by the labour ward delivery registry and a comprehensive obstetric database. Patients who had intrauterine balloon tamponade inserted were compared with those managed solely by uterotonic agents as controls. Patients who had hysterectomy or additional procedures performed, such as compression sutures or uterine artery embolization were excluded from both groups. A questionnaire on menses, fertility and reproductive outcomes was mailed to both groups of patients. Those that had not replied within 4 weeks would receive a telephone survey. RESULTS: A total of 39 patients in the balloon tamponade group and 161 patients in the control group were recruited, which represented 87.0% of all eligible patients within the study period. The median follow up period was 45 months. All patients in the balloon tamponade group had return of menses after delivery. The majority of the patients (87.2%) in the balloon tamponade group had normal menstrual patterns in the 12 months after the index delivery as well as in the most recent 12 months. After excluding the patients with contraception, the subsequent pregnancy rate was 42.9% (9/21) in the balloon tamponade group compared to 45.9% (28/61) in the control group (p = 0.81). Among the 9 subsequent pregnancies in the balloon tamponade group, there were two miscarriages, one scar pregnancy, one induced abortion, while the remaining five were normal pregnancies with full term deliveries without intrauterine growth restriction. The majority of patients replied that they were satisfied with using Bakri balloon for PPH management in their index pregnancy. CONCLUSIONS: Intrauterine balloon tamponade for the management of severe PPH appeared to pose little adverse effects on subsequent menstrual and reproductive function.

Altered defaecatory behaviour and faecal incontinence in a video-tracked animal model of pudendal neuropathy.

AIM: The aim was to develop a behavioural animal model of faecal continence and assess the effect of retro-uterine balloon inflation (RBI) injury. RBI in the rat causes pudendal neuropathy, a risk factor for obstetric related faecal incontinence in humans. METHOD: Video-tracking of healthy rats (n = 12) in a cage containing a latrine box was used to monitor their defaecatory behaviour index (DBI) over 2 weeks. The DBI (range 0-1) was devised by dividing the defaecation rate (pellets per hour) outside the latrine by that of the whole cage. A score of 0 indicates all pellets were deposited in the latrine. Subsequently, the effects of RBI (n = 19), sham surgery (n = 4) and colostomy (n = 2) were determined by monitoring the DBI for 2 weeks preoperatively and 3 weeks postoperatively. RESULTS: The DBI for healthy rats was 0.1 ± 0.03 with no significant change over 2 weeks (P = 0.71). In the RBI group, 13 of 19 rats (68%) showed no significant change in DBI postoperatively (0.08 ±  -0.05 vs 0.11 ±  -0.07) while in six rats the DBI increased from 0.16 ±  -0.09 to 0.46 ± 0.23. The negative control, sham surgery, did not significantly affect the DBI (0.09 ± 0.06 vs 0.08 ± 0.04, P = 0.14). The positive control, colostomy, increased the DBI from 0.26 ± 0.03 to 0.86 ± 0.08. CONCLUSIONS: This is the first study showing a quantifiable change in defaecatory behaviour following injury in an animal model. This model of pudendal neuropathy affects continence in 32% of rats and provides a basis for research on interventions for incontinence.

Clinical Usefulness of Bakri Balloon Tamponade in the Treatment of Massive Postpartum Uterine Hemorrhage.

Intrauterine globe-shaped metreurynter tamponade has been used for some time to treat massive postpartum hemorrhage (PPH). More recently, the Bakri balloon has come into use to treat PPH. It is made of silicon, possesses a drainage lumen, and has a sausage-like spindle shape. The aim of the present study was to investigate the clinical usefulness of Bakri balloon tamponade for massive PPH. Subjects in the present study comprised 5 patients with uterine atony, 3 with placenta previa, and 2 with low-lying placenta. All patients exhibited massive PPH and resistance to conventional hemostatic managements. Bakri balloon tamponade was appliedto these 10 patients. The mean amounts of uterine bleeding (average ± SD) before and after Bakri insertion were2,732 ± 1,397 mL and 380 ± 376 mL, respectively. The median (third-first quartile ranges) volume of salineinflating the balloon was 200 mL (300-150 mL). The median (third-first quartile ranges) indwelling duration of Bakri balloon was 24 hours (24-11 hrs). The overall success rate of Bakri balloon tamponade was 90% (9/10).There were no cases of slipping out or complications regarding balloon placement. Our findings suggest that Bakri balloon tamponade may be applied to the treatment of massive PPH in uterine atony and placenta previa.The Bakri balloon appears to have the following merits: (1) easy insertion into the uterine cavity and low rate of slipping out, (2) proper conformability to the hemorrhagic area due to its spindle shape, (3) ability to monitor blood loss through the drainage lumen even after insertion.