Intrauterine devices in the management of postpartum hemorrhage.

Obstetrical hemorrhage is a relatively frequent obstetrical complication and a common cause of maternal morbidity and mortality worldwide. The majority of maternal deaths attributable to hemorrhage are preventable, thus, developing rapid and effective means of treating postpartum hemorrhage is of critical public health importance. Intrauterine devices are one option for managing refractory hemorrhage, with rapid expansion of available devices in recent years. Intrauterine packing was historically used for this purpose, with historical cohorts documenting high rates of success. Modern packing materials, including chitosan-covered gauze, have recently been explored with success rates comparable to uterine balloon tamponade in small trials. There are a variety of balloon tamponade devices, both commercial and improvised, available for use. Efficacy of 85.9% was cited in a recent meta-analysis in resolution of hemorrhage with the use of uterine balloon devices, with greatest success in the setting of atony. However, recent randomized trials have demonstrated potential harm associated with improvised balloon tamponade use In low resource settings and the World Health Organization recommends use be restricted to settings where monitoring is available and care escalation is possible. Recently, intrauterine vacuum devices have been introduced, which offer a new mechanism for achieving hemorrhage control by mechanically restoring uterine tone via vacuum suction. The Jada device, which is is FDA-cleared and commercially available in the US, found successful bleeding control in 94% of cases in an initial single-arm trial, with recent post marketing registry study described treatment success following hemorrhage in 95.8% of vaginal and 88.2% of cesarean births. Successful use of improvised vacuum devices has been described in several studies, including suction tube uterine tamponade via Levin tubing, and use of a modified Bakri balloon. Further research is needed with head-to-head comparisons of efficacy of devices and assessment of cost within the context of both device pricing and overall healthcare resource utilization.

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.

Is it worth to insert uterine pack instead of Bakri balloon to control postpartum hemorrhage after vaginal delivery in hypertensive patients?

OBJECTIVE: To assess the safety and effectiveness of uterine packing with gauze compared to Bakri balloon to control postpartum hemorrhage (PPH) after vaginal delivery in patients with hypertensive disorders with pregnancy (HDP). METHODS: This was a prospective observational study conducted on 142 patients with HDP who suffered atonic PPH following vaginal delivery and were allocated either to insert uterine packing with gauze (n = 68) or insertion of Bakri balloon (n = 74). Success of the tamponade to arrest bleeding was the primary outcome measure. Data was collected and analyzed. RESULTS: Most of the included patients experienced spontaneous onset of labour (69%), had not receive I.V. antihypertensive drugs (83.1%) or magnesium sulphate (94.4%), or calcium channel blocker (95.7%), underwent spontaneous vaginal delivery (85.9%), received Pethidine by IMI for pain relief during labour (67.6%), did not need an episiotomy (59.2%), with spontaneous delivery of the placenta (95.77%). Bakri balloon was associated with a shorter duration to insert (p < 0.001), a higher failure rate with the need for laparotomy (p < 0.05) and more post-delivery hospital stay compared to uterine packing (p < 0.001). CONCLUSION: Although uterine packing with gauze to control PPH after vaginal delivery in patients with HDP requires a longer time to insert compared to Bakri balloon yet associated with a lesser need for laparotomy and shorter hospital stay. Larger trials are warranted to confirm or refute these findings.

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.

Bakri Balloon: an easy, useful and effective option for the treatment of postpartum haemorrhage.

We report our postpartum haemorrhage protocol focussing on the use of Bakri Balloon, describing its placement and affixing method, effectiveness rates, risk factors that might contribute to Bakri Balloon's failure and complications associated. We designed a retrospective study including 147 cases where a Bakri Balloon was necessary to control the postpartum uterine bleeding to assess the efficacy and to determine which clinical, obstetric or delivery variables could be associated with successful treatment. Failed treatment was defined when surgery or any other technique was needed after a Bakri Balloon placement in order to control uterine bleeding. For statistical analysis, we developed a descriptive analysis and a univariate logistic regression study.IMPACT STATEMENTWhat is already known on this subject? Postpartum haemorrhage is one of the most severe situations in the immediate postpartum period entailing a major cause of maternal morbimortality if an accurate and quick intervention is not carried out.What do the results of this study add? The use of Bakri Balloon was effective in 94.6% of patients. No statistically significant differences were found in the success rates according to obstetric or delivery characteristics. No major complications occurred due to the placement of a Bakri Balloon. In the failure group, blood loss was significantly higher and all required blood products transfusion.What are the implications of these findings for clinical practice and/or further research? Bakri Balloon is an easy-to-use device that provides an effective therapeutic alternative to more aggressive techniques in postpartum haemorrhages when medical treatment fails. Obstetrics or delivery characteristics should not entail a contraindication in its use. A continuous training system based on an agreed protocol is recommended in order to guarantee the best care possible.

Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

Placenta previa with posterior extrauterine adhesion: clinical features and management practice.

BACKGROUND: A diagnostic sign on magnetic resonance imaging, suggestive of posterior extrauterine adhesion (PEUA), was identified in patients with placenta previa. However, the clinical features or surgical outcomes of patients with placenta previa and PEUA are unclear. Our study aimed to investigate the clinical characteristics of placenta previa with PEUA and determine whether an altered management strategy improved surgical outcomes. METHODS: This single institution retrospective study examined patients with placenta previa who underwent cesarean delivery between 2014 and 2019. In June 2017, we recognized that PEUA was associated with increased intraoperative bleeding; thus, we altered the management of patients with placenta previa and PEUA. To assess the relationship between changes in practice and surgical outcomes, a quasi-experimental method was used to examine the difference-in-difference before (pre group) and after (post group) the changes. Surgical management was modified as follows: (i) minimization of uterine exteriorization and adhesion detachment during cesarean delivery and (ii) use of Nelaton catheters for guiding cervical passage during Bakri balloon insertion. To account for patient characteristics, propensity score matching and multivariate regression analyses were performed. RESULTS: The study cohort (n = 141) comprised of 24 patients with placenta previa and PEUA (PEUA group) and 117 non-PEUA patients (control group). The PEUA patients were further categorized into the pre (n = 12) and post groups (n = 12) based on the changes in surgical management. Total placenta previa and posterior placentas were more likely in the PEUA group than in the control group (66.7% versus 42.7% [P = 0.04] and 95.8% versus 63.2% [P < 0.01], respectively). After propensity score matching (n = 72), intraoperative blood loss was significantly higher in the PEUA group (n = 24) than in the control group (n = 48) (1515 mL versus 870 mL, P < 0.01). Multivariate regression analysis revealed that PEUA was a significant risk factor for intraoperative bleeding before changes were implemented in practice (t = 2.46, P = 0.02). Intraoperative blood loss in the post group was successfully reduced, as opposed to in the pre group (1180 mL versus 1827 mL, P = 0.04). CONCLUSIONS: PEUA was associated with total placenta previa, posterior placenta, and increased intraoperative bleeding in patients with placenta previa. Our altered management could reduce the intraoperative blood loss.

Placenta accreta spectrum disorder: a comparison between fertility-sparing techniques and hysterectomy.

This study aimed to compare fertility-sparing interventions and hysterectomy among women with placenta accreta spectrum disorder (PAS) who underwent caesarean deliveries. We retrospectively reviewed the data, and classified 148 patients as follows: group B: Bakri balloon without resection (n = 83); group R: segmental uterine resection (n = 23); and group H: hysterectomy (n = 42). The groups differed significantly with respect to operative time, transfused blood products, and post-operative intensive care unit and hospital stays. Morbidity was the highest in group H. The aforementioned parameters did not differ between Groups B and R. Groups R and H differed regarding the operative time, post-operative hospital stay, and transfused blood products. Although the treatment modality and PAS severity differed between the groups of patients with preserved fertility, the surgical outcome parameters did not differ. Hence, the effectiveness of these approaches may be similar without foregoing patient safety.IMPACT STATEMENTWhat is already known on this subject? As caesarean delivery rates have increased worldwide, the incidence of placenta accreta spectrum disorder (PAS), which has high morbidity and mortality rates, has also risen. Planned caesarean hysterectomy is recommended to reduce mortality and morbidity, but fertility is lost.What do the results of this study add? The severity of PAS can range from mild to severe. A patient-tailored approach, which was based on the intra-operative findings and used either a Bakri balloon tamponade or segmental uterine resection, reduced morbidity and preserved fertility.What are the implications of these findings for clinical practice and/or further research? Instead of adhering to the conventional approach that involves an elective caesarean hysterectomy based on antenatal imaging, more suitable approaches should be considered from the spectrum of haemostatic and fertility-preserving options available, while considering a surgeon's experience, the intra-operative findings, and patients' needs.

Experience of Bakri balloon tamponade at a single tertiary centre: a retrospective case series.

Intrauterine balloon tamponade (IUBT) is an established fertility-sparing and life-saving treatment for postpartum haemorrhage. However, high-level evidence is lacking for specific aspects of its use. Our aim was to evaluate a large case series of IUBT to inform evidence-based clinical practice. 296 cases of IUBT over a three-year period at a tertiary obstetric referral centre were identified and reviewed. Demographic, clinical, and procedural outcome measures were collected; including rates of success and failure of IUBT, duration of tamponade, and complications. IUBT was successful in 265 (90%) of women and failed in 18 (6%). All failures occurred within six hours of balloon insertion. Once deemed stable and successful at six hours, no women required return to theatre or further intervention. The mean duration of intrauterine balloon tamponade was 18.5 hours. A large variance in clinical practice exists including duration of intrauterine balloon tamponade, and method and timing of removal. A number of changes informed by the results will be introduced and prospectively audited to improve IUBT use.Impact statementWhat is already known on this subject? Intrauterine balloon tamponade (IUBT) is an important second-line treatment option in severe postpartum haemorrhage (PPH). IUBT is easy to use, is effective especially in the setting of uterine atony, and is associated with minimal complications.What the results of this study add? This study confirms the high rate of success for IUBT in controlling PPH. We found that after six hours, if deemed successful, it is rare that further intervention is required. In addition, tamponade beyond 12 hours, gradual or incremental deflation of the balloon, and antibiotic cover beyond the duration of tamponade are unlikely to yield any further safety benefit.What the implications are of these findings for clinical practice and/or further research? Our findings suggest that women should not be required to fast for balloon removal; removal of the balloon should occur by 12 hours if deemed stable and adequately resuscitated; deflation and removal of the balloon can occur at once; and antibiotics should be ceased after balloon removal. These will allow women to mobilise and recover sooner, and improve flow and throughput in our high-acuity care areas.

[Risk Analysis for Bakri Postpartum Balloon in Clinic].

Object Analyze the adverse events of bakri postpartum balloon in order to promote its safety. Methods Collect and analyze the adverse events from the National Medical Device Adverse Event Monitoring Information System and the U.S. FDA MAUDE database. Chinese and English instructions for use are comparative analysed. Results In most cases, adverse events are balloon rupture and fluid leakage, which attribute to insufficient instruction. The description of the sequence that suturing the myometrium and filling the balloon is deficient. It should be moved gently to avoid puncturing or scratching the balloon with sharp instrument. Conclusion The product instruction improvement as well as training enhancement is recommended for safety consideration. Adverse events monitoring is suggested reinforce simultaneously.

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.

Novel use of the Bakri balloon to minimize empty pelvis syndrome following laparoscopic total pelvic exenteration.

AIM: Pelvic exenteration is the only surgical option for locally advanced pelvic malignancies infiltrating the surrounding organs. The resultant pelvic void after the procedure is responsible for a number of complications, collectively termed empty pelvis syndrome (EPS). We aim to show how EPS can be minimized by presenting a case series demonstrating the surgical technique of laparoscopic total pelvic exenteration with bilateral pelvic node dissection along with a novel use of the Bakri balloon. METHOD: This is a case series of three successive patients undergoing laparoscopic total pelvic exenteration for locally advanced primary, nonmetastatic rectal adenocarcinoma over a period of 1 month in a specialized colorectal unit at a tertiary cancer centre. The Bakri balloon was deployed in all three patients and retained for variable time intervals postoperatively. Features of EPS were prospectively documented. RESULTS: In the first patient, the Bakri balloon was completely deflated and removed on postoperative day (POD) 5. The patient developed subacute intestinal obstruction which resolved with conservative management by POD 12. In the second and third patients, the Bakri balloon was deflated in a sequential manner, beginning on POD 8, until it was finally removed on POD 11. Neither of these patients had any abdominal complaints. A postoperative CT scan of both these patients showed the small bowel loops clearly above the pelvic inlet. CONCLUSIONS: The Bakri balloon is a simple, safe and cost-effective method to reduce the complications of EPS following laparoscopic total pelvic exenteration. A prospective study is ongoing to objectively quantify the benefits of this technique.

Maternal outcomes following massive obstetric haemorrhage in an inner-city maternity unit.

This retrospective study evaluates the effects of a massive postpartum haemorrhage (PPH) on maternal outcomes in an inner-city London hospital. One hundred and eighty-four cases of a massive primary PPH (>2000 mL) were identified over a seven-year period. A sub-group analysis was performed to assess whether 2000-3000 mL blood loss (134 cases) was associated with specific maternal characteristics or reduced adverse outcomes compared with >3000 mL blood loss (50 cases). Bakri balloon tamponade (BBT) was the most frequent form of surgical management in both groups (21 vs. 46%), followed by compression sutures (16.4 vs. 24%), the 'uterine sandwich' technique (6.7 vs. 14%) and the hysterectomy (0 vs. 4%). There were significant differences between these groups in placenta praevia as the cause of blood loss (8 vs. 22%, p = .01), length of stay (4.6 vs. 5.9 d, p = .02), use of BBT (p = <.01) and hysterectomy (p = .03). PPH is associated with premature maternal morbidity and mortality. The incidence is increasing in high income countries despite various guidelines, skills training and identification of risk factors. A prediction and assessment of blood loss remain the very cornerstone for a prompt, effective management. Our study shows that the morbidity is clearly related to the amount of blood loss and highlights the existing variable practices for the management of PPH. Impact statement What is already known on this subject? A postpartum haemorrhage (PPH) remains a common cause of maternal morbidity and mortality. Massive PPH (>2000 mL) rates continue to rise in developed countries. The management of PPH includes the medical treatment followed by surgical methods including the Bakri balloon tamponade (BBT), compression sutures or a hysterectomy. What do the results of this study add? This retrospective study evaluates the effects of a massive PPH (blood loss >2000 mL) on maternal outcomes. One hundred and eighty-four cases of a massive PPH were identified over a seven-year period. Sub-group analysis was performed to assess whether a 2000-3000 mL blood loss was associated with specific maternal characteristics and differences in obstetric practice compared with a >3000 mL blood loss. There were significant differences between these groups in placenta praevia, as the cause of blood loss, the length of stay, the use of BBT and the hysterectomy rates. What are the implications of these findings for clinical practice and/or further research? An early identification of the risk factors of a massive PPH is essential to improve maternal outcomes and is an important part of the antenatal, intrapartum and postpartum period. The prediction and assessment of blood loss remain key for a prompt, effective management. The amount of blood loss is related to adverse maternal outcomes and the management techniques applied. BBT has an essential role to play and should be included as part of the core training in the management of a PPH.

Intrauterine Bakri Balloon and Vaginal Tamponade Combined with Abdominal Compression for the Management of Postpartum Hemorrhage.

OBJECTIVE: This study sought to investigate the effect of Bakri balloon use and vaginal tamponade combined with abdominal compression for the management of postpartum hemorrhage (PPH). METHODS: This retrospective study reviewed cases of PPH in the International Peace Maternal and Child Health Hospital of China Welfare Institution in Shanghai, China from January 1, 2010 to December 31, 2015. A single use of the intrauterine Bakri balloon was applied in some cases, and additional vaginal tamponade combined with abdominal compression (double compression) was applied in other cases. The authors evaluated the effect of these two methods in the management of PPH. RESULTS: The Bakri balloon was used in 305 cases of intrauterine PPH, and the clinical efficacy was 93.26%. One group of study patients underwent double compression, and these patients had a better clinical efficacy rate of 96.3% (157 of 163), whereas the efficacy in cases using the Bakri balloon alone (control group) was 87.3% (124 of 142). The postoperative complication rates of these two groups were 9.4% and 8.7%, respectively. Uterine arterial embolization was performed in patients in whom Bakri balloon use failed. None of the cases resulted in a hysterectomy. CONCLUSION: Intrauterine Bakri balloon use combined with vaginal tamponade and abdominal compression is more effective in the treatment of PPH compared with Bakri balloon use alone. This method does not increase postoperative complications. Uterine atony with placenta previa or implantation may be possible reasons for noneffectiveness of Bakri balloon use.

Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.

AIM: To evaluate the success rate and protocol of the Bakri balloon for postpartum hemorrhage (PPH) in the course of a prospective observational multicenter cohort study in South China. METHODS: At 20 hospitals in South China, women with postpartum bleeding who failed to respond to the first-line conservative management and received the Bakri balloon were recruited for the study. Maternal characteristics, PPH characteristics, PPH management and outcomes in regard to the Bakri balloon use were recorded. RESULTS: A total of 472 women had a Bakri balloon tamponade and 407 (86.23%) women were enrolled (67 after vaginal delivery and 340 either during or after cesarean delivery). The success rate of the Bakri balloon in this study was 91.65% (373/407 women). During vaginal deliveries, the group with a hemorrhage >2000 mL before balloon insertion had significantly more blood loss (551.67±635.17 mL vs. 242.06±313.69 mL, P=0.039) and lower maternal hemoglobin (73±21.77 g/L vs. 92.06±19.60 g/L, P=0.029) after using Bakri balloon than the group with a hemorrhage <1000 mL. Similar data were found during cesarean deliveries. The blood loss before and after balloon insertion were significantly higher in the Bakri balloon failure group (1700±1429.88 mL before and 1209.58±1139.72 mL after using the balloon) than those in the success group [918±493.92 mL before (P=0.002) and 266.57±361.60 mL after using the balloon (P=0.001)]. CONCLUSION: Rapid diagnosis or prognosis of PPH, in combination with early usage of the Bakri postpartum balloon is more effective for the management of PPH.

Comparison of results of Bakri balloon tamponade and caesarean hysterectomy in management of placenta accreta and increta: a retrospective study.

The aim of this study was to compare the postoperative results of the patients who were treated with Bakri balloon tamponade or hysterectomy for placenta accreta and increta. Patients who were diagnosed with placenta accreta or increta preoperatively and intraoperatively and treated with Bakri balloon tamponade (Group 1) or caesarean hysterectomy (Group 2) were compared in regards to the postoperative results. Among the 36 patients diagnosed with placenta accreta or increta, 19 patients were treated with Bakri balloon tamponade while 17 cases were treated with hysterectomy. Intraoperative blood loss amount was 1794 ± 725 ml in G1, which was lower than that in G2 (2694 ± 893 ml). Blood transfusion amount was 2.7 ± 2.6 units in G1, lower than that in G2 (5.7 ± 2.4 units), too. Operation time was 64.5 ± 29 min and 140 ± 51 min in G1 and G2, respectively, showing significant differences between two groups. The success rate of Bakri balloon was determined as 84.21%. In conclusion, cases with placenta accreta/increta, with predicted placental detachment who are willing to preserve fertility, application of uterine balloon tamponade devices before the hysterectomy is encouraging with its advantages compared with the hysterectomy. Impact statement What is already known on this subject: Invasive placental anomalies are the most common indication of postpartum hysterectomy. Recently, uterine balloon tamponade was also included in the treatment modalities of postpartum haemorrhage.This study aimed to compare the postoperative results of UBT or hysterectomy for patients with placenta accreta and increta. What the results of this study add: In this study, the total amount of blood loss was higher in the caesarean hysterectomy group when compared with the Bakri balloon tamponade group. The mean transfusion requirement, mean operation time and hospitalisation period was significantly longer in the caesarean hysterectomy group. The success rate of the Bakri balloon was determined as 84.21%. Two patients who were treated with balloon application had a successful pregnancy and delivery later. Maternal mortality was reported in neither balloon nor hysterectomy groups. What the implications are of these findings for clinical practice and/or further research: In conclusion, patients diagnosed with placenta accreta/increta with ultrasound should be taken into the operation in elective conditions, if possible, on lithotomy position. In cases with predicted placental detachment that are willing to preserve fertility, application of uterine balloon tamponade devices before the hysterectomy has advantages compared with the hysterectomy.

Use of Bakri balloon tamponade (BBT) for conservative management of postpartum haemorrhage: a tertiary referral centre case series.

The aim of this study was to investigate the efficacy of the Bakri balloon in the management of PPH. This was a retrospective review of 49 patients, who had Bakri balloon inserted for PPH in KK Hospital between April 2013 and December 2015. The main outcome measure was achievement of haemostasis by Bakri balloon tamponade (BBT). Our success rate was 81.6%. Out of the nine failures (18.0%), five (55.6%) had subtotal hysterectomies and four (44.4%) had total hysterectomies. The causes of PPH in these nine women were unsuspected or foci of placenta accreta (55.6%), uterine atony (33.3%) and retained products of conception (11.1%). Our study suggests that BBT is more likely to fail when bleeding is secondary to undiagnosed focal placenta accreta (p = .011) and when the estimated blood loss is more than 1.5 litres (p < .001). Our study adds to the growing body of evidence that BBT is not only effective for management of PPH in haemodynamically stable patients and in cases secondary to uterine atony and placenta praevia, but also in a small number of undiagnosed focal placenta accreta. Impact statement There is limited evidence regarding efficacy of BBT for PPH. Our study supports the use of BBT for PPH due to uterine atony and placenta praevia and in a small number of undiagnosed placenta accreta.

Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study.

OBJECTIVE: To evaluate the effectiveness of intrauterine balloon tamponade (IUBT) for management of severe postpartum haemorrhage (PPH). To identify the factors predicting IUBT failure. DESIGN: Prospective cohort study. SETTING: Ten maternity units in a perinatal network. POPULATION: Women treated by IUBT from July 2010 to March 2013. METHODS: The global IUBT success rate was expressed as the number of women with severe PPH who were successfully treated by IUBT divided by the total number treated by IUBT. IUBT failure was defined as the need for arterial embolisation or surgery. Logistic regression analysis was used to estimate factors predicting IUBT failure. MAIN OUTCOME MEASURES: Global IUBT success rate. Factors associated with IUBT failure. RESULTS: Intrauterine balloon tamponade was attempted in 226 women: 171 after vaginal delivery (VD) (75.7%) and 55 during or after caesarean delivery (CD) (24.3%). The global success rate was 83.2% (188/226) and was significantly higher after VD (152/171, 88.9%) than CD (36/55, 65.5%, P < 0.01). The percentage of CD was significantly higher in the failure group (50.0 versus 19.1%, P < 0.01), as was mean (SD) estimated blood loss before IUBT: 1508 ± 675 ml versus 1064 ± 476, P < 0.01. Coagulopathy was significantly more frequent in the failure group (50.0% versus 17.2%, P < 0.01). CD [Odds ratio (OR) 3.5; 95% CI 1.6-7.6], estimated blood loss before IUBT (OR 3.2; 95% CI 1.5-6.8) and coagulopathy (OR 5.6; 95% CI 2.5-13.0) were predictive of IUBT failure. CONCLUSION: Intrauterine balloon tamponade is an effective method for treating severe PPH. Early balloon deployment before the development of coagulopathy increases its success rate. TWEETABLE ABSTRACT: Intrauterine balloon tamponade is effective for achieving haemostasis in intractable postpartum haemorrhages.

Comparison between two management protocols for postpartum hemorrhage during cesarean section in placenta previa: Balloon protocol versus non-balloon protocol.

AIM: This study was conducted to compare two management protocols for post-partum hemorrhage (PPH) during cesarean section (CS) in placenta previa (PP), Bakri balloon protocol versus non-balloon protocol. Secondary analysis among balloon treated cases was also performed to identify predictors of success, failure or complications, if any. METHODS: A prospective cohort study was conducted in two hospitals in Saudi Arabia, including cases that developed PPH during CS for PP. The primary outcome measure was success in preventing hysterectomy, while secondary outcome measures were amount of blood loss, need for blood transfusion, need for return to theater and admission to intensive care unit. RESULTS: One hundred and fifty-one cases were identified as low-lying placenta and PP, of which 114 developed PPH. Two patients were unstable and required immediate hysterectomy. The remaining 112 cases were managed by balloon (72 cases) or non-balloon protocols (40). The balloon alone was successful in achieving hemostasis in 87.5% of cases. When analyzed specifically, balloon success was associated with the absence of accreta (odds ratio 0.001, confidence interval 0.000-0.974) and short operation duration (odds ratio 1.143, confidence interval 1.018-1.282). CONCLUSION: Application of the Bakri balloon for the management of PPH after CS in cases of PP is an effective strategy that should be affordable worldwide.

Effect of routine rapid insertion of Bakri balloon tamponade on reducing hemorrhage from placenta previa during and after cesarean section.

PURPOSE: To evaluate the effectiveness of routine rapid insertion of a Bakri balloon during cesarean section for placenta previa based on a retrospective control study. METHODS: Women with singleton pregnancies who underwent cesarean section for placenta previa at our institution between 2003 and 2016 were enrolled. Between 2015 and 2016, women who routinely underwent balloon tamponade during cesarean section were defined as the balloon group. Between 2003 and 2014, women who underwent no hemostatic procedures except balloon tamponade were defined as the non-balloon group. The clinical outcomes of the two groups were retrospectively analyzed. RESULTS: Of the 266 women with placenta previa, 50 were in the balloon group and 216 were in the non-balloon group. The bleeding amounts were significantly smaller in the balloon group than in the non-balloon group: intraoperative bleeding (991 vs. 1250 g, p < 0.01), postoperative bleeding (62 vs. 150 g, p < 0.01), and total bleeding (1066 vs. 1451 g, p < 0.01). Furthermore, the mean surgical duration was shorter in the balloon group than the non-balloon group (30 vs. 50 min, p < 0.01). In the balloon group, five patients suffered from increasing hemorrhage due to prolapse of the balloon from the uterus after the operation, but the hemorrhage was controlled by balloon re-insertion without additional hemostatic procedures. CONCLUSIONS: This study demonstrated that the routine rapid insertion of Bakri balloon tamponade during cesarean section significantly decreased intra- and postoperative hemorrhage and shortened the surgical duration in women with placenta previa.