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.

Scaling up interventions: findings and lessons learned from an external evaluation of Niger's National Initiative to reduce postpartum hemorrhage.

BACKGROUND: Niger has one of the highest maternal mortality ratios in Sub Saharan Africa, of which postpartum hemorrhage is the leading cause. In 2014, Health and Development International and the Ministry of Health of Niger launched an initiative to introduce and scale-up three PPH interventions in health facilities nationwide: misoprostol, uterine balloon tamponade, and the non-pneumatic anti-shock garment. METHODS: A two-phase mixed-methods evaluation was conducted to assess implementation of the initiative. Health facility assessments, provider interviews, and household surveys were conducted in May 2016 and November 2017. RESULTS: All evaluation facilities received misoprostol prevention doses. However, shortages in misoprostol treatment doses, UBT kits, and NASG stock were documented. Health provider training increased while knowledge of each PPH intervention varied. Near-universal uterotonic coverage for PPH prevention and treatment was achieved and sustained throughout the evaluation period. Use of UBT and NASG to manage PPH was rare and differed by health facility type. Among community deliveries, fewer than 22% of women received misoprostol at antenatal care for self-administered prophylaxis. Among those who did, almost all reported taking the drugs for PPH prevention in each phase. CONCLUSIONS: This study is the first external evaluation of a comprehensive PPH program taking misoprostol, UBT, and NASG to national scale in a low resource setting. Although gaps in service delivery were identified, results demonstrate the complexities of training, managing stock, and implementing system-wide interventions to reach women in varying contexts. The experience provides important lessons for other countries as they develop and expand evidence-based programs for PPH care.

Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

BACKGROUND: Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. METHODS: Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. RESULTS: Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. CONCLUSION: The ESM-UBT device appears safe for use in women with uncontrolled PPH. TRIAL REGISTRATION: Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

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.

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.

Impact of uterine balloon tamponade on the use of invasive procedures in severe postpartum hemorrhage.

INTRODUCTION: The aim of this study was to assess the impact of tamponade when uterotonic agents fail, on the need for surgery or interventional radiology. MATERIAL AND METHODS: All women who received sulprostone for postpartum hemorrhage were retrospectively compared over two periods [December 2008 to December 2010 without use of tamponade (period 1) and June 2011 to June 2013 with use of tamponade (period 2)] in the case of sulprostone failure (STROBE compliant retrospective cohort study). During period 2, interventional radiology or surgery was used only in the case of tamponade failure. RESULTS: 165 women were included (74 for period 1, 91 for period 2). The rate of interventional radiology or surgery significantly decreased from period 1 (21 of 74 women, 28.4%) to period 2 (six of 91 women, 6.6%, p = 0.0003). The rate of assumed failure of uterotonic agents was higher for period 2: 22 of 74 women (29.7%) during period 1, and 41 of 91 (45.1%, p = 0.0439) during period 2. The success rate of tamponade was 92.1% (35 of 38 women). CONCLUSIONS: Although the efficacy of tamponade should be viewed in the light of its widespread use, our findings confirm that tamponade significantly reduces the need for interventional radiology or surgery for postpartum hemorrhage treatment.

Healthcare providers experiences of using uterine balloon tamponade (UBT) devices for the treatment of post-partum haemorrhage: A meta-synthesis of qualitative studies.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of maternal mortality and severe morbidity globally. When PPH cannot be controlled using standard medical treatments, uterine balloon tamponade (UBT) may be used to arrest bleeding. While UBT is used by healthcare providers in hospital settings internationally, their views and experiences have not been systematically explored. The aim of this review is to identify, appraise and synthesize available evidence about the views and experiences of healthcare providers using UBT to treat PPH. METHODS: Using a pre-determined search strategy, we searched MEDLINE, CINAHL, PsycINFO, EMBASE, LILACS, AJOL, and reference lists of eligible studies published 1996-2019, reporting qualitative data on the views and experiences of health professionals using UBT to treat PPH. Author findings were extracted and synthesised using techniques derived from thematic synthesis and confidence in the findings was assessed using GRADE-CERQual. RESULTS: Out of 89 studies we identified 5 that met our inclusion criteria. The studies were conducted in five low- and middle-income countries (LMICs) in Africa and reported on the use of simple UBT devices for the treatment of PPH. A variety of cadres (including midwives, medical officers and clinical officers) had experience with using UBTs and found them to be effective, convenient, easy to assemble and relatively inexpensive. Providers also suggested regular, hands-on training was necessary to maintain skills and highlighted the importance of community engagement in successful implementation. CONCLUSIONS: Providers felt that administration of a simple UBT device offered a practical and cost-effective approach to the treatment of uncontrolled PPH, especially in contexts where uterotonics were ineffective or unavailable or where access to surgery was not possible. The findings are limited by the relatively small number of studies contributing to the review and further research in other contexts is required to address wider acceptability and feasibility issues.

The Discriminant Use of Intrauterine Balloon Tamponade and Compression Sutures for Management of Major Postpartum Hemorrhage: Comparison of Patient Characteristics and Clinical Outcome.

BACKGROUND: Intrauterine balloon tamponade (IUBT) and compression sutures have been widely used in recent years in the management of postpartum hemorrhage (PPH). However, there is scant literature directly comparing the clinical scenarios that led to the discriminant selection of these management modalities and the direct clinical outcomes. The purpose of this study is to compare the patient characteristics and clinical risk factors that led to the use of IUBT and compression sutures in the management of major PPH as well as the immediate outcome in a retrospective cohort. METHODS: Patients who had IUBT or compression sutures applied due to major PPH (>1000 ml) from 2014 to 2018 in a single obstetric unit were recruited. The patient characteristics and clinical outcome of the two groups were compared. RESULTS: A total of 67 patients had IUBT and 29 patients had compression sutures applied as the first uterine sparing technique. Apart from more vaginal deliveries (25.4% vs. 3.5%) in the IUBT group compared to compression sutures, there were no significant differences between the two groups in terms of patient characteristics. The IUBT group had a slightly higher blood loss at the start of the uterine sparing procedure (239 ml, p = 0.049) and received more transfusions, despite no differences in the total blood loss, hemogloblin level, incidence of coagulopathy, and intensive care unit admission between the two groups. There was no significant difference in the overall success rate between IUBT and compression sutures to control PPH without additional surgical intervention or hysterectomy (73.1% vs. 55.1%, p = 0.15) or the success rate for PPH due to uterine atony (32.8% vs. 20.7%), though IUBT apparently performed better than compression sutures in cases of placenta praevia (77.3% vs. 16.7%, p = 0.01). Blood loss > 1.5 l at the start of the procedure, presence of placenta accreta, and presence of coagulopathy were found to be significant poor prognostic factors for both procedures to control PPH. CONCLUSIONS: There were no dominating patient characteristics that favoured the selection of either IUBT or compression sutures in the management of severe PPH except for the mode of delivery. Both procedures had equally high overall success rates to control PPH, but IUBT performed better in placenta praevia cases as compared to compression sutures.

Shock progression and survival after use of a condom uterine balloon tamponade package in women with uncontrolled postpartum hemorrhage.

OBJECTIVE: To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. METHODS: In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. RESULTS: Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). CONCLUSION: The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony.

Provider experience of uterine balloon tamponade for the management of postpartum hemorrhage in Sierra Leone.

OBJECTIVE: To understand healthcare providers' experience of incorporating uterine balloon tamponade (UBT) into the national postpartum hemorrhage (PPH) clinical pathway after UBT training. METHODS: In a qualitative study, semi-structured interviews were undertaken with healthcare providers from 50 centers in Freetown, Sierra Leone, between May and June 2014. All eligible healthcare providers (undergone UBT training, actively conducted deliveries, and treated cases of PPH since UBT training) on duty at the time of center visit were interviewed. RESULTS: Sixty-one providers at 47 facilities were interviewed. Bleeding was controlled in 28 (93%) of 30 cases of UBT device placement. Participants reported that UBT devices were easy to insert with only minor challenges, and enabled providers to manage most cases of uncontrolled PPH at their own facility and to refer others in a stable condition. Reported barriers to optimal UBT use included insufficient training and practical experience, and a scarcity of preassembled UBT devices. Facilitators of UBT use included widespread acceptance of UBT, comprehensive and enthusiastic training, and ready availability of UBT devices. CONCLUSION: UBT-used either as a primary endpoint or en route to obtaining advanced care-has been well accepted and integrated into the national PPH pathway by providers in health facilities in Freetown.

Obstetric hemorrhage survey: Attitudes and practices of maternal-fetal medicine fellows.

OBJECTIVE: To evaluate experiences related to obstetric hemorrhage and suspected abnormal placentation among first year maternal-fetal medicine fellows. STUDY DESIGN: A cross-sectional anonymous survey was administered at the Society for Maternal-Fetal Medicine fellow retreat in March 2013. Fellows were asked about management strategies that reflected both their individual and institutional practices. RESULTS: There was a 56% response rate (55/98). In cases of postpartum hemorrhage due to uterine atony, there was variable use of the uterine tamponade device. The median incremental time for balloon deflation was every 5 hours (IQR = 2-12). Compared to the east coast, fellows from the west coast performed more hysterectomies (mean±SD; 2.9±2.4 vs. 1.2±1.2, p = 0.004). During a peripartum hysterectomy, 29% of fellows used a handheld cautery device such as Ligasure® or Gyrus®. Fifty-six percent responded that their institution never recommend planned delayed hysterectomies for abnormal placental implantation. CONCLUSION: There is wide variation in practice among first year maternal-fetal medicine fellows in management of peripartum hysterectomy and postpartum hemorrhage.