Postpartum haemorrhage management: A randomized controlled trial comparing transvaginal uterine artery clamp, vacuum-assisted uterine contraction and condom tamponade.

OBJECTIVE: While there have been numerous innovations recently for the management of postpartum haemorrhage (PPH), a limited body of research supports their application during this critical complication, which contributes significantly to maternal mortality worldwide. This randomized controlled trial (RCT) aimed to evaluate the effectiveness of three interventions - transvaginal uterine artery clamp (TVUAC), vacuum-assisted uterine contraction using a suction cannula (SC), and condom tamponade (CT) - in the management of atonic PPH. METHODS: An open-label RCT was conducted among women who delivered vaginally and developed atonic PPH at a tertiary care obstetric facility. Block randomization with sealed envelopes was used to allocate eligible participants into three interventional arms with a 1:1:1 ratio. The exclusion criteria were twin deliveries, haemodynamically unstable patients, and individuals who did not provide informed consent. The primary outcome variables assessed were blood loss post-application, total blood loss, time taken for application, and time required to achieve haemostasis within each trial arm. The secondary outcomes were the need for a second instrument or surgical intervention to control bleeding, and requirement for blood transfusion. Effectiveness outcomes were analysed as intention-to-treat, whilst safety outcomes were analysed as as-treated. RESULTS: Sixteen participants were randomized to each intervention group (n = 48). TVUAC and SC demonstrated comparable outcomes, while CT lagged in all examined parameters. Following device application, blood loss was similar in both the TVUAC (235 ± 187 ml) and SC (246.5 ± 189 ml) groups. However, following the use of CT, there was blood loss of 431 ± 427 ml, although this difference was not significant (p = 0.113). When considering total blood loss, the TVUAC group (903 ± 234 ml) showed slightly higher values than the SC group (887 ± 184 ml). However, the CT group exhibited notably higher total blood loss (1068 ± 455 ml) than the TVUAC and SC groups. In terms of application time, both TVUAC (1.8 ± 1.1 min) and SC (1.6 ± 0.9 min) significantly outperformed CT (3 ± 1.3 min) (p = 0.002). Furthermore, the time interval from the diagnosis of PPH to achieving haemostasis (defined as the time taken for active haemostasis) was significantly shorter in the TVUAC group (6 ± 4 min) and the SC group (5.7 ± 1.6 min) compared with the CT group (9.7 ± 3.8 min) (p = 0.002). CONCLUSIONS: TVUAC and SC are more effective for the management of PPH than CT. However, both TVUAC and SC have advantages and disadvantages. While these results suggest a potential preference for TVUAC and SC over CT for the management of PPH, further research is necessary to validate these findings.

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings.

The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit's effectiveness and represents the main novelty. Results proved the device's effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.

Short and long-term menstrual, reproductive, and mental health outcomes after the intrauterine use of chitosan tamponade or the Bakri balloon for severe postpartum hemorrhage: an observational study.

OBJECTIVE: This retrospective follow-up study analyzes the effect of intrauterine postpartum hemorrhage (PPH) therapy on menstrual, reproductive, and mental health outcomes. METHODS: All women who delivered at a university hospital between 2016 and 2021 with PPH and who needed intrauterine therapy were included. A questionnaire on well-being, menses, fertility, and reproductive outcomes was mailed to the patients. Those who did not reply were surveyed by telephone. RESULTS: A total of 214 women treated with chitosan-covered gauze (group A) and 46 women treated with a balloon tamponade (group B) were recruited, and their short-term courses were analyzed. For long-term follow-up, 71 women of group A (33%) and 21 women of group B (46%) could be reached. A total of 89% of group A and 95% of group B had regular menstrual bleeding in the most recent 12 months; 27% (group A) and 29% (group B) were trying to conceive again, and all of them did so successfully. There were 12 deliveries, 3 ongoing pregnancies, 3 miscarriages, and 2 terminations of pregnancies (TOP) in group A and 4 deliveries, 1 miscarriage, and 2 TOPs in group B. More than half of our study participants was sorted into grade II or III of the Impact of Events Scale, indicating they experienced clinical impacts in the form of psychological sequelae. One-quarter of patients had symptoms of post-traumatic stress disorder. CONCLUSION: Chitosan gauze as well as balloon tamponade appear to have few adverse effects on subsequent menstrual and reproductive function. Women after PPH are at increased risk of long-term adverse psychological outcomes.

Especificidades técnicas no tamponamento uterino com balões e algumas dificuldades técnicas / Technical specificities in uterine tamponade with balloons and some technical difficulties

A mortalidade materna é inaceitavelmente alta. A hemorragia pós-parto encontra- se na primeira posição no mundo, tendo como principal causa específica a atonia uterina. Eventualmente, as medidas iniciais e a terapia farmacológica não são efetivas no controle do sangramento, impondo a necessidade de tratamentos invasivos, cirúrgicos ou não. Entre esses, o tamponamento uterino com balão requer recursos locais mínimos e não exige treinamento extensivo ou equipamento muito complexo. Entretanto, algumas dificuldades podem ocorrer durante a inserção, infusão ou manutenção do balão na cavidade uterina, com especificidades relacionadas à via de parto. Após o parto vaginal, a dificuldade mais prevalente é o prolapso vaginal do balão. Na cesárea, as principais dificuldades são a inserção e o posicionamento do balão na cavidade uterina, principalmente nas cesáreas eletivas. Este artigo revisa e ilustra as principais dificuldades e especificidades relacionadas ao tamponamento uterino com balões.

Maternal mortality is unacceptably high. Postpartum hemorrhage is ranked first in the world, with the main specific cause being uterine atony. Eventually, initial measures and pharmacological therapy are not effective in controlling bleeding, imposing the need for invasive treatments, surgical or not. Among these, uterine balloon tamponade requires minimal local resources and does not require extensive training or very complex equipment. However, some difficulties may occur during insertion, infusion, or maintenance of the balloon in the uterine cavity, with specificities related to the mode of delivery. After vaginal delivery, the most prevalent difficulty is vaginal balloon prolapse. In cesarean section, the main difficulty is the insertion and positioning of the balloon in the uterine cavity, especially in elective cesarean sections. This article reviews and illustrates the main difficulties and specificities related to uterine balloon tamponade.

Balões de tamponamento intrauterino na hemorragia pós-parto ­ Atualizações / Uterine balloon tamponade in postpartum hemorrhage ­ Updates

A hemorragia pós-parto continua sendo uma condição relacionada a elevada morbimortalidade materna, sendo essenciais o diagnóstico precoce e o início do tratamento farmacológico. Em caso de falha, os balões de tamponamento uterino são uma alternativa eficiente, com aplicabilidade crescente na prática clínica. Esses dispositivos são seguros, apresentam baixa incidência de eventos adversos e reduzem as taxas de procedimentos cirúrgicos. Existe uma ampla variedade de modelos, tanto industriais quanto artesanais, com acúmulo de relatos na literatura demonstrando sua eficácia. Este artigo descreve os principais balões intrauterinos, com ênfase nos modelos mais novos, aplicabilidade, taxas de sucesso e eventos adversos.(AU)

Postpartum hemorrhage continues to be a condition related to high maternal morbimortality, early diagnosis and initiation of pharmacological treatment are essential. In case of failure, uterine balloon tamponade is an efficient alternative, with increasing applicability in clinical practice. These devices are safe, have a low incidence of adverse events and reduce the overall rates of surgical procedures. There is a wide variety of models, both industrial and artisanal, with an accumulation of reports in the literature demonstrating their effectiveness. This article describes the main intrauterine balloons, with an emphasis on newer models, applicability, success rates and adverse events.(AU)

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.

Postpartum infection, pain and experiences with care among women treated for postpartum hemorrhage in three African countries: A cohort study of women managed with and without condom-catheter uterine balloon tamponade.

OBJECTIVE: We aimed to determine the risk of postpartum infection and increased pain associated with use of condom-catheter uterine balloon tamponade (UBT) among women diagnosed with postpartum hemorrhage (PPH) in three low- and middle-income countries (LMICs). We also sought women's opinions on their overall experience of PPH care. METHODS: This prospective cohort study compared women diagnosed with PPH who received and did not receive UBT (UBT group and no-UBT group, respectively) at 18 secondary level hospitals in Uganda, Egypt, and Senegal that participated in a stepped wedge, cluster-randomized trial assessing UBT introduction. Key outcomes were reported pain (on a scale 0-10) in the immediate postpartum period and receipt of antibiotics within four weeks postpartum (a proxy for postpartum infection). Outcomes related to satisfaction with care and aspects women liked most and least about PPH care were also reported. RESULTS: Among women diagnosed with PPH, 58 were in the UBT group and 2188 in the no-UBT group. Self-reported, post-discharge antibiotic use within four weeks postpartum was similar in the UBT (3/58, 5.6%) and no-UBT groups (100/2188, 4.6%, risk ratio = 1.22, 95% confidence interval [CI]: 0.45-3.35). A high postpartum pain score of 8-10 was more common among women in the UBT group (17/46, 37.0%) than in the no-UBT group (360/1805, 19.9%, relative risk ratio = 3.64, 95% CI:1.30-10.16). Most women were satisfied with their care (1935/2325, 83.2%). When asked what they liked least about care, the most common responses were that medications (580/1511, 38.4%) and medical supplies (503/1511, 33.3%) were unavailable. CONCLUSION: UBT did not increase the risk of postpartum infection among this population. Women who receive UBT may experience higher degrees of pain compared to women who do not receive UBT. Women's satisfaction with their care and stockouts of medications and other supplies deserve greater attention when introducing new technologies like UBT.

Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device.

BACKGROUND: Postpartum hemorrhage is a leading cause of maternal mortality globally. A tamponade agent that can be quickly and easily placed in a range of settings could advance the treatment of atonic hemorrhage. METHOD: We adapted a highly effective trauma dressing for use in postpartum hemorrhage. This mini-sponge tamponade device is comprised of two components: compressed mini-sponges contained within a strong mesh pouch and a tubular applicator. Compressed mini-sponges rapidly absorb blood, expand within seconds, and exert sustained pressure uniformly to bleeding sites. The sponges are deployed within a mesh pouch to facilitate simple vaginal removal. EXPERIENCE: We successfully placed the mini-sponge device in nine patients experiencing postpartum hemorrhage after vaginal birth, with resolution of bleeding within 1 minute. The mean time to place the device was 62 seconds. Uterine fill was documented in all cases by ultrasound scan, and device placement was rated as "easy" to "very easy." Mini-sponges were left in place on average for 1 hour (0.5 hours-14 hours). Bleeding did not recur. There were no adverse events; all patients remained afebrile and did not require subsequent surgical intervention. CONCLUSION: This study supports further evaluation of the mini-sponge device for the management of postpartum hemorrhage. FUNDING: This study was funded by OBSTETRX, Inc.

Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.

Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial.

BACKGROUND: To evaluate the effectiveness and safety of a newly designed intrauterine double-balloon catheter to arrest postpartum hemorrhage (PPH) following cesarean delivery (CD) for placenta previa. METHODS: We conducted an open-label, multicenter randomized controlled trial in two referral centers and one general hospital. Women with continuous bleeding after placental delivery following CD for placenta previa, who failed to respond to uterotonics, suturing and uterine devascularization, and in the absence of suspected deeply invasive accreta were eligible subjects. Eligible subjects were randomized to receive intrauterine double-balloon catheter (n = 102) or gauze packing (n = 102). The main outcome was the rate of successful hemostasis without the need for additional surgical interventions. The secondary outcomes included the volume of blood loss during and after CD, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, surgical complications, intensive care unit admission, need for re-laparotomy, length of hospital stay, and readmission. RESULTS: The 224 participants were recruited before delivery, with 20 excluded (14 cases bleeding stopped after uterotonics and/or local myometrium sutures and 6 patients with placental increta). Finally, 102 women were assigned in catheter group and 102 others in gauze group. There was no difference in the rate of successful hemostasis in the catheter and gauze groups (93.1% vs 91.2%, P = .80). Compared with those in the gauze group, women in the catheter group showed significantly less blood loss within 24 hours postpartum (895 [612.3-1297.8] vs 1156 [882.5-1453.3] ml, P < .01), lower rate of PPH ≥1000 ml (42.2% vs 63.7%, P < .01). Accordingly, women in the catheter group had significantly less maternal adverse events such as postpartum anemia, puerperal morbidity, and postpartum pain. CONCLUSION: Uterine tamponade using a double-balloon catheter was as effective as gauze packing in hemostasis, and appeared to be superior in reducing postpartum blood loss and pain following CD for placenta previa. Using double-balloon catheter in managing PPH in this situation may be a preferable alternative to minimize maternal morbidity.

A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.

The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial.

OBJECTIVE: To assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings. DESIGN: Stepped wedge, cluster-randomised trial. SETTING: Eighteen secondary-level hospitals in Uganda, Egypt and Senegal. POPULATION: Women with vaginal delivery from October 2016 to March 2018. METHODS: Use of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect). MAIN OUTCOME MEASURES: Combined IR of PPH-related invasive surgery and/or maternal death. RESULTS: There were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods. CONCLUSIONS: Introduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role. TWEETABLE ABSTRACT: Stepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death.

Novel intrauterine balloon tamponade systems for postpartum hemorrhage.

INTRODUCTION: Postpartum hemorrhage is the most common cause of maternal death worldwide. Although intrauterine balloon tamponade has been widely used as an effective procedure to control atonic postpartum hemorrhage, intrauterine balloon tamponade fails to control postpartum hemorrhage in approximately one-fifth of cases. The aim of this study was to evaluate the efficacy of novel intrauterine balloon tamponade systems for postpartum hemorrhage. MATERIAL AND METHODS: We have developed two novel intrauterine balloon tamponade systems to maintain proper balloon placement. One was a shaft cover with its fixture system and the other was "the Kyoto balloon system" designed to provide direct pressure onto the upper uterine cavity. The efficacy of the intrauterine balloon tamponade systems was evaluated using a silicone three-dimensionally printed postpartum uterine cavity model. RESULTS: Measurements of balloon displacement during inflation showed that the shaft cover significantly prevented the Bakri balloon from being displaced. The residual fluid volume in the upper uterine cavity was significantly less with the Kyoto balloon system than with the Bakri balloon system, indicating the effectiveness of the Kyoto balloon for upper uterine cavity tamponade. CONCLUSIONS: These innovative intrauterine balloon tamponade systems were effective for prevention of balloon displacement and for balloon tamponade of the upper uterine cavity in a 3D-printed postpartum-specific uterine cavity model.

Implementation of Low-Cost Obstetric Hemorrhage Simulation Training Models for Resident Education.

INTRODUCTION: Simulation is beneficial training for low frequency high acuity events such as management of obstetric hemorrhage. Our objective was to evaluate perceived competency in management of obstetric and pelvic hemorrhage following training with low fidelity task trainers using inexpensive and common medical supplies. MATERIALS AND METHODS: This was a prospective observational study of training residents for management of obstetric and pelvic hemorrhage using a brief didactic instruction and low-cost task trainers with inexpensive common medical supplies. Participants practiced placement of a uterine tamponade balloon, uterine packing with gauze, pelvic parachute packing and temporary abdominal closure. Following training, participants completed a self-report survey regarding perceived competency with each technique. The Wilcoxon Signed-Rank Test was used to compare results before and after training. RESULTS: Eighteen of 23 residents completed the training and completed the survey on perceived competencies. There was a statistically significant improvement in perceived competency for all participants before and after training, with scores improving by 1.5 points for Bakri placement, from 1.94 to 3.44 (p < 0.001), improving by 1.67 points for uterine packing, from 1.78 to 3.44 (p < 0.001), improving by 1.95 for pelvic parachute packing, from 1.16 to 3.11 (p < 0.001), and improving by 1.89 for temporary abdominal closure, from 1.22 to 3.11 (p < 0.001). CONCLUSIONS: Low-cost supplies and task trainers can be utilized to simulate postpartum hemorrhage and improve perceived competency in managing obstetric and pelvic hemorrhage. Similar training programs can be used in small community programs with limited resources.

Balloon Uterine Tamponade Device After Peripartum Hysterectomy for Morbidly Adherent Placenta.

BACKGROUND: Perioperative hemorrhage is a common complication of peripartum hysterectomy for morbidly adherent placenta. We present an application of a balloon uterine tamponade device in the setting of a cesarean delivery and subsequent supracervical hysterectomy for abnormal placentation. CASE: A 33-year-old gravid woman, 6 para 3022, at 33 2/7 weeks of gestation was admitted in preterm labor, with placenta previa and suspected morbidly adherent placenta, for a planned cesarean delivery and hysterectomy. After supracervical hysterectomy, colloid resuscitation and packing failed to provide hemostasis. A transcervical balloon uterine tamponade device subsequently was placed intraperitoneally and left on tension owing to the need for further tamponade. CONCLUSION: Use of a balloon uterine tamponade device intraperitoneally posthysterectomy was associated with hemorrhage control. This application may facilitate timely management and streamlining of obstetric resources for postpartum hemorrhage.

Intraluminal pressure of uterine balloon tamponade in the management of severe post-partum hemorrhage.

AIM: Intrauterine balloon tamponade has been increasingly used for the management of post-partum hemorrhage (PPH) in recent years. However, data on the precise mechanisms and pressure required for the balloon tamponade are scanty in the literature. This study aims to review the intraluminal pressure (ILP) generated by the Bakri intrauterine balloon that is necessary to produce a 'positive tamponade test' during severe PPH. METHODS: This was a prospective cohort study. The ILP of the Bakri balloon was measured using a manometer after a positive tamponade test was clinically achieved during severe PPH (blood loss >1 L). The patient's blood pressure was recorded, and ultrasound scan was performed to verify the position of the balloon and the presence of forward flow in the uterine arteries. The main outcome measure is the ILP of the Bakri balloon required to achieve a positive tamponade test. RESULTS: Twenty patients were included for final analysis. The net ILP measured ranged from 67 to 92 mmHg, and this pressure was lower than the concurrent systolic pressure in all cases. Color Doppler confirmed positive forward flow in the uterine vessels in all cases. There were no differences in the pressure measured with the balloon position, and there was no relationship between the volumes of saline infused and the net pressure. CONCLUSION: A positive tamponade test in an intrauterine balloon is probably achieved by local compression pressure exerted on the vasculature of the placental bed rather than by generating an ILP exceeding systemic blood pressure or by occlusion of flow to the uterine arteries.

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.