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

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

Implementation of a guideline of early administration of tranexamic acid for severe primary postpartum haemorrhage: a retrospective comparative study.

BACKGROUND: Since the WOMAN trial, intravenous tranexamic acid (TXA) has been increasingly used in severe postpartum haemorrhage (PPH) but research evaluating use in high-income settings is limited. AIMS: To assess whether implementation of a new guideline involving early administration of 1 g intravenous TXA in active PPH with blood loss ≥ 1000 mL, was associated with a change in maternal morbidity. MATERIALS AND METHODS: Retrospective study of all singleton, term, vaginal births from November 2016 to June 2019 with a PPH of ≥1000 mL, before and after hospital adoption of a guideline recommending early (within three hours of birth) administration of TXA for women with active PPH ≥ 1000 mL. Univariate analysis assessed the impact of this guideline implementation on a primary outcome of maternal morbidity, defined as one or more of haemoglobin < 90 g/L, administration of blood products, hysterectomy or intensive care admission. Secondary outcomes were adverse events related to administration of TXA, use of an intrauterine balloon or postpartum iron infusion. RESULTS: There was no difference in morbidity (odds ratio (OR) 0.86, 95% CI 0.57-1.29, P = 0.46) or postpartum iron infusion (OR 1.44, 95% CI 0.92-2.27, P = 0.11), but there was a reduction in the use of intrauterine balloon tamponade after the implementation of the TXA guideline (OR 0.33, 95% CI 0.16-0.67, P < 0.01). CONCLUSIONS: This retrospective analysis showed a reduced use of intrauterine balloon but failed to show a benefit in maternal morbidity with early administration of TXA for severe postpartum haemorrhage in a high-income setting.

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.

Pregnancy outcomes of patients with acute fatty liver of pregnancy: a case control study.

BACKGROUND: Limited data exists regarding the pregnancy and infant outcomes of Acute Fatty Liver of Pregnancy (AFLP). METHODS: Retrospectively collected mothers with AFLP and mothers without AFLP in our center from 1/2008 to 6/2018. The primary assessment was to analyze and compare the frequency of negative maternal and fetal outcomes. The secondary assessment was to investigate the role of intrauterine balloon tamponade in reducing negative maternal outcomes. RESULTS: Compared to 220 matched mothers, 55 AFLP mothers were younger (P < 0.001), with fewer pregnancies (P = 0.033), complicated with more pregnancy induced hypertension (P < 0.001), twins(P = 0.002), fetal growth restriction (P = 0.044) and male fetus (P < 0.001). 3 (5.5%) of AFLP patients were diagnosed in the postpartum period. Mean gestational week of AFLP diagnosis was 35.25 ± 5.80 weeks. Jaundice (89.1%), nausea or vomiting (58.2%), anorexia (49.1%), fatigue (45.5%) and polydipsia (30.9%) were the main prodromal symptoms. The median duration from diagnosis to delivery was 1.55 ± 4.62 days and 75% (39/52) pregnancy were terminated the pregnancy at the day of diagnosis. 78.8% (41/52) patients received cesarean section, 53.6% (22/41) of which received preventive plasma transfusion before surgery and no one received artificial liver support during the treatment. In comparison, higher frequency of 16 maternal complications, severe negative outcomes (27.3% vs. 0.9%) and newborn asphyxia (24.6% vs.0.9%) were observed in AFLP population. 3 mothers (mortality rates: 5.5%) died of multiple organ system failure and 6 fetus/infants (death rates: 9.8%) died of distress. When compared to those without negative outcomes, patients with negative fetal outcomes were younger (P = 0.042), had more singleton rates (p = 0.041), increased mean value of ALT(P = 0.011) and T-Bilirubin (P = 0.014), decreased prothrombin activity (P = 0.011). Although no statistical significance for the small sample size, there were less refractory postpartum hemorrhage (0% vs.31.3%), hysterectomy (0% vs.12.5%), negative maternal outcomes (16.7% vs.56.3%) in patients underwent intrauterine balloon tamponade when postpartum hemorrhage exceeded 500 ml. CONCLUSIONS: Several symptoms were found to be the main prodromal symptoms of AFLP. Higher frequency of adverse maternal and fetal outcomes was observed in mothers with AFLP than mothers without AFLP. We found five potential risk factors of negative fetal outcomes.

[Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion in the management of women with placenta accreta spectrum:a randomized controlled trial].

Objective: To access the effectiveness and safety of the intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion in the management of placenta accreta spectrum (PAS). Methods: This was an open-label, randomized controlled trial conducted in Nanjing Drum Tower Hospital. The patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018. When bleeding could not be achieved after fetus delivered, and a temporary abdominal aortic balloon occlusion and the compression sutures as needed, the women were randomly allocated 1∶1 into balloon tamponade (n=81) or gauze packing (n=80) group. The primary outcome was successful bleeding arrests by avoiding second line surgeries. The secondary outcomes included the volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications. Results: All the women [100% (81/81)] in the balloon group were obtained hemostasis without further intervention, significantly higher than 88% (70/80) in the gauze group (P=0.001). Before uterine tamponade, blood loss were 820 ml (620-1 230) ml and 850 ml (605-1 442) ml, while placenta bed were sutured in 96%（78/81, 77/80） respectively (P>0.05).The proportion of blood loss≥1 000 ml was higher in the gauze group than that in the balloon group (P=0.006). Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain occurred more frequently in the gauze group (P<0.05). The following outcome showed no statistically significant difference between the two groups: the vascular occlusion time, the dose of radiation, and interventional radiology complication (P>0.05). The median volume infused into the lower and upper balloons is 70 ml (50-100 ml) and 180 ml (100-240 ml). Conclusions: Incrauterine balloon tamponade is as effective as gauze packing in hemostasis following the placenta delivery in PAS. Compared with gauze packing, the uterine balloon tamponade is more effective.

Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score-matched cohort study.

INTRODUCTION: The aim of this study was to compare the outcomes of women who were initially managed by intrauterine balloon tamponade or uterine artery embolization because of persistent postpartum hemorrhage demanding an immediate intervention to control bleeding. MATERIAL AND METHODS: Propensity score-matched cohort study including women who had intrauterine balloon tamponade or uterine artery embolization as initial management strategy to control persistent postpartum hemorrhage, that is, refractory to first-line therapy combined with at least one uterotonic agent. The primary outcome measure was a composite of peripartum hysterectomy and/or maternal mortality. Secondary outcomes measures were total volume of blood loss and total number of packed red blood cells transfused. RESULTS: Our 1:1 propensity score-matched cohort comprised of 50 women who had intrauterine balloon tamponade and 50 women who underwent uterine artery embolization at a blood loss between 1000 and 7000 mL. There was no statistically significant difference in the hysterectomy risk between the two groups (n = 6 in each group, odds ratio [OR] 1.00, 95% confidence interval [CI] .30-3.34), in total volume of blood loss (median 4500 mL, interquartile range [IQR] 3600-5400) for balloon vs 4000 mL (IQR 3250-5000) for embolization, P = 0.382) or in total units of packed red blood cells transfused (median 7 (IQR 5-10) for balloon vs 6 [IQR 4-9] for embolization, P = 0.319). Fifteen women (30%) who were initially managed by an intrauterine balloon still underwent uterine artery embolization, of whom one had an embolization-related thrombo-embolic event. Maternal mortality occurred in neither of the intervention groups. CONCLUSIONS: No difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as an initial management for persistent postpartum hemorrhage. Although this study was underpowered to demonstrate equivalence, our study design provides a framework for future research in which intrauterine balloon tamponade may prove to be a suitable intervention of first choice in the management of persistent postpartum hemorrhage.

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

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

The association between intrauterine balloon tamponade duration and postpartum hemorrhage outcomes.

BACKGROUND: Intrauterine balloon tamponade is an effective treatment for postpartum hemorrhage when first-line treatments fail. The optimal duration of intrauterine balloon tamponade for management of postpartum hemorrhage is unclear. OBJECTIVE: The objective of the study was to determine whether intrauterine balloon tamponade removal >12 hours of duration is associated with postpartum hemorrhage-related clinical outcomes. STUDY DESIGN: This was a retrospective cohort study of women with postpartum hemorrhage from 2007 through 2014 who underwent intrauterine balloon tamponade. We excluded failures of intrauterine balloon tamponade (intrauterine balloon expulsion with duration <2 hours or if hysterectomy was required prior to planned intrauterine balloon removal). Patients who underwent intrauterine balloon tamponade for 2-12 hours were compared with those who underwent intrauterine balloon tamponade for >12 hours. Examined postpartum hemorrhage-related clinical outcomes included estimated blood loss after intrauterine balloon tamponade placement, blood product transfusion, use of adjuvant measures to control postpartum hemorrhage after intrauterine balloon tamponade (either uterine artery embolization or hysterectomy), and maternal intensive care unit admission. Secondary outcomes examined included postpartum fever and hospital length of stay. Multivariable logistic regression models were used to control for confounding variables. RESULTS: Of 274 eligible women, 206 (75%) underwent intrauterine balloon tamponade for >12 hours and 68 (25%) underwent intrauterine balloon tamponade for 2-12 hours. The median estimated blood loss after intrauterine balloon tamponade placement (190 vs 143 mL, P = .116) as well as the frequencies of blood product transfusion (62.1% vs 51.5%, P = .120), transfusion of ≥4 U of packed red blood cells (17.0% vs 14.7%, P = .659), uterine artery embolization (15.1% vs 16.2%, P = .823), hysterectomy (0.0% vs 1.5%, P = .248), and intensive care unit admission (8.7% vs 7.4%, P = .721), was not statistically different between the groups, and this lack of association persisted in multivariable regressions. Intrauterine balloon tamponade duration >12 hours was associated with a higher frequency of postpartum fever (27% vs 15%, P = .047) and a longer mean hospital length of stay (3.7 vs 3.1 days, P = .002). After adjusting for variables that differed statistically between groups, the difference in length of stay associated with intrauterine balloon tamponade duration was no longer present, but the association between intrauterine balloon tamponade duration >12 hours and postpartum fever persisted (odds ratio, 2.33, 95% confidence interval, 1.07-5.11). Including chorioamnionitis as an independent variable in a post hoc multivariable analysis diminished the association between intrauterine balloon tamponade >12 hours and postpartum fever (adjusted odds ratio, 2.04, 95% confidence interval, 0.92-4.53). CONCLUSION: There are no significant differences in postpartum hemorrhage-related outcomes associated with intrauterine balloon tamponade duration >12 hours compared with removal 2-12 hours. If ongoing hemorrhage has abated, it is reasonable to consider the removal of an intrauterine balloon by 12 hours after its initial placement.

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.

Treatment decision-making for post-partum hemorrhage using dynamic contrast-enhanced computed tomography.

AIM: Post-partum hemorrhage (PPH) is the leading cause of maternal mortality. Identification of the precise bleeding site is generally important to control hemorrhage, but such an approach has not been fully established in the context of PPH. We postulated that visualization of bleeding sites could aid treatment decisions in the management of PPH. METHODS: We conducted a prospective review of 26 patients who underwent dynamic computed tomography (CT) for PPH. RESULTS: A total of 17 cases presented with uterine bleeding, eight with vaginal hematomas, and one with hemoperitoneum. Overall, dynamic CT identified contrast media extravasation in the arterial phase in 12 of 26 (46.2%) cases: the upper (n = 4) and the lower uterine segment including the cervix (n = 2), subfascial space (n = 1) and vagina (n = 5). Identification of precise arterial bleeding sites using CT provided informative guidance about where to place balloons for intractable uterine bleeding, and how to manage hemoperitoneum and vaginal hematomas. In addition, dynamic CT revealed the existence of a subtype of uterine atony, which is characterized by focal active arterial bleeding in the upper uterine segment. Furthermore, negative contrast extravasation extracted cases of PPH that were well controlled without the need for surgical or radiological intervention. No patient required emergency hysterectomy to control PPH. CONCLUSION: Dynamic CT has potential clinical utility in treatment decision-making for PPH.

Timely use of Bakri intrauterine balloon tamponade contributes to the effectiveness in controlling severe postpartum hemorrhage.

The aim of the present study was to explore the effectiveness of Bakri intrauterine balloon tamponade (IUBT) in treating severe postpartum hemorrhage (SPPH). A cohort of 198 women with SPPH using IUBT were retrospectively selected. The baseline and maternal outcome characteristics were examined. The results demonstrated that women with SPPH had a high proportion of placenta accrete (53.0%). Bakri IUBT demonstrated a global effectiveness of 84.5% in SPPH treatment, accounting for 82.9% in women with placenta accrete. Compared with women with Bakri failure, women who experienced Bakri success had reduced rates of less use of pre-/post-IUBT intervention, blood transfusion, lower genital tract trauma, estimated blood loss (EBL), and a longer indwelling duration (P<0.05). Logistic regression revealed that the pre-IUBT intervention (OR=3.910; 95% CI: 1.684-9.079; P=0.002) was positively associated with hemostasis success, while lower genital tract trauma was negatively associated with Bakri success (OR=0.091; 95% CI: 0.009-0.894; P=0.040). Moreover, women diagnosed with placenta accrete underwent a greater number of transabdominal placed Bakri IUBT and pre-IUBT interventions than those without placenta accrete (P<0.05). No significant differences were observed in Bakri success, total EBL, pre-/post-IUBT EBL, infused volume of IUBT, IUBT indwelling duration, even the rate of hemostasis, lower genital tract trauma, blood transfusion, post-IUBT intervention, and puerperal fever between women with and without placenta accrete (P>0.05). In conclusion, placenta accrete may be the leading cause of SPPH. Bakri IUBT is an effective and safe measure for SPPH. Pre-IUBT intervention may be predictive of Bakri's success. The timely use of IUBT during labor may mitigate the impact of risk factors identified on PPH.

Innovative hemostasis technique for cesarean section in placenta previa: A retrospective study.

OBJECTIVE: To evaluate hemostatic efficacy, complications, and subsequent pregnancy outcomes in women with placenta previa who underwent combined vertical compression sutures in the lower uterine segment and intrauterine balloon tamponade (Hot-Dog method) to achieve hemostasis after cesarean section. METHODS: We retrospectively reviewed data for 117 women with singleton pregnancy diagnosed with placenta previa who underwent cesarean section between 29 and 38 weeks' gestation. Treatments were as follows: (1) conventional-intravenous oxytocin administration after placental detachment and suturing of bleeding points at the detachment site as needed (conventional group) (n = 47). (2) Intrauterine balloon tamponade alone (balloon group) (n = 41). (3) Vertical compression sutures + intrauterine balloon tamponade (Hot-Dog group) (n = 29). RESULTS: The placenta accreta spectrum prevalence was significantly higher in the balloon and Hot-Dog groups versus the conventional group. The prevalence of anteriorly located placenta was significantly higher in the Hot-Dog versus balloon groups. Intraoperative and total blood loss were significantly higher in the Hot-Dog versus conventional groups. Postoperative blood loss was significantly lower in the Hot-Dog versus balloon groups. Fewer additional procedures for managing postoperative hemorrhage were required in the Hot-Dog versus conventional and balloon groups. The number of subsequent pregnancies in the conventional, balloon, and Hot-Dog groups was 11 (23.4%), 8 (19.5%), and 4 (13.8%), respectively; all resulted in live births at term without serious obstetric complications. CONCLUSION: The Hot-Dog method is a straightforward and safe hemostasis technique for placenta previa that preserves fertility and controls severe bleeding.

Cervical Cerclage to Prevent Intrauterine Balloon Prolapse.

Intrauterine balloon prolapse sometimes occurs, and the intrauterine balloon must be reinserted. Furthermore, intrauterine balloon tamponade (IBT) failure can necessitate additional invasive procedures. We report a case of cervical cerclage with IBT for placenta previa with a cervical dilation. In our case, emergency cesarean section was performed at 35 + 4 weeks of gestation because of persistent hemorrhage. During the operation, we performed IBT to prevent further postpartum hemorrhage. However, immediately after the operation, uterine cervical dilatation was 6 cm, which resulted in cervical dilation and prolapse of the intrauterine balloon. Therefore, we performed cervical cerclage using absorbable sutures with IBT and blood transfusion. We speculated that the intrauterine balloon might have induced cervical canal ripening during the operation. Our case suggested that cervical cerclage with IBT is a useful method to prevent intrauterine balloon prolapse in cases with cervical dilation.

Differential Effects of Intrauterine Balloon Tamponade Indications on Postpartum Hemorrhage Outcomes.

Objective: To determine whether the indication of intrauterine balloon tamponade (IUBT) was associated with postpartum hemorrhage (PPH) outcomes. Methods: Patients with PPH who underwent IUBT between January 2013 and November 2021 were included in a cohort study. PPH outcomes in patients who had IUBT for indications of uterine atony were compared to those who had IUBT for indications of placental site bleeding. PPH outcomes included uterine artery embolization (UAE) or hysterectomy after IUBT, estimated blood loss (EBL) after balloon placement, and blood transfusion. Statistical analysis was performed using multivariate logistic regression. Results: IUBT was performed on 603 cases, with 121 (20.1%) undergoing it for placental site bleeding and 482 (79.9%) for uterine atony. In general, IUBT was a reliable treatment for PPH, but the specific efficacy varied depending on the indication for placement. After controlling for confounding variables, compared to the indication of uterine atony, the indication of placental site bleeding increased the risk of transfusion of ≥4 units of PRBCs (aOR 2.47, 95%CI 1.32-3.98), EBL ≥ 300 ml after IUBT (aOR 3.78, 95%CI 2.22-5.33), and UAE or hysterectomy (aOR 2.52, 95%CI 1.20-6.01), respectively. Other factors associated with adverse PPH outcomes were lower antenatal hemoglobin, higher IUBT volume, longer duration of IUBT and larger shock index values. Conclusions: IUBT was less effective in treating PPH patients with indications of placental site bleeding than with indications of uterine atony. Follow-up monitoring of PPH patients with placental site bleeding should be intensified.

Predictors of Failed Intrauterine Balloon Tamponade in the Management of Severe Postpartum Hemorrhage.

To identify the factors predicting intrauterine balloon tamponade (IUBT) failure for severe postpartum hemorrhage (PPH) after delivery, we conducted a retrospective cohort study of women who underwent IUBT for severe PPH after delivery from October 1, 2016 until September 30, 2017. The failure of IUBT was defined as the need of additional surgical procedures or uterine embolization. A total of 99,650 deliveries occurred during the study period. Among the patients, 106 cases of severe PPH were managed with IUBT, and the global success rate was 70.8% (75/106). Least absolute shrinkage and selection operator (LASSO) regression was performed to select the potential risk factors predicting IUBT failure. The associated risk factors-obesity, multiple gestation, cesarean delivery, estimated blood loss (EBL), and placenta accreta spectrum (PAS)-were included in multivariate logistic models. Ultimately, these models identified multiple gestation, EBL, and PAS as independent risk factors for IUBT failure. In conclusion, IUBT is an effective method for severe PPH. The presence of factors affecting IUBT failure should be recognized early, and other modalities of management should be anticipated.

Impact of intrauterine balloon tamponade on emergency peripartum hysterectomy following vaginal delivery.

OBJECTIVE: To assess the impact of intrauterine balloon tamponade as a second-line technique before resorting to emergency peripartum hysterectomy in cases with severe postpartum hemorrhage and uterotonic treatment failure following vaginal delivery. STUDY DESIGN: A retrospective, monocentric study evaluating cases of uterotonic treatment failure with severe postpartum hemorrhage following vaginal delivery between January 2005 and June 2018. Cases of cesarean section, amniotic embolism, uterine rupture, placenta accreta, and postpartum hemorrhage by vaginal laceration were excluded. The primary study outcome was incidence of emergency peripartum hysterectomy before and after use of intrauterine balloon tamponade was initiated. RESULTS: Among the 55,776 women who gave birth vaginally at our site during the study period, 161 (0.3 %) had severe postpartum hemorrhage with medical treatment failure (78 during the period prior to intrauterine balloon tamponade use, and 83 after intrauterine balloon tamponade use was initiated). The intrauterine balloon tamponade failure rate was 21.9 % (n = 18). Emergency peripartum hysterectomy was performed in 7 cases prior to intrauterine balloon tamponade use and 2 cases during use of intrauterine balloon tamponade. Thus, we observed a nonsignificant decrease in emergency peripartum hysterectomy after use of intrauterine balloon tamponade was implemented (9.0 % vs. 2.4 %, p = 0.09). However, the decrease was significant among patients who underwent conservative surgical treatment before intrauterine balloon tamponade use (53.8 % vs. 12.5 %, p = 0.041). CONCLUSIONS: Though we did not find a significant overall reduction in emergency peripartum hysterectomy following implementation of intrauterine balloon tamponade, there was a decrease in these cases when conservative surgical treatment was followed by intrauterine balloon tamponade.

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

OBJECTIVE: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH). METHODS: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting. RESULTS: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. CONCLUSION: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Novel subtype of atonic postpartum hemorrhage: dynamic computed tomography evaluation of bleeding characteristics and the uterine cavity.

Background: Uterine atony is the leading cause of severe postpartum hemorrhage (PPH); however, the underlying cause of intractable atonic PPH unresponsive to conventional treatments (such as uterotonics and intrauterine balloon tamponade) remains unclear.Objectives: The aim of this study was to investigate whether intractable atonic PPH is associated with the type of bleeding (arterial or nonarterial) and its location, along with variations in the size and shape of the uterine cavity after delivery.Study design: This retrospective study included women who had undergone a dynamic computed tomography (CT) scan for the management of severe PPH at Kyoto University Hospital between April 2011 and March 2017. Patients' electronic medical records were reviewed, and relevant clinical information was collected. The presence of contrast extravasation (CE) on CT images in the early phase (40 s) was regarded as active arterial bleeding. Bleeding sites and size of the uterine cavity were evaluated using an xyz coordinate system. The size of the uterine cavity was compared between groups with CE into the upper and lower parts of the uterine body.Results: Of the 60 women assessed for eligibility, 30 were included in the current analysis. Contrast extravasation was detected in 19 women, with 14 showing CE in the early phase. The presence of CE in the early phase was significantly associated with the need for transarterial embolization (Fisher's exact test, p = .0017). The upper and lower parts of the uterine cavity were 97.4 ± 2.7 mm (mean ± standard error of the mean) and 87.2 ± 3.5 mm in length, respectively. The maximum anteroposterior diameters of the upper and lower parts of the uterine cavity were 23.1 ± 2.6 and 76.0 ± 3.0 mm, respectively, and the largest transverse diameters were 67.3 ± 1.9 and 81.1 ± 2.3 mm, respectively. The group that showed CE into the upper uterine cavity had significantly larger qualitative parameters of the upper uterine cavity compared to the group with CE into the lower uterine cavity. The gate from the lower uterine cavity toward the upper uterine cavity was narrow (anteroposterior diameter of 22.6 ± 2.0 mm, transverse diameter of 40.7 ± 3.3 mm), and the intrauterine balloon was always found in the lower uterine cavity on the CT scan. The upper uterine body was characterized by a flat oval-shaped cavity (xy plane), thick uterine wall, and lack of uniformity among bleeding sites (z = 62.4 ± 14.8 mm). In contrast, the lower uterine cavity was a circular shape (xy plane) with thin walls, and bleeding sites were located at lateral sides around the level of the internal os (z = -18.8 ± 4.9 mm).Conclusions: Atonic PPH has a significant subtype, named "PRACE," which is characterized by PPH, resistance to treatment, and arterial CE. The need for embolization can be predicted by the presence of arterial bleeding and its location, along with the shape of the uterine cavity.

Bilateral cervix apex clamping procedure can be used as a new noninvasive second line therapy for postpartum hemorrhage.

In this study, we present a noninvasive procedure of bilateral cervix apex clamping (BCAC) procedure to control refractory postpartum hemorrhage (PPH) in vaginal delivery as a new second line therapy for refractory PPH. The procedure clamps the anterior and posterior walls of the cervical apex using toothless ovum forceps to arrest bleedingafter the failure of the first line therapy for PPH. 44 women were performed BCAC to control persistent bleeding in 13,359 vaginal deliveries from 1 January 2016 to 31 May 2018. In all of the BCAC, it can reduce bleeding significantly. The bleeding speed after BCAC was far less than that before it (2.64 ± 4.99 ml/min vs 20.23 ± 9.40 ml/min P < 0.001). The blood loss after BCAC was less than that before it (146.57 ± 170.83 vs 797.84 ± 200.73 ml P < 0.001). 41 (93.2%) BCACsucceeded and 3(6.8%) failed turned to intrauterine balloon tamponade, 2 succeeded and 1 failed turned to hysterectomy. In the successful group the bleeding speed after the BCAC was 1.38 ± 0.99 ml/min less than that 19.84 ± 6.27 ml/min in the failure group. (p < 0.001). The blood loss in the success group is also less than that in the failure ones after BCAC (107.29 ± 78.36mL vs 683.33 ± 202.07 ml P < 0.001) Even in the failure group, the bleeding speed also reduced after BCAC compared with that before BCAC (19.84 ± 6.27 vs 29.17 ± 7.12 ml/min p = 0.02). But the blood loss had no statistical difference (683.33 ± 202.07 vs 950 ± 132.29 ml p = 0.27) In all of the 13,359 vaginal deliveries, the incidence of PPH was 1.21% while the severe PPH was only 0.27%. The BCAC may reduce the incidence of severe PPH (0.27%) and also can reduce the necessity of IUBT (3/13,359 0.22‰), uterine artery embolization (UAE) (0/13,359) and even the exploratory laparotomy hysterectomy (1/13,359). Because it is effective, convenient, cheap and noninvasive, so we think it can be used as a new second line noninvasive treatment for PPH.

Application of chitosan-covered gauze in combination with intrauterine balloon tamponade for postpartum hemorrhage treatment - Case report of a novel "uterine sandwich" approach.

INTRODUCTION: Postpartum or peripartum hemorrhage (PPH) is a major cause of maternal death worldwide. Fertility preserving second stage interventions following uterotonic medications may include compression sutures, uterine balloon tamponade and ligation or embolization of arteries. PRESENTATION OF CASE: We present a case of PPH where a novel "uterine sandwich" approach (combination of chitosan-covered gauze with intrauterine balloon tamponade) was effectively used to stop further blood loss and prevented more invasive second stage interventions. Furthermore, we present the ultrasonographic image of chitosan-covered gauze in the uterine cavity. DISCUSSION: Chitosan-covered gauze and intrauterine balloon tamponade are complementary in their mechanism of work, the balloon reducing blood flow into the uterus and the chitosan-covered gauze enhancing the coagulation. CONCLUSION: This novel "uterine sandwich" approach can be a useful method for fertility preserving management of PPH.