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Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MassachusettsDepartment of Internal Medicine, Boston Medical Center, Boston, Massachusetts
Perinatology Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health/Department of Health and Human Services, Bethesda, Maryland, and Detroit, Michigan
Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MassachusettsDepartment of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas (SP), Brazil
Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, MassachusettsHarvard Medical School, Boston, MassachusettsHarvard T.H. Chan School of Public Health, Boston, Massachusetts
To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage.
Study Design
We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm.
Results
Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9–87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02–16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14–0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage–related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%).
Conclusion
Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use.
Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017.
Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017.
Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
The prevalence of PPH has progressively increased in HICs. A Canadian population-based study reported a 27% increase in the rate of PPH from 2000 to 2009,
This study was conducted to evaluate the efficacy, effectiveness, and safety of uterine balloon tamponade for the management of postpartum hemorrhage.
Key findings
The overall pooled success rate of uterine balloon tamponade in the treatment of postpartum hemorrhage was 85.9%. The success rate was higher in women with postpartum hemorrhage due to uterine atony and placenta previa than in women with postpartum hemorrhage due to placenta accreta spectrum or retained products of conception. The frequency of complications associated with the use of uterine balloon tamponade was low. To date, uterine balloon tamponade appears to have no adverse consequences on subsequent reproductive function.
What does this add to what is known?
Findings from this study indicate that uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage with a low complication rate. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies.
Predisposing factors and etiologies for PPH include multiple pregnancy, fetal macrosomia, abnormal placentation, grand multiparity, older age, obesity, rapid or prolonged labor, labor induction, cesarean delivery, chorioamnionitis, uterine atony, retained placenta, genital tract lacerations, retained products of conception, and coagulation disorders, among others.
Evidence-based guidelines for the management of abnormally invasive placenta: recommendations from the International Society for Abnormally Invasive Placenta.
Appropriate treatment of PPH includes uterine massage, uterotonics, tranexamic acid, and, in cases of refractory bleeding, uterine balloon tamponade (UBT), uterine arterial embolization, and other surgical procedures.
Access to these critical interventions is often lacking in low-resource settings and therefore contributes to the high morbidity and mortality rates attributed to PPH.
Compared to other interventions used to treat refractory PPH, UBT requires minimal local resources and does not entail extensive training or complex equipment. UBTs can be used by a variety of healthcare providers and are recently becoming more affordable.
Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.
However, uncertainty still exists regarding the evidence on the efficacy of UBT for the management of PPH.
A systematic review published in 2013, including 13 observational studies with a total of 241 women, concluded that UBT is effective for the treatment of PPH in low-resource settings.
Since then, considerable additional research on UBT has been published, including individual and cluster randomized trials and before-and-after studies of effectiveness. Therefore, examination of the current evidence on the efficacy of this intervention is justified. We conducted a systematic review and meta-analysis to determine the efficacy, effectiveness, and safety of UBT for the treatment of PPH.
Materials and Methods
This systematic review and meta-analysis was performed and reported according to the PRISMA statement.
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.
The protocol was registered with PROSPERO in July 2018 (CRD42018102643; available at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=102643). At least 2 of the authors (S.S., D.S.R., and A.B.P.) independently retrieved and reviewed studies for eligibility, assessed their risk of bias, and extracted data. Any disagreements encountered in the review process were resolved through discussion between the reviewers.
Literature search
A literature search was conducted by Harvard library services. PubMed, Ovid MEDLINE, EMBASE, POPLINE, Web of Science, African Index Medicus, LILACS/BIREME, Cochrane Library, and Google Scholar were searched from their inception to August 31, 2019, using a combination of terms related to PPH and UBT (Appendix: I. Search Strategy), without language restrictions. Reference lists of identified studies were also searched.
Eligibility criteria
Randomized controlled trials (RCTs), nonrandomized studies of interventions, and case series that reported on efficacy, effectiveness, and/or safety of UBT device placement in women with PPH after vaginal and/or cesarean delivery were included. Studies were excluded if they (1) reported on surgical techniques simultaneous with UBT use (eg, B-Lynch suture plus UBT); (2) were case reports, editorials, letters to the editors, or reviews without original data; or (3) reported on use of UBT for hemorrhage associated with pregnancy loss before 20 weeks of gestation. Studies with cases of UBT placement after failure of a surgical procedure for PPH were included. In cases of duplicate publications, only the most recent or complete version was included.
Outcome measures
The primary outcome was the success rate of UBT for the treatment of all causes of PPH. UBT success rate was defined as the number of “UBT success” cases divided by the total number of women treated with UBT, regardless of the definition of UBT success in each individual study. Cases of PPH where bleeding was arrested without maternal death and additional surgical or radiological interventions after UBT placement were defined as “UBT success.” Cases of PPH where maternal death occurred or where additional surgical or radiological interventions were performed were defined as “UBT failures.” For randomized trials and nonrandomized studies, the primary outcome was a composite of maternal death and/or surgical (artery ligation, uterine compression sutures, or hysterectomy) or radiological (arterial embolization) interventions. Secondary outcomes included success rate of UBT for the treatment of individual causes of PPH, frequency of hysterectomy and other invasive procedures (artery ligation, uterine compressive sutures, and arterial embolization), maternal death, mean blood loss, blood loss >1000 mL, blood transfusion, mean change in hemoglobin and hematocrit, admission to the intensive care unit, length of hospital and intensive care unit stay, and complication rates. Complications were defined as undesirable and unintended events that were likely a direct result of UBT placement, such as infection, trauma, or reproductive consequences.
Risk of bias assessment
The risk of bias of included RCTs, nonrandomized studies, and case series was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions,
A data extraction form was used to collect information on study characteristics (authors, year of publication, design, prospective or retrospective data collection, definition of PPH, risk of bias, and method of assessment of blood loss); setting (country, income level, urban vs rural, number of facilities, and facility type); patient characteristics (inclusion and exclusion criteria, type of delivery, cause of PPH, baseline characteristics, and date of recruitment); details of intervention (type of UBT device, indication for UBT use, time of UBT placement, volume of fluid placed in UBT device, duration of placement, time to UBT device removal, and co-interventions); and outcomes (definitions used, number of outcome events/total number, and mean ± standard deviation for each outcome). Results from different studies were combined to produce a pooled success rate with 95% confidence interval (CI) using random-effects models. For RCTs and nonrandomized studies, estimates of success rate were obtained from the UBT intervention group only. Results were stratified according to study design, mode of delivery, and cause of PPH. Subgroup analyses were performed according to UBT device (Bakri balloon vs condom UBT) and stratified by cause of PPH (all causes of PPH vs uterine atony) and income (HICs vs LMICs). Sensitivity analyses were performed based on risk of bias and inclusion of data from abstracts of studies published only in abstract form or unobtainable articles.
Estimates of treatment effect were obtained from meta-analyses of RCTs and nonrandomized studies. These analyses compared the results of patients who were treated with UBT devices with those of a control group that was not treated with UBT devices. We calculated the pooled relative risk (RR) for dichotomous data and mean difference (MD) for continuous data with an associated 95% CI. If means were not reported in individual studies, we estimated them using the sample size, median, and interquartile ranges.
We pooled results from individual studies using a fixed-effects model if substantial statistical heterogeneity was not present (I2 < 30%). If I2 values were ≥30%, a random-effects model was used to pool data across studies.
We assessed the overall quality of the evidence using the GRADE approach
for the following outcomes: composite of maternal death and/or surgical or radiological interventions, maternal death, surgical interventions, hysterectomy, artery ligation, uterine compressive sutures, and arterial embolization. GRADE has 4 levels of evidence: high, moderate, low, and very low (Appendix: III. Quality of Evidence).
Descriptive statistical analyses were performed using RStudio version 1.0.153 (RStudio, Inc, Boston, MA). Meta-analyses were conducted using MedCalc version 19.03 (MedCalc Software, Ostend, Belgium) and Review Manager 5.3.5 (The Nordic Cochrane Centre, Copenhagen, Denmark).
Results
Study selection and characteristics
We identified 3653 studies in our literature search, of which 644 met initial screening criteria and were further assessed for eligibility (Figure 1). Ninety-one studies including a total of 4729 women met inclusion criteria, of which 6 were RCTs,
Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.
Bakri balloon versus condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial.
Efficacy and safety of intrauterine balloon tamponade versus uterovaginal roll gauze packing in patient presenting with primary postpartum hemorrhage after normal vaginal delivery.
Annals of King Edward Medical University.2018; 24: 889-892
The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum hemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomized trial.
Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage.
Comparison between two management protocols for postpartum hemorrhage during cesarean section in placenta previa: balloon protocol versus non-balloon protocol.
Various modifications of condom balloon tamponade and their method, efficacy, outcomes in management of atonic postpartum hemorrhage in tertiary care centre- a observational study.
Journal of Medical Science and Clinical Research.2018; 6: 482-489
Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade.
Experience with different techniques for the management of postpartum hemorrhage due to uterine atony: compression sutures, artery ligation and Bakri balloon.
Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.
Hemostatic effect of intrauterine balloon for postpartum hemorrhage with special reference to concomitant use of “holding the cervix” procedure (Matsubara).
had control groups that precluded their analysis as nonrandomized studies, but these studies provided data as case series. The corresponding authors of 2 studies were contacted to obtain additional information on relevant unpublished data.
The main characteristics of the studies included in the systematic review are presented in Supplementary Table 1 (Appendix). Forty-six studies (52%) were conducted in 12 Asian countries,
Efficacy and safety of intrauterine balloon tamponade versus uterovaginal roll gauze packing in patient presenting with primary postpartum hemorrhage after normal vaginal delivery.
Annals of King Edward Medical University.2018; 24: 889-892
Comparison between two management protocols for postpartum hemorrhage during cesarean section in placenta previa: balloon protocol versus non-balloon protocol.
Various modifications of condom balloon tamponade and their method, efficacy, outcomes in management of atonic postpartum hemorrhage in tertiary care centre- a observational study.
Journal of Medical Science and Clinical Research.2018; 6: 482-489
Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade.
Experience with different techniques for the management of postpartum hemorrhage due to uterine atony: compression sutures, artery ligation and Bakri balloon.
Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.
Hemostatic effect of intrauterine balloon for postpartum hemorrhage with special reference to concomitant use of “holding the cervix” procedure (Matsubara).
Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage.
Bakri balloon versus condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial.
Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.
The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum hemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomized trial.
Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.
Bakri balloon versus condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial.
Efficacy and safety of intrauterine balloon tamponade versus uterovaginal roll gauze packing in patient presenting with primary postpartum hemorrhage after normal vaginal delivery.
Annals of King Edward Medical University.2018; 24: 889-892
The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum hemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomized trial.
Various modifications of condom balloon tamponade and their method, efficacy, outcomes in management of atonic postpartum hemorrhage in tertiary care centre- a observational study.
Journal of Medical Science and Clinical Research.2018; 6: 482-489
Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade.
Experience with different techniques for the management of postpartum hemorrhage due to uterine atony: compression sutures, artery ligation and Bakri balloon.
Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.
Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage.
Comparison between two management protocols for postpartum hemorrhage during cesarean section in placenta previa: balloon protocol versus non-balloon protocol.
Hemostatic effect of intrauterine balloon for postpartum hemorrhage with special reference to concomitant use of “holding the cervix” procedure (Matsubara).
The median number of women treated with a UBT device for PPH was 64 (range, 7–120), 40 (range, 13–142), and 29 (range, 4–407) for RCTs, nonrandomized studies, and case series, respectively. The most-used UBT devices were Bakri balloon and condom catheter (Figure 2), which were used in 44 (49%) studies,
Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage.
Comparison between two management protocols for postpartum hemorrhage during cesarean section in placenta previa: balloon protocol versus non-balloon protocol.
Experience with different techniques for the management of postpartum hemorrhage due to uterine atony: compression sutures, artery ligation and Bakri balloon.
Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.
Hemostatic effect of intrauterine balloon for postpartum hemorrhage with special reference to concomitant use of “holding the cervix” procedure (Matsubara).
Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.
Efficacy and safety of intrauterine balloon tamponade versus uterovaginal roll gauze packing in patient presenting with primary postpartum hemorrhage after normal vaginal delivery.
Annals of King Edward Medical University.2018; 24: 889-892
The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum hemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomized trial.
Various modifications of condom balloon tamponade and their method, efficacy, outcomes in management of atonic postpartum hemorrhage in tertiary care centre- a observational study.
Journal of Medical Science and Clinical Research.2018; 6: 482-489
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