A new study summarizing and reanalyzing the .
Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.
In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.
Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.
“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.
One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.
UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.
Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.
The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.
To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.
The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.
Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.
Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.
Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”
“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”
Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”
The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.
SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.