Inexpensive device shows high success rate for stopping bleeding with low complication rate
FRIDAY, Jan. 10, 2020 (HealthDay News) — Uterine balloon tamponade (UBT) has a high success rate for stopping bleeding among women with severe postpartum hemorrhage (PPH) unresponsive to uterotonics, according to a review published online Jan. 6 in the American Journal of Obstetrics & Gynecology.
Sebastian Suarez, M.D., from Massachusetts General Hospital in Boston, and colleagues conducted a systematic literature search to identify studies that reported on the efficacy, effectiveness, and/or safety of UBT in women with PPH.
Based on 91 studies (4,729 women), the researchers found that the overall pooled UBT success rate was 85.9 percent (95 percent confidence interval, 83.9 to 87.9). The highest success rates were seen with uterine atony (87.1 percent) and placenta previa (86.8 percent), while the lowest success rate was seen with placenta accreta spectrum (66.7 percent) and retained products of conception (76.8 percent). Success rates were lower in cesarean deliveries (81.7 percent) versus vaginal deliveries (87.0 percent). Based on a meta-analysis of two randomized trials, the investigators observed no significant differences in the risk for surgical interventions or maternal death (relative risk, 0.59; 95 percent confidence interval, 0.02 to 16.69) between UBT and no UBT in PPH due to uterine atony after vaginal delivery. Based on a meta-analysis of two nonrandomized before-and-after studies, the researchers found that introduction of UBT in protocols for managing severe PPH significantly decreased the use of arterial embolization (relative risk, 0.29; 95 percent confidence interval, 0.14 to 0.63). The overall frequency of complications due to UBT use was low (≤6.5 percent).
“UBT has a high success rate for treating severe PPH and appears to be safe. The evidence on UBT efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect in contrast with observational studies,” the authors write. “Further research is needed to determine the most effective programmatic and health care delivery strategies on UBT introduction and use.”
One author disclosed ties to the Ujenzi Charitable Trust, which received U.S. Food and Drug Administration approval for the “Every Second Matters-Uterine Balloon Tamponade” device.
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