Impact of the introduction of a low-cost uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage in India: A comparative before-and-after study.

Abstract

To evaluate the impact of introducing a uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH-related maternal death and invasive procedures for PPH control. We used a quasi-experimental, difference-in-difference (DID) design to compare changes in the rates of a composite outcome (PPH-related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM-UBT. The study sample included 214 123 deliveries (n=78 509 before ESM-UBT introduction; n=47 211 during ESM-UBT introduction; and n=88 403 after ESM-UBT introduction). After introduction of ESM-UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0-11.4 per 10000 deliveries; difference -9.6, 95% confidence interval -14.0 to -5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7-17.2 per 10000 deliveries; difference 5.4, 95% confidence interval -3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate -15.0 per 10000 points, 95% confidence interval -23.3 to -6.8; P=0.005). Introduction of the ESM-UBT in health facilities in India was associated with a significant reduction in PPH-related maternal death and/or invasive procedures for PPH control.