Abstract
BackgroundPostpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone.MethodsData were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis.ResultsOf the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely.ConclusionThe ESM-UBT device appears safe for use in women with uncontrolled PPH.Trial registrationTrial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
Highlights
Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries
The data collection cards documented the kit tracking number, facility name, delivery date and time, interventions performed prior to uterine balloon tamponade (UBT) placement, mental status and vital signs at the time of UBT placement, effectiveness of hemorrhage control, steps taken after UBT placement, need for maternal resuscitation or transfusion, and adverse events
Three expert maternal health investigator physicians (AR, ME, and TB) analyzed each complication/adverse event and deliberated on whether there was a potential causal relationship associated with use of the ESM-UBT device
Summary
Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. Reduction of maternal mortality has been a worldwide focus since 1990, a recent World Health Organization report on progress from 1990 to 2015 described that PPH-associated mortality remains unacceptably high, with 54,000 deaths in sub-Saharan Africa in 2015 alone [1, 2]. The majority of these deaths could have been averted with timely access to quality emergency obstetric care [2, 3]. UBT devices were unavailable in these regions [2,3,4]
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