Quality of care for postpartum hemorrhage: A direct observation study in referral hospitals in Kenya.

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in Kenya. The aim of this study was to measure quality and timeliness of care for PPH in a sample of deliveries in referral hospitals in Kenya. We conducted direct observations of 907 vaginal deliveries in three Kenyan hospitals from October 2018 through February 2019, observing the care women received from admission for labor and delivery through hospital discharge. We identified cases of "suspected PPH", defined as cases in which providers indicated suspicion of and/or took an action to manage abnormal bleeding. We measured adherence to World Health Organization and Kenyan guidelines for PPH risk assessment, prevention, identification, and management and the timeliness of care in each domain. The rate of suspected PPH among the observed vaginal deliveries was 9% (95% Confidence Interval: 7% - 11%). Health care providers followed all guidelines for PPH risk assessment in 7% (5% - 10%) of observed deliveries and all guidelines for PPH prevention in 4% (3% - 6%) of observed deliveries. Lowest adherence was observed for taking vital signs and for timely administration of a prophylactic uterotonic. Providers did not follow guidelines for postpartum monitoring in any of the observed deliveries. When suspected PPH occurred, providers performed all recommended actions in 23% (6% - 40%) of cases. Many of the critical actions for suspected PPH were performed in a timely manner, but, in some cases, substantial delays were observed. In conclusion, we found significant gaps in the quality of risk assessment, prevention, identification, and management of PPH after vaginal deliveries in referral hospitals in Kenya. Efforts to reduce maternal morbidity and mortality from PPH should emphasize improvements in the quality of care, with a particular focus on postpartum monitoring and timely emergency response.

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.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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 10 000 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 10 000 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 10 000 points, 95% confidence interval -23.3 to -6.8; P = 0.005). CONCLUSION: 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.

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

OBJECTIVE: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH). METHODS: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting. RESULTS: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. CONCLUSION: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

Feasibility of a Ketamine Anesthesia Package in Support of Obstetric and Gynecologic Procedures in Kenya When No Anesthetist is Available.

The objective was to assess the feasibility and safety of the ̳Every Second Matters for Emergency and Essential Surgery - Ketamine' (ESM-Ketamine) package in support of obstetric and gynecologic emergency and essential surgery when no anesthetist is available. A consecutive case series was conducted in twelve hospitals across five severely resource-limited counties in Kenya. 530 women underwent obstetric or gynecological operative procedures supported by non-anesthetist clinicians using the ESM-Ketamine package between November 1, 2013 and September 30, 2017. Main outcomes included reasons for ESM-Ketamine activations and ketamine-related adverse events. There were two (0.4%) prolonged (>30 seconds) oxygen desaturations below 92%. Brief oxygen desaturations (<30 seconds) below 92% occurred in 15 (2.8%) cases and 113 (21.3%) were administered diazepam to treat hallucinations or agitation. There were no ketamine-related deaths or injuries. The ESM- Ketamine package appears feasible and safe for use in support of obstetric and gynecologic surgeries when no anesthetist is available.

Feasibility of a ketamine anesthesia package in support of obstetric and gynecologic procedures in Kenya when no anesthetist is available

The objective was to assess the feasibility and safety of the _Every Second Matters for Emergency and Essential Surgery ­ Ketamine' (ESM-Ketamine) package in support of obstetric and gynecologic emergency and essential surgery when no anesthetist is available. A consecutive case series was conducted in twelve hospitals across five severely resource-limited counties in Kenya. 530 women underwent obstetric or gynecological operative procedures supported by non-anesthetist clinicians using the ESM-Ketamine package between November 1, 2013 and September 30, 2017. Main outcomes included reasons for ESM-Ketamine activations and ketamine-related adverse events. There were two (0.4%) prolonged (>30 seconds) oxygen desaturations below 92%. Brief oxygen desaturations (<30 seconds) below 92% occurred in 15 (2.8%) cases and 113 (21.3%) were administered diazepam to treat hallucinations or agitation. There were no ketamine-related deaths or injuries. The ESM-Ketamine package appears feasible and safe for use in support of obstetric and gynecologic surgeries when no anesthetist is available

Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

BACKGROUND: Postpartum 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. METHODS: Data 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. RESULTS: Of 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. CONCLUSION: The ESM-UBT device appears safe for use in women with uncontrolled PPH. TRIAL REGISTRATION: Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

Correction to: Safety and Feasibility of a Ketamine Package to Support Emergency and Essential Surgery in Kenya when No Anesthetist is Available: An Analysis of 1216 Consecutive Operative Procedures.

The corrected order of the authors is as reflected in this erratum. Sebastian Suarez and Ayla Senay are co-second authors.

Safety and Feasibility of a Ketamine Package to Support Emergency and Essential Surgery in Kenya when No Anesthetist is Available: An Analysis of 1216 Consecutive Operative Procedures.

BACKGROUND: Lack of access to emergency and essential surgery is widespread in low- and middle-income countries. Scarce anesthesia services contribute to this unmet need. The aim of this study was to evaluate the safety and feasibility of the Every Second Matters for Emergency and Essential Surgery-Ketamine (ESM-Ketamine) package for emergency and essential procedures when no anesthetist was available. METHODS: From November 2013 to September 2017, the ESM-Ketamine package was used for patients requiring emergency or life-improving surgeries in fifteen selected facilities across Kenya when no anesthetist was available. A mixed-methods approach was used to assess safety and feasibility of the ESM-Ketamine package, including demand, acceptability, and practicality. The primary outcome was ketamine-related adverse events. Key-informant interviews captured perceptions of providers, hospital administrators, and surgeons/proceduralists. RESULTS: Non-anesthetist mid-level providers used ESM-Ketamine for 1216 surgical procedures across the fifteen study facilities. The median ketamine dose was 2.1 mg/kg. Brief (<30 s) oxygen desaturations occurred in 39 patients (3%), and prolonged (>30 s) oxygen desaturations occurred in seven patients (0.6%). There were 157 (13%) reported cases of hallucinations and agitation which were treated with diazepam. All patients recovered uneventfully, and no ketamine-related deaths were reported. Twenty-seven key-informant interviews showed strong support for the program with four main themes: financial considerations, provision of services, staff impact, and scaling considerations. CONCLUSIONS: The ESM-Ketamine package appears safe and feasible and is capable of expanding access to emergency and essential surgeries in rural Kenya when no anesthetist is available.

Shock progression and survival after use of a condom uterine balloon tamponade package in women with uncontrolled postpartum hemorrhage.

OBJECTIVE: To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. METHODS: In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. RESULTS: Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). CONCLUSION: The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony.

Evaluation of a ketamine-based anesthesia package for use in emergency cesarean delivery or emergency laparotomy when no anesthetist is available.

OBJECTIVE: To assess the safety of a ketamine-based rescue anesthesia package to support emergency cesarean delivery and emergency laparotomy when no anesthetist was available. METHODS: A prospective case-series study was conducted at seven sub-county hospitals in western Kenya between December 10, 2013, and January 20, 2016. Non-anesthetist clinicians underwent 5days of training in the Every Second Matters-Ketamine (ESM-Ketamine) program. A database captured preoperative, intraoperative, and postoperative details of all surgeries in which ESM-Ketamine was used. The primary outcome measure was the ability of ESM-Ketamine to safely support emergency operative procedures. RESULTS: Non-anesthetist providers trained on ESM-Ketamine supported 83 emergency cesarean deliveries and 26 emergency laparotomies. Ketamine was administered by 10 nurse-midwives and six clinical officers. Brief oxygen desaturations (<92% for <30s) were recorded among 5 (4.6%) of the 109 patients. Hallucinations occurred among 9 (8.3%) patients. No serious adverse events related to the use of ESM-Ketamine were recorded. CONCLUSION: The ESM-Ketamine package can be safely used by trained non-anesthetist providers to support emergency cesarean delivery and emergency laparotomy when no anesthetist is available.

Emergency department quality and safety indicators in resource-limited settings: an environmental survey.

BACKGROUND: As global emergency care grows, practical and effective performance measures are needed to ensure high quality care. Our objective was to systematically catalog and classify metrics that have been used to measure the quality of emergency care in resource-limited settings. METHODS: We searched MEDLINE, Embase, CINAHL, and the gray literature using standardized terms. The references of included articles were also reviewed. Two researchers screened titles and abstracts for relevance; full text was then reviewed by three researchers. A structured data extraction tool was used to identify and classify metrics into one of six Institute of Medicine (IOM) quality domains (safe, timely, efficient, effective, equitable, patient-centered) and one of three of Donabedian's structure/process/outcome categories. A fourth expert reviewer blinded to the initial classifications re-classified all indicators, with a weighted kappa of 0.89. RESULTS: A total of 1705 articles were screened, 95 received full text review, and 34 met inclusion criteria. One hundred eighty unique metrics were identified, predominantly process (57 %) and structure measures (27 %); 16 % of metrics were related to outcomes. Most metrics evaluated the effectiveness (52 %) and timeliness (28 %) of care, with few addressing the patient centeredness (11 %), safety (4 %), resource-efficiency (3 %), or equitability (1 %) of care. CONCLUSIONS: The published quality metrics in emergency care in resource-limited settings primarily focus on the effectiveness and timeliness of care. As global emergency care is built and strengthened, outcome-based measures and those focused on the safety, efficiency, and equitability of care need to be developed and studied to improve quality of care and resource utilization.