Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage. STUDY DESIGN: We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. RESULTS: Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9-87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02-16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14-0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage-related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%). CONCLUSION: Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use.

A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.

Patient Characteristics from an Emergency Care Center in Rural Western Kenya.

BACKGROUND: Emergency care is a neglected area of focus in many low- and middle-income countries. There is a paucity of research on types and frequencies of acute illnesses and injuries in low-resource settings. OBJECTIVE: The primary objective of this study was to describe the demographic characteristics and emergency conditions of patients that presented to a new emergency care center (ECC) at Sagam Community Hospital in Luanda, Kenya. METHODS: Patient demographic characteristics, modes of arrival, chief symptoms, triage priorities, self-reported human immunodeficiency virus status, tests performed, interventions, discharge diagnoses, and dispositions were collected for all patients that presented to the Sagam Community Hospital ECC. RESULTS: Between October 1, 2016 and September 30, 2017, 14,518 patients presented to the ECC. The most common mode of arrival to Sagam Community Hospital was by foot (n = 12,605 [86.8%]). There were 8931 (61.5%) female patients and 5571 (38.4%) male patients. Of the total visits, 12,668 (87.3%) were triaged Priority III (lowest priority), 1239 (8.5%) were Priority II, and 293 (2.0%) were Priority I (highest priority). The most common chief symptoms were headache (n = 3923 [15.2%]), hotness of body or chills (n = 2877 [8.8%]), and cough (n = 1827 [5.5%]). The three most common discharge diagnoses were malaria (n = 3692 [18.9%]), acute upper respiratory infection (n = 1242 [6.3%]), and gastritis/duodenitis (n = 1210 [6.2%]). CONCLUSIONS: Although opening an ECC in rural Kenya attracted patients in need of care, access was limited primarily to those that could arrive on foot. ECCs in rural sub-Saharan Africa have the potential to provide quality care and support attainment of Sustainable Development Goals.

Hyaluronidase-Assisted Resuscitation in Kenya for Severely Dehydrated Children.

BACKGROUND: Dehydration, mainly due to diarrheal illnesses, is a leading cause of childhood mortality worldwide. Intravenous (IV) therapy is the standard of care for patients who were unable to tolerate oral rehydration; however, placing IVs in fragile, dehydrated veins can be challenging. Studies in resource-rich settings comparing hyaluronidase-assisted subcutaneous rehydration with standard IV rehydration in children have demonstrated several benefits of subcutaneous rehydration, including time and success of line placement, ease of use, satisfaction, and cost-effectiveness. METHODS: A single-arm trial assessing the feasibility of hyaluronidase-assisted subcutaneous resuscitation for the treatment of moderately to severely dehydrated individuals in western Kenya was conducted. Children aged 2 months or older who presented with moderately to severely dehydration clinically warranting parenteral rehydration and had at least 2 failed IV attempts were eligible. Study staff received training on standard dehydration management and hyaluronidase infusion processes. Children received all other standards of care. They were monitored from presentation and through discharge, with a 1-week phone follow-up. Predischarge surveys were completed by caregivers, and semistructured interviews with providers were performed. RESULTS: A total of 51 children were enrolled (median age, 13.0 months; interquartile range of 18 months). Fifty-one patients (100%) had severe dehydration. The median length of subcutaneous infusion was 3.0 hours (interquartile range [IQR], 2.95). The median total subcutaneous infusion was 700.0 mL (IQR, 420 mL). Median time to resolution of moderate to severe dehydration symptoms was 3.0 hours (IQR, 2.95 hours). There were no significant complications. CONCLUSIONS: Hyaluronidase-assisted subcutaneous resuscitation is a feasible alternative to IV hydration in moderately to severely dehydrated children with difficult to obtain IV access in resource-limited areas.

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.

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.

A low-cost uterine balloon tamponade for management of postpartum hemorrhage: modeling the potential impact on maternal mortality and morbidity in sub-Saharan Africa.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide. This study sought to quantify the potential health impact (morbidity and mortality reductions) that a low-cost uterine balloon tamponade (UBT) could have on women suffering from uncontrolled PPH due to uterine atony in sub-Saharan Africa. METHODS: The Maternal and Neonatal Directed Assessment of Technology (MANDATE) model was used to estimate maternal deaths, surgeries averted, and cases of severe anemia prevented through UBT use among women with PPH who receive a uterotonic drug but fail this therapy in a health facility. Estimates were generated for the year 2018. The main outcome measures were lives saved, surgeries averted, and severe anemia prevented. RESULTS: The base case model estimated that widespread use of a low-cost UBT in clinics and hospitals could save 6547 lives (an 11% reduction in maternal deaths), avert 10,823 surgeries, and prevent 634 severe anemia cases in sub-Saharan Africa annually. CONCLUSIONS: A low-cost UBT has a strong potential to save lives and reduce morbidity. It can also potentially reduce costly downstream interventions for women who give birth in a health care facility. This technology may be especially useful for meeting global targets for reducing maternal mortality as identified in Sustainable Development Goal 3.

Nurse-midwives' ability to diagnose acute third- and fourth-degree obstetric lacerations in western Kenya.

BACKGROUND: Obstetric fistula devastates the lives of women and is found most commonly among the poor in resource-limited settings. Unrepaired third- and fourth-degree perineal lacerations have been shown to be the source of approximately one-third of the fistula burden in fistula camps in Kenya. In this study, we assessed potential barriers to accurate identification by Kenyan nurse-midwives of these complex perineal lacerations in postpartum women. METHODS: Nurse-midwife trainers from each of the seven sub-counties of Siaya County, Kenya were assessed in their ability to accurately identify obstetric lacerations and anatomical structures of the perineum, using a pictorial assessment tool. Referral pathways, follow-up mechanisms, and barriers to assessing obstetric lacerations were evaluated. RESULTS: Twenty-two nurse-midwife trainers were assessed. Four of the 22 (18.2%) reported ever receiving formal training on evaluating third- and fourth-degree obstetric lacerations, and 20 of 22 (91%) reported health-system challenges to adequately completing their examination of the perineum at delivery. Twenty-one percent of third- and fourth-degree obstetric lacerations in the pictorial assessment were incorrectly identified as first- or second-degree lacerations. CONCLUSION: County nurse-midwife trainers in Siaya, Kenya, experience inadequate training, equipment, staffing, time, and knowledge as barriers to adequate diagnosis and repair of third- and fourth-degree perineal tears.

Prevalence of unrepaired third- and fourth-degree tears among women taken to the operating room for repair of presumed obstetric fistula during two fistula camps in Kenya.

INTRODUCTION AND HYPOTHESIS: More than 2 million women on earth today are said to be suffering from obstetric fistula (OF), a communication between the vagina and either the urinary tract or rectum. Since unrepaired third- and fourth-degree perineal tears often manifest with symptoms identical to OF, we hypothesized that the global burden of OF is in part due to these unrepaired deep obstetric tears. METHODS: Four consultant gynecologists retrospectively reviewed the medical and operative records of all obstetric fistula cases that underwent surgical repair during the July and August, 2014, Kenyatta National Hospital and Embu Provincial Hospital Fistula Camps in Kenya. RESULTS: One hundred and eighty charts were reviewed. All 180 women had fecal incontinence (FI), urinary incontinence (UI), or both as their primary complaint. Sixty of the 180 (33 %) women had isolated FI as their presenting symptom, and at operation, 57 of these 60 (95 %) were found to have unrepaired third- and fourth-degree obstetric tears. Ninety-two of the 180 (51 %) women with OF symptoms ultimately had true OF confirmed at operation. CONCLUSION: These findings suggest that many women with OF symptoms in Kenya may harbor unrepaired third- and fourth-degree tears. Additionally, women with isolated FI may be more likely to suffer from third- and fourth-degree tears than from true OF. Immediate postpartum diagnosis and repair of third- and fourth-degree perineal tears could significantly reduce the overall burden of women with symptoms of OF.

Use of prophylactic uterotonics during the third stage of labor: a survey of provider practices in community health facilities in Sierra Leone.

BACKGROUND: Postpartum hemorrhage remains the leading cause of maternal mortality worldwide. Administration of uterotonics during the third stage of labor is a simple and well established intervention that can significantly decrease the development of postpartum hemorrhage. Little is known about the use of prophylactic uterotonics in peripheral health centers, where the majority of normal deliveries occur. The purpose of this study is to assess health provider current practices and determinants to the use of prophylactic uterotonics in Sierra Leone, a country with one of the highest maternal mortality ratios worldwide. METHODS: This is a mixed methods study using descriptive cross-sectional survey and qualitative interviews in community health facilities in Freetown, Sierra Leone following a comprehensive training on postpartum hemorrhage. Facilities and providers were surveyed between May and June 2014. Qualitative methods were used to identify barriers and facilitators to the use of prophylactic uterotonics. RESULTS: A total of 134 providers were surveyed at 39 periphreal health facilities. Thirteen facilities (39 %) reported an inconsistent supply of oxytocin. The majority of facilities (64 %) stored oxytocin at room temperature. Provider level, in-service training, and leadership role were significantly associated with prophylactic uterotonic use. Overall, 62 % of providers reported routine use. Midwives were most likely to routinely administer uterotonics (93 %), followed by community health officers/assistants (78 %), maternal and child health aides (56 %), and state-enrolled community health nurses (52 %). Of the providers who received in-service training, 67 % reported routine use; of those with no in-service training, 42 % reported routine use. Qualitative analysis revealed that facility protocols, widespread availability, and provider perception of utility facilitated routine use. Common barriers reported included inconsistent supply of uterotonics, lack of knowledge regarding timely administration, and provider attitude regarding utility of uterotonics following normal deliveries. CONCLUSION: There is considerable room for improvement in availability and administration of prophylactic uterotonics. Understanding barriers to routine use may aid in developing multifaceted pre-service and in-service training interventions designed to improve routine intrapartum care.

Emergency care and referral among isolated island populations in the Bahamas.

BACKGROUND: Isolated island populations face unique health challenges. In the Bahamas, the islands of Mayaguana, Inagua, Crooked Island, Acklins, and Long Cay-referred to as the MICAL Constituency-are among the most isolated. OBJECTIVES: Our objective was to better understand regional emergency care needs and capabilities, and determine how emergency care can be optimized among island populations. METHODS: During the summer of 2013, the project team conducted semi-structured key-informant interviews and small-group discussions among all health care teams in the MICAL region, as well as a community-based household survey on the island of Mayaguana. The interviews and small-group discussions consisted of open-response questions related to health care services, equipment, supplies, medications, and human resources. The community-based survey examined the prevalence of chronic noncommunicable diseases (CNCDs) and associated risk factors affecting the inhabitants of the region. RESULTS: The average number of annual emergency referrals from each of the MICAL islands was approximately 25-30, and reasons for referrals off-island included chest pain, abdominal pain, trauma, and dysfunctional uterine bleeding. Traditional prehospital care is not established in the MICAL Constituency. Providers reported feelings of isolation from the distant health system in Nassau. Whereas most clinics have a well-stocked pharmacy of oral medications, diagnostic capabilities are limited. The household survey showed a high prevalence of CNCDs and associated risk factors. CONCLUSION: Ongoing in-service emergency care training among MICAL providers is needed. Additional equipment could significantly improve emergency care capabilities, specifically, equipment to manage chest pain, fractures, and other trauma. Community-based preventive services and education could improve the overall health of the island populations.

Innovating for the developing world: meeting the affordability challenge.

OBJECTIVE: Ultrasound technologies have gained increasing prominence and accessibility in the developing world as manufacturers focus on this region as an emerging market. More extensive ultrasound use holds promise for addressing the disproportionate morbidity and mortality that continues to plague the developing world, particularly in the area of obstetrics. CONCLUSION: In this article, we describe the challenge of making ultrasound technologies affordable to health care providers in resource-limited regions vis-à-vis an innovative group of midwives in Nairobi.

An international comparative public health analysis of sex trafficking of women and girls in eight cities: achieving a more effective health sector response.

Sex trafficking, trafficking for the purpose of forced sexual exploitation, is a widespread form of human trafficking that occurs in all regions of the world, affects mostly women and girls, and has far-reaching health implications. Studies suggest that up to 50 % of sex trafficking victims in the USA seek medical attention while in their trafficking situation, yet it is unclear how the healthcare system responds to the needs of victims of sex trafficking. To understand the intersection of sex trafficking and public health, we performed in-depth qualitative interviews among 277 antitrafficking stakeholders across eight metropolitan areas in five countries to examine the local context of sex trafficking. We sought to gain a new perspective on this form of gender-based violence from those who have a unique vantage point and intimate knowledge of push-and-pull factors, victim health needs, current available resources and practices in the health system, and barriers to care. Through comparative analysis across these contexts, we found that multiple sociocultural and economic factors facilitate sex trafficking, including child sexual abuse, the objectification of women and girls, and lack of income. Although there are numerous physical and psychological health problems associated with sex trafficking, health services for victims are patchy and poorly coordinated, particularly in the realm of mental health. Various factors function as barriers to a greater health response, including low awareness of sex trafficking and attitudinal biases among health workers. A more comprehensive and coordinated health system response to sex trafficking may help alleviate its devastating effects on vulnerable women and girls. There are numerous opportunities for local health systems to engage in antitrafficking efforts while partnering across sectors with relevant stakeholders.

Feasibility and impact of a postpartum hemorrhage emergency care package using a bundle approach in Migori County, Kenya.

OBJECTIVE: To investigate the impact of the PPH Emergency Care package (PPH EmC)-a holistic intervention that uses a bundle approach that has been implemented in Kenya, India, Nepal, Bangladesh, and Central America-in a low-resource setting. METHODS: The feasibility and impact of PPH EmC implementation in Migori County, Kenya was studied using a qualitative research design. In March and April 2022 key informants were identified using purposive sampling. Semi-structured interviews were conducted over Zoom from March to May 2022 until thematic saturation was reached. Interviews were transcribed, coded, and analyzed for emerging themes. RESULTS: PPH EmC has positively impacted facility and health system preparedness, referral coordination, teamwork and communication, and overall capacity to provide quality PPH emergency care. Participants reported that PPH EmC is sustainable because of its low cost and support from local partners. CONCLUSION: Implementation of PPH EmC in Migori County, Kenya was feasible and positively impacted PPH emergency care.

Effectiveness of a novel bubble CPAP system for neonatal respiratory support at a referral hospital in the Philippines.

Aim: To examine the impact of introducing and implementing the Vayu bubble continuous positive airway pressure (bCPAP) system on neonatal survival and neonatal respiratory outcomes in a neonatal intensive care unit (NICU) in the Philippines. Methods: We compared clinical outcomes of 1,024 neonates before to 979 neonates after introduction of Vayu bCPAP systems into a NICU. The primary outcome was survival to discharge. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated. Analyses were undertaken separately for the entire NICU population and for neonates who received any form of respiratory support. Results: The introduction of the Vayu bCPAP system was associated with (1) significant reductions in intubation (aOR: 0.75; 95% CI: 0.58-0.96) and in the use of nasal intermittent positive-pressure ventilation (NIPPV) (aOR: 0.69; 95% CI: 0.50-0.96) among the entire NICU population and (2) a significant increase in survival to discharge (aOR: 1.53; 95% CI: 1.09-2.17) and significant reductions in intubation (aOR: 0.52; 95% CI: 0.38-0.71), surfactant administration (aOR: 0.60; 95% CI: 0.40-0.89), NIPPV use (aOR: 0.52; 95% CI: 0.36-0.76), and a composite neonatal adverse outcome (aOR: 0.60; 95% CI: 0.42-0.84) among neonates who received any form of respiratory support. Conclusion: The use of the Vayu bCPAP system in a NICU in the Philippines resulted in significant improvement in neonatal respiratory outcomes.