Postpartum infection, pain and experiences with care among women treated for postpartum hemorrhage in three African countries: A cohort study of women managed with and without condom-catheter uterine balloon tamponade.

OBJECTIVE: We aimed to determine the risk of postpartum infection and increased pain associated with use of condom-catheter uterine balloon tamponade (UBT) among women diagnosed with postpartum hemorrhage (PPH) in three low- and middle-income countries (LMICs). We also sought women's opinions on their overall experience of PPH care. METHODS: This prospective cohort study compared women diagnosed with PPH who received and did not receive UBT (UBT group and no-UBT group, respectively) at 18 secondary level hospitals in Uganda, Egypt, and Senegal that participated in a stepped wedge, cluster-randomized trial assessing UBT introduction. Key outcomes were reported pain (on a scale 0-10) in the immediate postpartum period and receipt of antibiotics within four weeks postpartum (a proxy for postpartum infection). Outcomes related to satisfaction with care and aspects women liked most and least about PPH care were also reported. RESULTS: Among women diagnosed with PPH, 58 were in the UBT group and 2188 in the no-UBT group. Self-reported, post-discharge antibiotic use within four weeks postpartum was similar in the UBT (3/58, 5.6%) and no-UBT groups (100/2188, 4.6%, risk ratio = 1.22, 95% confidence interval [CI]: 0.45-3.35). A high postpartum pain score of 8-10 was more common among women in the UBT group (17/46, 37.0%) than in the no-UBT group (360/1805, 19.9%, relative risk ratio = 3.64, 95% CI:1.30-10.16). Most women were satisfied with their care (1935/2325, 83.2%). When asked what they liked least about care, the most common responses were that medications (580/1511, 38.4%) and medical supplies (503/1511, 33.3%) were unavailable. CONCLUSION: UBT did not increase the risk of postpartum infection among this population. Women who receive UBT may experience higher degrees of pain compared to women who do not receive UBT. Women's satisfaction with their care and stockouts of medications and other supplies deserve greater attention when introducing new technologies like UBT.

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.

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.

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.

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.

A Public Health Priority: Disparities in Gynecologic Cancer Research for African-Born Women in the United States.

African-born immigrants comprise one of the fastest growing populations in the U.S., nearly doubling its population size in recent years. However, it is also one of the most underrepresented groups in health-care research, especially research focused on gynecologic and breast malignancies. While the opportunity exists for access to an advanced health-care system, as immigrants migrate to the U.S., they encounter the same health-care inequalities that are faced by the native-born population based on ethnicity and social class, potentiated by limitations of health literacy and lack of familiarity with U.S. health systems. Given the continued influx of African-born immigrants in the U.S., we sought to understand the representation of this population in cervical and breast cancer research, recognizing the population's high risk for these diseases at baseline while residing in their native countries. We determined that there is limited research in these diseases that disproportionately affect them; yet, there are identifiable and potentially modifiable factors that contribute to this paucity of evidence. This clinical commentary seeks to underscore the clear lack of research available involving African-born immigrants with respect to gynecologic and breast malignancies in the existing literature, demonstrate the need for more robust research in this population, and provide fundamental insights into barriers and solutions critical to the continued health of this growing population.

Provider experiences with improvised uterine balloon tamponade for the management of uncontrolled postpartum hemorrhage in Kenya.

OBJECTIVE: To understand healthcare providers' experiences with improvised uterine balloon tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH). METHODS: In a qualitative descriptive study, in-depth semi-structured interviews were conducted between November 2014 and June 2015 among Kenyan healthcare providers who had previous experience with improvising a UBT device. Interviews were conducted, audio-recorded, and transcribed. RESULTS: Overall, 29 healthcare providers (14 nurse-midwifes, 7 medical officers, 7 obstetricians, and 1 clinical officer) were interviewed. Providers perceived improvised UBT as valuable for managing uncontrolled PPH. Reported benefits included effectiveness in arresting hemorrhage and averting hysterectomy, and ease of use by providers of all levels of training. Providers used various materials to construct an improvised UBT. Challenges to improvising UBT-e.g. searching for materials during an emergency, procuring male condoms, and inserting fluid via a small syringe-were reported to lead to delays in care. Providers described their introduction to improvised UBT through both formal and informal sources. There was universal enthusiasm for widespread standardized training. CONCLUSION: Improvised UBT seems to be a valuable second-line treatment for uncontrolled PPH that can be used by providers of all levels. UBT might be optimized by integrating a standard package across the health system.

Provider experience of uterine balloon tamponade for the management of postpartum hemorrhage in Sierra Leone.

OBJECTIVE: To understand healthcare providers' experience of incorporating uterine balloon tamponade (UBT) into the national postpartum hemorrhage (PPH) clinical pathway after UBT training. METHODS: In a qualitative study, semi-structured interviews were undertaken with healthcare providers from 50 centers in Freetown, Sierra Leone, between May and June 2014. All eligible healthcare providers (undergone UBT training, actively conducted deliveries, and treated cases of PPH since UBT training) on duty at the time of center visit were interviewed. RESULTS: Sixty-one providers at 47 facilities were interviewed. Bleeding was controlled in 28 (93%) of 30 cases of UBT device placement. Participants reported that UBT devices were easy to insert with only minor challenges, and enabled providers to manage most cases of uncontrolled PPH at their own facility and to refer others in a stable condition. Reported barriers to optimal UBT use included insufficient training and practical experience, and a scarcity of preassembled UBT devices. Facilitators of UBT use included widespread acceptance of UBT, comprehensive and enthusiastic training, and ready availability of UBT devices. CONCLUSION: UBT-used either as a primary endpoint or en route to obtaining advanced care-has been well accepted and integrated into the national PPH pathway by providers in health facilities in Freetown.

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.

A qualitative assessment of the impact of a uterine balloon tamponade package on decisions regarding the role of emergency hysterectomy in women with uncontrolled postpartum haemorrhage in Kenya and Senegal.

OBJECTIVES: To assess the impact of a every second matters for mothers and babies uterine balloon tamponade package (ESM-UBT) on provider decisions regarding emergency hysterectomy in cases of uncontrolled postpartum haemorrhage (PPH). DESIGN: Qualitative assessment and analysis of a subgroup extracted from a larger database that contains all UBT device uses among ESM-UBT trained health providers. SETTING: Health facilities in Kenya and Senegal with ESM-UBT training and capable of performing emergency hysterectomies. PARTICIPANTS: All medical doctors who had placed a UBT for uncontrolled PPH subsequent to implementation of ESM-UBT at their facility, and who also had the capabilities of performing emergency hysterectomies. PRIMARY OUTCOME MEASURES: The impact of ESM-UBT on decisions regarding emergency hysterectomy in cases of uncontrolled PPH. RESULTS: 30 of the 31 medical doctors (97%) who fulfilled the inclusion criteria were independently interviewed. Collectively the interviewed medical doctors had placed over 80 UBT devices for uncontrolled PPH since ESM-UBT implementation. All 30 responded that UBT devices immediately controlled haemorrhage and prevented women from being taken to emergency hysterectomy. All 30 would continue to use UBT devices in future cases of uncontrolled PPH. CONCLUSIONS: These preliminary data suggest that following ESM-UBT implementation, emergency hysterectomy for uncontrolled PPH may be averted by use of uterine balloon tamponade.

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.

Provider experiences with uterine balloon tamponade for uncontrolled postpartum hemorrhage in health facilities in Kenya.

OBJECTIVE: To understand provider perceptions and experiences following training in the use of a condom-catheter uterine balloon tamponade (UBT) as second-line treatment for uncontrolled postpartum hemorrhage (PPH) in health facilities in Kenya. METHODS: As part of a qualitative study, interviews of facility-based providers who had managed PPH following comprehensive PPH training were conducted between February and April 2014. Facilities were purposively sampled to represent a range of experience with UBT, facility size, and geography. Interviews continued until thematic saturation was achieved. Interview transcripts were analyzed for themes. RESULTS: Overall, 68 providers from 29 facilities were interviewed, of whom 31 reported experience with UBT placement (25 midwives, 2 clinical officers, 4 medical officers). Qualitative analysis revealed several major themes. Providers used UBT appropriately within the PPH algorithm, although the timing and clinical severity of patients varied. UBT was most commonly used when bleeding was unresponsive to uterotonics, hysterectomy was unavailable, and referral times long. Providers reported that bleeding was arrested following UBT use in all except one patient, who had a suspected coagulopathy. Most providers described UBT as technically easy to use, although three described initial balloon displacement. CONCLUSION: UBT has been readily accepted by providers at all levels of training and is being incorporated into the existing PPH management algorithm in Kenya.

More than interpreters needed: the specialized care of the immigrant pregnant patient.

The immigrant pregnant woman faces unique challenges. This article provides an overview of these challenges and interventions to maximize health outcomes for the immigrant pregnant woman. A patient's immigrant status may impact her social stability and access to health care. Lack of familiarity with western health care, health financing, and the English language can create significant barriers. In addition, providers must remember to evaluate the immigrant pregnant woman for underlying health conditions that may be present including infectious diseases endemic to their country of origin and chronic diseases or cervical center as yet unidentified because of lack of previous health care screening. Female genital modification found in some immigrant populations can be associated with poorer obstetric outcomes and should be documented and addressed. Finally, some immigrant populations have a high incidence of past severe trauma and need additional psychiatric evaluation and support.

Use of uterine balloon tamponade for control of postpartum hemorrhage by community-based health providers in South Sudan.

OBJECTIVE: To determine whether use of uterine balloon tamponade (UBT) for management of uncontrolled postpartum hemorrhage (PPH) by community-based providers in a resource-limited setting could be feasible, effective, and safe. METHODS: In rural South Sudan, community providers were trained and equipped with a simple UBT device consisting of a catheter, condom, and syringe. Snowball sampling identified cases of UBT use since training. Semi-structured interviews were conducted among community providers, referral facility providers, patients, and patient family members. Interview transcripts were analyzed using qualitative methods. RESULTS: Thirteen cases were identified and 24 interviews related to community-based UBT use were conducted. Qualitative analysis revealed several major themes. Community providers applied UBT in appropriate clinical situations. UBT was effective for controlling PPH, even among severely ill patients. Referral was difficult and lengthy owing to the austere setting, but simple UBT appeared to mitigate these challenges. Communities had some initial fears, yet ultimately embraced UBT. Equipment and supplies were largely maintained. There was universal satisfaction with UBT among patients, family members, and providers. One death occurred among the 13 cases, although it was probably not attributable to PPH. CONCLUSION: Training and UBT device provision are simple, affordable, and effective for managing uncontrolled PPH in a resource-limited setting.

Human trafficking: review of educational resources for health professionals.

CONTEXT: Human trafficking is an increasingly well-recognized human rights violation that is estimated to involve more than 2 million victims worldwide each year. The health consequences of this issue bring victims into contact with health systems and healthcare providers, thus providing the potential for identification and intervention. A robust healthcare response, however, requires a healthcare workforce that is aware of the health impact of this issue; educated about how to identify and treat affected individuals in a compassionate, culturally aware, and trauma-informed manner; and trained about how to collaborate efficiently with law enforcement, case management, and advocacy partners. This article describes existing educational offerings about human trafficking designed for a healthcare audience and makes recommendations for further curriculum development. EVIDENCE ACQUISITION: A keyword search and structured analysis of peer-reviewed and gray literature, conducted in 2011 and 2012, yielded 27 items that provide basic guidance to health professionals on human trafficking. EVIDENCE SYNTHESIS: The 27 resources differed substantially in format, length, scope, and intended audience. Topic areas covered by these resources included trafficking definitions and scope, health consequences, victim identification, appropriate treatment, referral to services, legal issues, and security. None of the educational resources has been rigorously evaluated. CONCLUSIONS: There is a clear need to develop, implement, and evaluate high-quality education and training programs that focus on human trafficking for healthcare providers.

Evaluation of a novel training package among frontline maternal, newborn, and child health workers in South Sudan.

OBJECTIVE: To develop, implement, and evaluate an evidence-based Maternal, Newborn, and Child Survival (MNCS) package for frontline health workers (FHWs) in South Sudan. METHODS: A multimodal needs assessment was conducted to develop a best-evidence package comprised of targeted training, pictorial checklists, and reusable equipment and commodities. Implementation utilized a training-of-trainers model. Program effectiveness was assessed through knowledge assessments, objective structured clinical examinations (OSCEs), focus groups, and questionnaires. RESULTS: A total of 72 trainers and 708 FHWs were trained in 7 South Sudan states. Trainer knowledge assessments improved significantly: from 62.7% to 92.0% (P<0.001). Mean FHW scores on maternal OSCEs were 21.1% pre-training, 83.4% post-training, and 61.5% 2-3 months after training (P<0.001). Corresponding mean newborn OSCE scores were 41.6%, 89.8%, and 45.7% (P<0.001). Questionnaires revealed high levels of use, satisfaction, and confidence. FHWs reported an average of 3.0 referrals (range, 0-20) to healthcare facilities during the 2-3 months following training, and 78.3% of FHWs were more likely to refer patients. Seven focus groups showed high satisfaction with trainings, commodities, and checklists, with few barriers. CONCLUSION: The MNCS package has led to improved FHW knowledge, skills, and referral. A novel package of training, checklists, and equipment can be successfully implemented in resource-limited settings and enhance links between community-based providers and healthcare facilities.