- Email: [email protected]
Making cesarean delivery SAFE in low- and middle-income countries
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Available online at www.sciencedirect.com
Seminars in Perinatology www.seminperinat.com
Making cesarean delivery SAFE in low- and middle-income countries Margo S. Harrisona,*, and Robert L. Goldenbergb a
Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Denver, CO, USA Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA
b
A R T I C L E I N F O Keywords: Cesarean birth Low- and middle-income countries Safety Quality Facility-based care
ABSTRA CT Cesarean birth (CB) rates are rising, globally. The global burden of CB is having a mixed effect on pregnancy outcomes and requires significant clinical and economic resources. The context of CB care in low- and middle-income countries is further complicated by barriers to facility-based care itself, followed by issues with quality and delivery of care in these resource-limited settings. The objective of this commentary is to propose an original, new, flexible, comprehensive care model for delivering SAFE cesarean delivery care in very low-resource settings. This model, the SAFE model for cesarean delivery care in low- and middle-income countries, developed by the authors, does not assume the current care model is working. It does not assume that even traditional hospital settings are what is needed to solve the problem of delivering high-quality, easily accessible CB care in the most remote and geographically isolated communities. The novel model promotes a decentralized care program that brings emergency obstetric care to women instead of the converse through four concepts: the care should be cloSe (community-based), it should be very dedicated to Action (transfer of care), it should be Focused on and highly specific to labor and delivery (cesarean birth center), and finally, it should be committed to high-quality care through iterative Evidence-based quality improvement programming and data collection. Ó 2019 Elsevier Inc. All rights reserved.
Introduction Global cesarean birth (CB) rates have doubled in the last 25 years.1 The World Health Organization (WHO) is intently focused on the determinants and implications of this trend for the global community and has a number of publications focused on the appropriate use of CB, generally, and in specific subpopulations.2 6 Of all the healthcare services that exist, CB sits at the intersection of many sectors, not limited to: maternal health, perinatal and child health, social and
behavioral health, public health, healthcare systems/delivery, quality of care, and healthcare economics, as illustrated by Fig. 1. Additionally, while it is certain that CB can save lives, it is also certain that CB can cause harm.2 For low-risk women in particular, cesarean birth is riskier than vaginal birth, and has been identified by the California Maternal Quality Care Collaborative as, “the single, largest barrier to consistently providing high-value, high-quality maternity care”.7 Therefore, finding the appropriate utilization of CB that balances benefits, harms, and resource consumption, is essential.8
Abbreviations: CB, cesarean birth; WHO, World Health Organization; LMIC, low- and middle-income countries; HIC, high-income countries * Corresponding author. Present address: Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO 80045, USA. E-mail address: [email protected] (M.S. Harrison). https://doi.org/10.1053/j.semperi.2019.03.015 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
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SAFE model for cesarean delivery care in low- and middle-income countries: A new paradigm for care cloSe
Fig. 1 – Diagram showing cesarean delivery sitting at the intersection of many sectors.
While the context of care in low- and middle-income countries (LMIC) compared to high-income countries (HIC) is extremely variable, what is consistent across settings is that CB needs to be performed at the right moment, for a medically indicated reason, and with surgical methods that are evidence-based, to reduce adverse outcomes.8 10 The Three Delays Model is a theory that describes challenges women face in trying to access obstetrical care and are described by the model as: (1) a delay in the decision to access care, (2) a delay in transport to a medical facility, and (3) a delay in the receipt of adequate and high-quality medical care.11 The model was meant to apply to women in LMIC, but applies to all women. Women in HIC have mostly overcome the first and second delays to care, but still face the challenge of timely and high-quality CB care in facilities.12 In LMIC, the three delays describes the complexities of CB care in low-resource settings. Any approach to improving utilization and outcomes related to CB has to consider the obstacles a woman faces to even undergo CB— making the decision to seek care in a facility, getting to the facility, and obtaining high-quality obstetric care in a timely fashion.11 The purpose of the SAFE Model for CB care in LMIC, which is a new construct we are proposing with this manuscript, is to create efficiencies in the delivery of CB that result directly in maternal and fetal/neonatal lives saved and morbidity minimized. However, a goal of implementing the program as presented would ideally be to create other efficiencies, such as economic and/or healthcare systematic efficiencies. The model we present in this manuscript promotes a decentralized care program that brings emergency obstetric care to women instead of the converse through four concepts: the care should be cloSe, it should be very focused on Action (transfer of care), it should be highly specific to labor and delivery and therefore should be Focused, and finally, it should be committed to high-quality care through iterative Evidence-based quality improvement programming and routine pregnancy outcomes data collection.
The “S” in SAFE stands for proximity, or making sure that the first level of labor and delivery care is close to women. In order to provide proximate care for women, the SAFE Model espouses the community birth center model, championing the ability of basic birth centers to meet the needs of low-risk women.13 These birth centers, which could be run by midwives, nurses, or even community health workers could be supported out of a community member’s home, a community center, or a stand-alone birth center facility. The goal of the birth center is two-fold: (1) to gain the trust of the surrounding community so that pregnant women want to deliver there, and (2) to serve primarily as a triaging center. The main consideration in setting up birth centers in this way is ensuring the safety of women who labor and deliver there. This not only builds trust but proves that the center can serve as a triaging point for higher levels of care. WHO has provided materials on safe labor and delivery care, the safe childbirth checklist, and components of intrapartum care for a positive childbirth experience that can be used to properly train skilled birth attendants.14 16 If the center is solely focused on low-risk labor and delivery, low- to mid-level providers, such as nurses or properly trained traditional birth attendants, may be able to manage care; this cadre of personnel has been specifically defined by the World Health Organization.17 Additionally, it seems feasible that these birth centers can also leverage mHealth and telehealth to tease out any complexities of patient care they encounter.18 Part of the operating procedures of these community birth centers can be admission criteria, referral criteria, and establishing a contractual support system with a distance on-call provider or labor and delivery center that can be accessed by telephone for clinical assistance.19 The goal of the community birth center is to recognize that many women can deliver safely in a community setting and not all patients must deliver in a facility-based setting. This can be considered level one of facility-based care in that the woman is not in her home, but is in the community “home” or birthing center where a low-level skilled birth attendant can listen to her baby, ask how long she has been in labor, check her urine and blood pressure, screen for warning signs, and set up standard operating procedures and processes for safe, consistent methods of referral. In different settings the skilled birth attendant role can be performed by traditional birth attendants who have undergone basic clinical skills training programs, or nurses.17 The first step in making CB safe in LMIC is to champion the close, community-based birth center that can develop expertise in lowrisk labor and determining when a patient needs referral.17
Action The second step to making CB safe in LMIC is to ensure that the community-based birth centers core mission is to assess and act on behalf of women who are experiencing labor or delivery
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complications. The “A” in SAFE represents action. Part of ensuring the safety of women delivering in a birth center is ensuring that if a woman has met criteria for referral, she can safely deliver elsewhere. The significance of the birth center serving as a triaging center is that it gives an opportunity for a woman’s progress in labor to be assessed and to expedite immediate referral if the woman meets appropriate criteria. Data on the effectiveness of using the partogram is mixed.20 Data on normal progress in labor is also not as definitive as it used to be; determining when a woman needs a higher level of care is unfortunately not an objective assessment.21,22 However, while the details of the labor curve are not entirely clear, especially in different patient populations, what is clear is that the goal of labor and delivery is to deliver a healthy mom and healthy baby. Therefore, we posit that the triaging role of these rudimentary community birth centers is to collect, among other information, at least the following two data points: (1) assess fetal status, and (2) get a basic understanding of how long the woman has been in labor. The providers in these settings can learn to use a fetoscope or low-cost doppler ultrasound to assess the fetus, and can get a sense from the woman or her family when the patient started having painful contractions or rupture of membranes. Referral protocols can be quite a bit more simplistic than the partogram. Referral standards could be as simple as this: (1) if the fetal heart rate is not in the normal range or the fetus is experiencing decelerations with more than half of the contractions, refer the mother for a higher level of care; (2) if the woman has been in labor or had ruptured membranes for greater than 18 h, refer the mother for a higher level of care.23 Obviously if women come in with other warning signs such as lack of a fetal heart rate, heavy vaginal bleeding, preterm labor, fever, or elevated blood pressure, these can also be simple referral standards that are easy to understand and follow, even for a low-level provider. At the patient level, establishing processes that support safe referral can mean counseling patients during antepartum care to prepare for delivery by having a birth plan.24 The birth plan may include preference for labor management methods, but should include specific plans for possible
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transfer during the labor course and strategies for food, childcare, and expenses that may be incurred under a worst-case scenario where the labor becomes complicated. This requires that to deliver safe CB care in LMIC in remote settings, whatever antepartum care that is provided should stress delivering at the close community birth center and preparatory planning for possible transfer if it becomes necessary. The birth center can require a birth plan on admission, helping a woman to formalize her plans per above if, over the course of her labor, she requires referral to a higher level of care. At the birth center level, processes to support referral should be well-established. These can include community-level preparations such as establishing a community managed birth center fund to help pay for patient transfer. It could include having access to (establishing a relationship with a driver) or a taxi (ambulance, tuk-tuk or motorcycle) that can transport the patient. It should include having an established relationship or contract with a facility where women who need a higher level of care can be transferred. A traditional mid-level or high-level hospital is acceptable, but in the upcoming section on providing Focused CD care in LMIC, we suggest a new, decentralized model for facility-based care, as well. In summary, the first component of the SAFE Model is encouraging women to deliver at birth center in their community, which exists to improve patient safety by setting a very low threshold for the second component of the model—acting to refer women to a higher level of care.
Focus In remote geographical locations such as areas of subSaharan Africa, CB rates can be as low as 1%.25,26 Per the World Health Organization, rates of CB between 10 15% are recommended as essential to improve maternal and neonatal mortality, with rates as high as 19% suggested in the literature.2,27 Achieving this goal seems insurmountable in very low resource settings remote from traditional hospitals. For example, within the National Institute of Health funded Global Network for Women’s and Children’s Health Research there is significant variability among LMIC sites on cesarean birth rates, as illustrated by Fig. 2.25
Fig. 2 – Cesarean Section Rates at Global Network site, 2010 2015.
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The “F” in SAFE, which stands for Focus, proposes a novel infrastructure for delivery of emergency obstetrical care in very low-resource areas of low- and middle-income countries. We believe that much as low-risk labor management should be community-based, so should high-risk labor management. Instead of trying to overcome the significant obstacles the Three Delays presents to delivery in a traditional hospital, we assert that healthcare systems in LMIC could establish highly efficient and specific obstetric cesarean birth centers to increase both access to and quality of emergency obstetric care. Data has shown that centers that only perform one specific type of procedure produce excellent health outcomes and surgical results.28 We, therefore, suggest that each community or proximate group of communities have access to a cesarean birth center if they do not have easy access to a traditional hospital setting. It should be noted that if a traditional hospital is easy to access and utilize, the traditional care model may provide better outcomes than the cesarean birth centers proposed in this commentary. One method for establishing such a flexible, accessible infrastructure would be to consider modular, solar-powered clinics such as those produced by Clinic in a Can (Fig 3).29 This organization uses shipping containers to provide an “economical, ready-to-use medical turn-key solution” that is customizable.29 Outfitting a unit to meet specific obstetric needs, such as having a uterotonic crash cart and refrigeration for a small amount of blood products, could be customizable solutions that health systems could consider. Over time, adding an additional shipping container for solar-powered neonatal intensive care could enhance the value of the cesarean birth centers to communities and continue to improve pregnancy outcomes. The goal of the CB-operating room “in a can” is not only to improve access, but concurrently to improve quality. This requires obstetrically trained personnel with specific expertise in CB and CB-related care. Prior research has shown that task-shifting the performance of CB to mid-level providers, or even non-physician medical officers, is possible and outcomes are equivalent to those achieved by more trained
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professionals.30 Many to most LMIC have a scarcity of obstetrician-gynecologists.31 Having generalists or trainees who are not specifically trained in CB provide CB is common practice, especially in remote or low-resource areas.32 However, this can often be associated with performance of low-quality CB that can result in adverse surgical outcomes such as urogenital fistula.33 Accordingly, investing in local community members with the passion, potential, and commitment to provide high-quality surgical care could produce a cadre of trained personnel with obstetric expertise who can run the cesarean birth center. Additionally, receiving specific training would ideally produce individuals not challenged by adverse economic incentives to leave the community once they are properly trained, as their training would be specific to that center and they would not have other clinical training. These obstetric-specific providers would not only be trained to do a CB, but also to know who has met criteria for CB and how to manage complications.23 The third component of the SAFE Model for CB care in LMIC is establishing community-based obstetrical surgi-centers both to increase access to and quality of emergency obstetrical care.
Evidence The “E” in the SAFE Model represents the need for evidence in ensuring that the conceptual model functions as envisioned and provides high-quality care. While we present a model for how CB care can be provided in remote, very low-resource settings, if communities and healthcare systems pursue this model, we recommend a pillar of the process be a rigorous commitment to data collection and evidence-based development and maintenance of the infrastructure. Having a commitment to evidence-based care requires first of all that the model be designed for dissemination.34 This means that the first step in implementation of the SAFE Model is community-based participatory research.35 Engaging community women and their families on what would make them want to deliver at a community-based birth center or what would make them trust engaging with the system would
Fig. 3 – Picture of a mobile clinic.
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be the first step. Interacting with traditional birth attendants or local midwives and nurses about their willingness to undergo training in perfecting their skills in management of low-risk labor and delivery and their comfort with strict referral guidelines would be essential to understanding whether or not the intervention will be designed for success. Determining whether community resources for transfer of women to the cesarean birth center, land for the center, and potential staffing for the center would also be essential data to collect at the initiation of the project. While designing for dissemination and community engagement are essential for the model’s eventual success, it is equally important to design the intervention for success by establishing an effective organization that functions as intended. Establishing a novel community-based labor and delivery system that is community-run is equivalent to creating a new multi-level organization. That organization needs to function smoothly. Mapping and planning out how a woman would get from her home to the community-based birth center, and from there to the community-based cesarean birth center is part of the planning that needs to be considered as the model is developed. Similarly, supply chains, equipment maintenance, staffing structures, and additional infrastructure needs for high-risk women who do not imminently need CB after referral should be considered. Gauging community receptiveness and desire for the SAFE Model and building the SAFE Model infrastructure from scratch should then be followed by detailed data collection on actual utilization of the new system. WHO has suggested institutions track their CB rates using the Robson Classification system, which classifies women undergoing cesarean birth into ten mutually exclusive groups based on basic obstetric characteristics (parity, onset of labor, fetal presentation, number of fetuses, and history of prior cesarean) in order to observe which groups account for the greatest proportion of cesarean births performed, which should certainly be tracked by the proposed cesarean birth centers.36 Additionally, data on women themselves, their sociodemographics, their obstetrical characteristics, their indication for CB, their fetal characteristics, their surgical characteristics, and their pregnancy outcomes is essential information that should be tracked on every woman delivering at the community-based birth center and cesarean birth center. Ongoing data collection gives communities a picture of themselves and their outcomes, and allows for quality improvement and rigorous research. The establishment of regular data reviews creates opportunities for frequent Plan-Do-Study Act quality improvement cycles until quality goals are attained.37 The final component of the SAFE Model is ensuring that evidence-based practices are exercised at every step of implementation—design, organizational development, personnel training, surgical care delivery, and health outcomes monitoring and evaluation.
Final considerations The SAFE Model is a logical, efficient construct that considers the challenges posed to women’s and children’s obstetric health and welfare in very low-resource communities. The challenge is, then, how to get it adopted. As with any health
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intervention, it is essential to prove the safety and efficacy of the model while also designing it for dissemination. This requires pilot data. The best path to adoption is to pilot the study in “ready” communities. A ready community might be one where non-physician providers are already performing cesarean births, but they are doing so in a large, inaccessible hospital that might serve millions of people in a rural region. A ready community is one in which home birth is a common practice and the results of lack of transfer of women experiencing severe complications nearly always results in severe morbidity or mortality. In the communities with the most need, there is ample opportunity to challenge a dysfunctional system with a new paradigm that can be validated and subsequently scaled. To get a centralized healthcare system in a country that might benefit most from this model to adopt the concept might involve the following steps to trial a pilot study: (1) Engage the Chair of obstetrics and gynecology at a preeminent institution in a country where task shifting of cesarean births has already been piloted with non-physician providers; (2) Have that Chair identify a very-low resource environment that is impractically located in relation to that institution where the majority of births occur in the home setting; (3) Identify a location in that community, such as a community center or church, where a room might be allocated to a new birth center; (4) Train a non-physician provider who performs cesarean birth to train community birth attendants on safe labor and delivery practices per WHO guidelines and entrust them with the functioning of the center with strict guidelines as to when patients should be referred to the nonphysician provider; (5) Have the non-physician provider staff the Clinic-In-A-Can cesarean birth center and start to perform communitybased cesarean births for referrals from the birth center. This pilot requires that the “Can” have proper resources and supply chains in place to replenish essential supplies and have access to sterilization materials or a small autoclave. Engaging the community on providing support for the birth center or Can in any way they are able, such as donating time to clean linens, etc., might help sustain the program and engage the community in investing in its own healthcare delivery. Additionally, in order to actually pilot the Can intervention, consideration of health outcomes and implementation science outcomes are essential. Simple data on numbers and types of deliveries, common pregnancy outcomes, and numbers of transfers from the Can to the hospital would be valuable. Additionally, outcomes such as patient and provider satisfaction, process measures on service delivery at the birth center and Can, and objective measures of the quality of care and effectiveness of training birth attendants and non-physician surgeons are essential. What is most important is that the Cans are not causing harm to mothers and babies that might result in worse outcomes as compared to historical data, if any exists. If baseline outcomes do not exist, it may be worth or collecting initial epidemiologic data to which subsequent outcomes data can
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be compared. In summary, to get the SAFE Model adopted, leaders in obstetrics and gynecology in low- and middleincome countries need to be local champions of the concept and pilot the model, designing for dissemination of the model to their entire country into settings where the model is relevant, and setting an example for the rest of the world. With local champions being empowered to disrupt the traditional paradigm of labor and delivery care, so hopefully will we disrupt the traditional outcomes of severe perinatal morbidity and mortality in very low-resource settings where mothers and babies deserve better.
Conclusion In summary, CB is one of the most commonly performed surgeries in the world. Its utilization has outpaced the control or understanding of its appropriate use.2 Because of the potential of CB to cause harm, to be used for economic gain, and to impose a huge resource burden on healthcare systems, it is necessary to establish a model for using it at the right moment, for the right reasons, using the right (high-quality) techniques.2,8,38 Therefore we propose the SAFE Model for Cesarean Delivery Care in Low- and Middle-Income Countries, a comprehensive care model that serves to address the challenge of appropriate and harmless use of CB in very low-resource settings, taking into account not only the three delays that impact a women’s decision to seek and receive care, but also the additional quality-related issues of medically unindicated CB.
Acknowledgments With this work we wish to acknowledge all women in lowand middle-income countries, who have a right to access to high-quality cesarean delivery when medically indicated.
Funding This work is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5K12HD001271-18) and the Doris Duke Charitable Foundation through the primary author.
Authors contributions MSH conceived of the SAFE CD Model with RLG; the authors wrote and edited the manuscript in concert.
Disclosure The authors have no conflicts of interest to disclose.
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29. Clinic in a Can. (http://www.clinicinacan.org/). Accessed 10 November 2018. 30. Pereira C, Cumbi A, Malalane R, Vaz F, McCord C, Bacci A, et al. Meeting the need for emergency obstetric care in Mozambique: work performance and histories of medical doctors and assistant medical officers trained for surgery. BJOG. 2007;114(12):1530–1533. 31. Chu K, Rosseel P, Gielis P, Ford N. Surgical task shifting in subSaharan Africa. PLoS Med. 2009;6(5):e1000078. 32. Bergstrom S. Enhancing Human Resources for Maternal Survival: Task Shifting from Physicians to Non-physicians. Averting Maternal Death and Disability Program, Columbia University; 2008. 33. Alkatib M, Franco AVM, Fynes MM. Vesicouterine fistula following cesarean delivery—ultrasound diagnosis and surgical management. Ultrasound in Obstet Gynecol. 2005. https://doi. org/10.1002/uog.1925. 34. TDR implementation research toolkit. (http://adphealth.org/ irtoolkit/). Accessed 10 November 2018. 35. Minkler M, Wallerstein N. Introduction to community-based participatory research editors. In: Minkler M, Wallerstein N, et al., eds. Community-based Participatory Research for Health, San Fransisco: Jossey-Bass; 2003. 3–26. 36. WHO Robson classification implementation manual. http://apps. who.int/iris/bitstream/handle/10665/259512/9789241513197-eng. pdf?sequence=1. Accessed 10 November 2018. 37. PDSA Worksheet. Instituted for healthcare improvement. (http://www.ihi.org/resources/Pages/Tools/PlanDoStudyActWorksheet.aspx). Accessed 10 November 2018. 38. Gibbons L, Belizan JM, Lauer JA, Betran AP, Merialdi M, Althabe F. The Global Numbers and Cost of Additionally Needed and Unnecessary Caesarean Sections Performed Per Year: Overuse as a Barrier to Universal Coverage. WHO; 2010 http://www.who.int/healthsystems/topics/financing/healthreport/30C-sectioncosts.pdf. Accessed 10 November 2018..
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Available online at www.sciencedirect.com
Seminars in Perinatology www.seminperinat.com
Making cesarean delivery SAFE in low- and middle-income countries Margo S. Harrisona,*, and Robert L. Goldenbergb a
Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Denver, CO, USA Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA
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A R T I C L E I N F O Keywords: Cesarean birth Low- and middle-income countries Safety Quality Facility-based care
ABSTRA CT Cesarean birth (CB) rates are rising, globally. The global burden of CB is having a mixed effect on pregnancy outcomes and requires significant clinical and economic resources. The context of CB care in low- and middle-income countries is further complicated by barriers to facility-based care itself, followed by issues with quality and delivery of care in these resource-limited settings. The objective of this commentary is to propose an original, new, flexible, comprehensive care model for delivering SAFE cesarean delivery care in very low-resource settings. This model, the SAFE model for cesarean delivery care in low- and middle-income countries, developed by the authors, does not assume the current care model is working. It does not assume that even traditional hospital settings are what is needed to solve the problem of delivering high-quality, easily accessible CB care in the most remote and geographically isolated communities. The novel model promotes a decentralized care program that brings emergency obstetric care to women instead of the converse through four concepts: the care should be cloSe (community-based), it should be very dedicated to Action (transfer of care), it should be Focused on and highly specific to labor and delivery (cesarean birth center), and finally, it should be committed to high-quality care through iterative Evidence-based quality improvement programming and data collection. Ó 2019 Elsevier Inc. All rights reserved.
Introduction Global cesarean birth (CB) rates have doubled in the last 25 years.1 The World Health Organization (WHO) is intently focused on the determinants and implications of this trend for the global community and has a number of publications focused on the appropriate use of CB, generally, and in specific subpopulations.2 6 Of all the healthcare services that exist, CB sits at the intersection of many sectors, not limited to: maternal health, perinatal and child health, social and
behavioral health, public health, healthcare systems/delivery, quality of care, and healthcare economics, as illustrated by Fig. 1. Additionally, while it is certain that CB can save lives, it is also certain that CB can cause harm.2 For low-risk women in particular, cesarean birth is riskier than vaginal birth, and has been identified by the California Maternal Quality Care Collaborative as, “the single, largest barrier to consistently providing high-value, high-quality maternity care”.7 Therefore, finding the appropriate utilization of CB that balances benefits, harms, and resource consumption, is essential.8
Abbreviations: CB, cesarean birth; WHO, World Health Organization; LMIC, low- and middle-income countries; HIC, high-income countries * Corresponding author. Present address: Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO 80045, USA. E-mail address: [email protected] (M.S. Harrison). https://doi.org/10.1053/j.semperi.2019.03.015 0146-0005/Ó 2019 Elsevier Inc. All rights reserved.
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SAFE model for cesarean delivery care in low- and middle-income countries: A new paradigm for care cloSe
Fig. 1 – Diagram showing cesarean delivery sitting at the intersection of many sectors.
While the context of care in low- and middle-income countries (LMIC) compared to high-income countries (HIC) is extremely variable, what is consistent across settings is that CB needs to be performed at the right moment, for a medically indicated reason, and with surgical methods that are evidence-based, to reduce adverse outcomes.8 10 The Three Delays Model is a theory that describes challenges women face in trying to access obstetrical care and are described by the model as: (1) a delay in the decision to access care, (2) a delay in transport to a medical facility, and (3) a delay in the receipt of adequate and high-quality medical care.11 The model was meant to apply to women in LMIC, but applies to all women. Women in HIC have mostly overcome the first and second delays to care, but still face the challenge of timely and high-quality CB care in facilities.12 In LMIC, the three delays describes the complexities of CB care in low-resource settings. Any approach to improving utilization and outcomes related to CB has to consider the obstacles a woman faces to even undergo CB— making the decision to seek care in a facility, getting to the facility, and obtaining high-quality obstetric care in a timely fashion.11 The purpose of the SAFE Model for CB care in LMIC, which is a new construct we are proposing with this manuscript, is to create efficiencies in the delivery of CB that result directly in maternal and fetal/neonatal lives saved and morbidity minimized. However, a goal of implementing the program as presented would ideally be to create other efficiencies, such as economic and/or healthcare systematic efficiencies. The model we present in this manuscript promotes a decentralized care program that brings emergency obstetric care to women instead of the converse through four concepts: the care should be cloSe, it should be very focused on Action (transfer of care), it should be highly specific to labor and delivery and therefore should be Focused, and finally, it should be committed to high-quality care through iterative Evidence-based quality improvement programming and routine pregnancy outcomes data collection.
The “S” in SAFE stands for proximity, or making sure that the first level of labor and delivery care is close to women. In order to provide proximate care for women, the SAFE Model espouses the community birth center model, championing the ability of basic birth centers to meet the needs of low-risk women.13 These birth centers, which could be run by midwives, nurses, or even community health workers could be supported out of a community member’s home, a community center, or a stand-alone birth center facility. The goal of the birth center is two-fold: (1) to gain the trust of the surrounding community so that pregnant women want to deliver there, and (2) to serve primarily as a triaging center. The main consideration in setting up birth centers in this way is ensuring the safety of women who labor and deliver there. This not only builds trust but proves that the center can serve as a triaging point for higher levels of care. WHO has provided materials on safe labor and delivery care, the safe childbirth checklist, and components of intrapartum care for a positive childbirth experience that can be used to properly train skilled birth attendants.14 16 If the center is solely focused on low-risk labor and delivery, low- to mid-level providers, such as nurses or properly trained traditional birth attendants, may be able to manage care; this cadre of personnel has been specifically defined by the World Health Organization.17 Additionally, it seems feasible that these birth centers can also leverage mHealth and telehealth to tease out any complexities of patient care they encounter.18 Part of the operating procedures of these community birth centers can be admission criteria, referral criteria, and establishing a contractual support system with a distance on-call provider or labor and delivery center that can be accessed by telephone for clinical assistance.19 The goal of the community birth center is to recognize that many women can deliver safely in a community setting and not all patients must deliver in a facility-based setting. This can be considered level one of facility-based care in that the woman is not in her home, but is in the community “home” or birthing center where a low-level skilled birth attendant can listen to her baby, ask how long she has been in labor, check her urine and blood pressure, screen for warning signs, and set up standard operating procedures and processes for safe, consistent methods of referral. In different settings the skilled birth attendant role can be performed by traditional birth attendants who have undergone basic clinical skills training programs, or nurses.17 The first step in making CB safe in LMIC is to champion the close, community-based birth center that can develop expertise in lowrisk labor and determining when a patient needs referral.17
Action The second step to making CB safe in LMIC is to ensure that the community-based birth centers core mission is to assess and act on behalf of women who are experiencing labor or delivery
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complications. The “A” in SAFE represents action. Part of ensuring the safety of women delivering in a birth center is ensuring that if a woman has met criteria for referral, she can safely deliver elsewhere. The significance of the birth center serving as a triaging center is that it gives an opportunity for a woman’s progress in labor to be assessed and to expedite immediate referral if the woman meets appropriate criteria. Data on the effectiveness of using the partogram is mixed.20 Data on normal progress in labor is also not as definitive as it used to be; determining when a woman needs a higher level of care is unfortunately not an objective assessment.21,22 However, while the details of the labor curve are not entirely clear, especially in different patient populations, what is clear is that the goal of labor and delivery is to deliver a healthy mom and healthy baby. Therefore, we posit that the triaging role of these rudimentary community birth centers is to collect, among other information, at least the following two data points: (1) assess fetal status, and (2) get a basic understanding of how long the woman has been in labor. The providers in these settings can learn to use a fetoscope or low-cost doppler ultrasound to assess the fetus, and can get a sense from the woman or her family when the patient started having painful contractions or rupture of membranes. Referral protocols can be quite a bit more simplistic than the partogram. Referral standards could be as simple as this: (1) if the fetal heart rate is not in the normal range or the fetus is experiencing decelerations with more than half of the contractions, refer the mother for a higher level of care; (2) if the woman has been in labor or had ruptured membranes for greater than 18 h, refer the mother for a higher level of care.23 Obviously if women come in with other warning signs such as lack of a fetal heart rate, heavy vaginal bleeding, preterm labor, fever, or elevated blood pressure, these can also be simple referral standards that are easy to understand and follow, even for a low-level provider. At the patient level, establishing processes that support safe referral can mean counseling patients during antepartum care to prepare for delivery by having a birth plan.24 The birth plan may include preference for labor management methods, but should include specific plans for possible
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transfer during the labor course and strategies for food, childcare, and expenses that may be incurred under a worst-case scenario where the labor becomes complicated. This requires that to deliver safe CB care in LMIC in remote settings, whatever antepartum care that is provided should stress delivering at the close community birth center and preparatory planning for possible transfer if it becomes necessary. The birth center can require a birth plan on admission, helping a woman to formalize her plans per above if, over the course of her labor, she requires referral to a higher level of care. At the birth center level, processes to support referral should be well-established. These can include community-level preparations such as establishing a community managed birth center fund to help pay for patient transfer. It could include having access to (establishing a relationship with a driver) or a taxi (ambulance, tuk-tuk or motorcycle) that can transport the patient. It should include having an established relationship or contract with a facility where women who need a higher level of care can be transferred. A traditional mid-level or high-level hospital is acceptable, but in the upcoming section on providing Focused CD care in LMIC, we suggest a new, decentralized model for facility-based care, as well. In summary, the first component of the SAFE Model is encouraging women to deliver at birth center in their community, which exists to improve patient safety by setting a very low threshold for the second component of the model—acting to refer women to a higher level of care.
Focus In remote geographical locations such as areas of subSaharan Africa, CB rates can be as low as 1%.25,26 Per the World Health Organization, rates of CB between 10 15% are recommended as essential to improve maternal and neonatal mortality, with rates as high as 19% suggested in the literature.2,27 Achieving this goal seems insurmountable in very low resource settings remote from traditional hospitals. For example, within the National Institute of Health funded Global Network for Women’s and Children’s Health Research there is significant variability among LMIC sites on cesarean birth rates, as illustrated by Fig. 2.25
Fig. 2 – Cesarean Section Rates at Global Network site, 2010 2015.
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The “F” in SAFE, which stands for Focus, proposes a novel infrastructure for delivery of emergency obstetrical care in very low-resource areas of low- and middle-income countries. We believe that much as low-risk labor management should be community-based, so should high-risk labor management. Instead of trying to overcome the significant obstacles the Three Delays presents to delivery in a traditional hospital, we assert that healthcare systems in LMIC could establish highly efficient and specific obstetric cesarean birth centers to increase both access to and quality of emergency obstetric care. Data has shown that centers that only perform one specific type of procedure produce excellent health outcomes and surgical results.28 We, therefore, suggest that each community or proximate group of communities have access to a cesarean birth center if they do not have easy access to a traditional hospital setting. It should be noted that if a traditional hospital is easy to access and utilize, the traditional care model may provide better outcomes than the cesarean birth centers proposed in this commentary. One method for establishing such a flexible, accessible infrastructure would be to consider modular, solar-powered clinics such as those produced by Clinic in a Can (Fig 3).29 This organization uses shipping containers to provide an “economical, ready-to-use medical turn-key solution” that is customizable.29 Outfitting a unit to meet specific obstetric needs, such as having a uterotonic crash cart and refrigeration for a small amount of blood products, could be customizable solutions that health systems could consider. Over time, adding an additional shipping container for solar-powered neonatal intensive care could enhance the value of the cesarean birth centers to communities and continue to improve pregnancy outcomes. The goal of the CB-operating room “in a can” is not only to improve access, but concurrently to improve quality. This requires obstetrically trained personnel with specific expertise in CB and CB-related care. Prior research has shown that task-shifting the performance of CB to mid-level providers, or even non-physician medical officers, is possible and outcomes are equivalent to those achieved by more trained
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professionals.30 Many to most LMIC have a scarcity of obstetrician-gynecologists.31 Having generalists or trainees who are not specifically trained in CB provide CB is common practice, especially in remote or low-resource areas.32 However, this can often be associated with performance of low-quality CB that can result in adverse surgical outcomes such as urogenital fistula.33 Accordingly, investing in local community members with the passion, potential, and commitment to provide high-quality surgical care could produce a cadre of trained personnel with obstetric expertise who can run the cesarean birth center. Additionally, receiving specific training would ideally produce individuals not challenged by adverse economic incentives to leave the community once they are properly trained, as their training would be specific to that center and they would not have other clinical training. These obstetric-specific providers would not only be trained to do a CB, but also to know who has met criteria for CB and how to manage complications.23 The third component of the SAFE Model for CB care in LMIC is establishing community-based obstetrical surgi-centers both to increase access to and quality of emergency obstetrical care.
Evidence The “E” in the SAFE Model represents the need for evidence in ensuring that the conceptual model functions as envisioned and provides high-quality care. While we present a model for how CB care can be provided in remote, very low-resource settings, if communities and healthcare systems pursue this model, we recommend a pillar of the process be a rigorous commitment to data collection and evidence-based development and maintenance of the infrastructure. Having a commitment to evidence-based care requires first of all that the model be designed for dissemination.34 This means that the first step in implementation of the SAFE Model is community-based participatory research.35 Engaging community women and their families on what would make them want to deliver at a community-based birth center or what would make them trust engaging with the system would
Fig. 3 – Picture of a mobile clinic.
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be the first step. Interacting with traditional birth attendants or local midwives and nurses about their willingness to undergo training in perfecting their skills in management of low-risk labor and delivery and their comfort with strict referral guidelines would be essential to understanding whether or not the intervention will be designed for success. Determining whether community resources for transfer of women to the cesarean birth center, land for the center, and potential staffing for the center would also be essential data to collect at the initiation of the project. While designing for dissemination and community engagement are essential for the model’s eventual success, it is equally important to design the intervention for success by establishing an effective organization that functions as intended. Establishing a novel community-based labor and delivery system that is community-run is equivalent to creating a new multi-level organization. That organization needs to function smoothly. Mapping and planning out how a woman would get from her home to the community-based birth center, and from there to the community-based cesarean birth center is part of the planning that needs to be considered as the model is developed. Similarly, supply chains, equipment maintenance, staffing structures, and additional infrastructure needs for high-risk women who do not imminently need CB after referral should be considered. Gauging community receptiveness and desire for the SAFE Model and building the SAFE Model infrastructure from scratch should then be followed by detailed data collection on actual utilization of the new system. WHO has suggested institutions track their CB rates using the Robson Classification system, which classifies women undergoing cesarean birth into ten mutually exclusive groups based on basic obstetric characteristics (parity, onset of labor, fetal presentation, number of fetuses, and history of prior cesarean) in order to observe which groups account for the greatest proportion of cesarean births performed, which should certainly be tracked by the proposed cesarean birth centers.36 Additionally, data on women themselves, their sociodemographics, their obstetrical characteristics, their indication for CB, their fetal characteristics, their surgical characteristics, and their pregnancy outcomes is essential information that should be tracked on every woman delivering at the community-based birth center and cesarean birth center. Ongoing data collection gives communities a picture of themselves and their outcomes, and allows for quality improvement and rigorous research. The establishment of regular data reviews creates opportunities for frequent Plan-Do-Study Act quality improvement cycles until quality goals are attained.37 The final component of the SAFE Model is ensuring that evidence-based practices are exercised at every step of implementation—design, organizational development, personnel training, surgical care delivery, and health outcomes monitoring and evaluation.
Final considerations The SAFE Model is a logical, efficient construct that considers the challenges posed to women’s and children’s obstetric health and welfare in very low-resource communities. The challenge is, then, how to get it adopted. As with any health
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intervention, it is essential to prove the safety and efficacy of the model while also designing it for dissemination. This requires pilot data. The best path to adoption is to pilot the study in “ready” communities. A ready community might be one where non-physician providers are already performing cesarean births, but they are doing so in a large, inaccessible hospital that might serve millions of people in a rural region. A ready community is one in which home birth is a common practice and the results of lack of transfer of women experiencing severe complications nearly always results in severe morbidity or mortality. In the communities with the most need, there is ample opportunity to challenge a dysfunctional system with a new paradigm that can be validated and subsequently scaled. To get a centralized healthcare system in a country that might benefit most from this model to adopt the concept might involve the following steps to trial a pilot study: (1) Engage the Chair of obstetrics and gynecology at a preeminent institution in a country where task shifting of cesarean births has already been piloted with non-physician providers; (2) Have that Chair identify a very-low resource environment that is impractically located in relation to that institution where the majority of births occur in the home setting; (3) Identify a location in that community, such as a community center or church, where a room might be allocated to a new birth center; (4) Train a non-physician provider who performs cesarean birth to train community birth attendants on safe labor and delivery practices per WHO guidelines and entrust them with the functioning of the center with strict guidelines as to when patients should be referred to the nonphysician provider; (5) Have the non-physician provider staff the Clinic-In-A-Can cesarean birth center and start to perform communitybased cesarean births for referrals from the birth center. This pilot requires that the “Can” have proper resources and supply chains in place to replenish essential supplies and have access to sterilization materials or a small autoclave. Engaging the community on providing support for the birth center or Can in any way they are able, such as donating time to clean linens, etc., might help sustain the program and engage the community in investing in its own healthcare delivery. Additionally, in order to actually pilot the Can intervention, consideration of health outcomes and implementation science outcomes are essential. Simple data on numbers and types of deliveries, common pregnancy outcomes, and numbers of transfers from the Can to the hospital would be valuable. Additionally, outcomes such as patient and provider satisfaction, process measures on service delivery at the birth center and Can, and objective measures of the quality of care and effectiveness of training birth attendants and non-physician surgeons are essential. What is most important is that the Cans are not causing harm to mothers and babies that might result in worse outcomes as compared to historical data, if any exists. If baseline outcomes do not exist, it may be worth or collecting initial epidemiologic data to which subsequent outcomes data can
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be compared. In summary, to get the SAFE Model adopted, leaders in obstetrics and gynecology in low- and middleincome countries need to be local champions of the concept and pilot the model, designing for dissemination of the model to their entire country into settings where the model is relevant, and setting an example for the rest of the world. With local champions being empowered to disrupt the traditional paradigm of labor and delivery care, so hopefully will we disrupt the traditional outcomes of severe perinatal morbidity and mortality in very low-resource settings where mothers and babies deserve better.
Conclusion In summary, CB is one of the most commonly performed surgeries in the world. Its utilization has outpaced the control or understanding of its appropriate use.2 Because of the potential of CB to cause harm, to be used for economic gain, and to impose a huge resource burden on healthcare systems, it is necessary to establish a model for using it at the right moment, for the right reasons, using the right (high-quality) techniques.2,8,38 Therefore we propose the SAFE Model for Cesarean Delivery Care in Low- and Middle-Income Countries, a comprehensive care model that serves to address the challenge of appropriate and harmless use of CB in very low-resource settings, taking into account not only the three delays that impact a women’s decision to seek and receive care, but also the additional quality-related issues of medically unindicated CB.
Acknowledgments With this work we wish to acknowledge all women in lowand middle-income countries, who have a right to access to high-quality cesarean delivery when medically indicated.
Funding This work is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5K12HD001271-18) and the Doris Duke Charitable Foundation through the primary author.
Authors contributions MSH conceived of the SAFE CD Model with RLG; the authors wrote and edited the manuscript in concert.
Disclosure The authors have no conflicts of interest to disclose.
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