Biftu Mengesha, MD, MAS

The destructive toll COVID-19 has caused worldwide is devastating. In the United States, the disproportionate deaths of Black, Indigenous, and Latinx people due to structural racism, amplified by economic adversity, is unacceptable. Meanwhile, the continued murder of Black people by those sworn to protect the public is abhorrent and can no longer be ignored. Black lives matter. These crises have rightly gripped our attention, and should galvanize physicians individually and collectively to use our privileged voices and relative power for justice. We must strive for engaged, passionate, and innovative leadership deliberately aimed toward antiracism and equity.

The COVID-19 pandemic has illuminated the vast inequities in our country. It has highlighted the continued poor outcomes our health and health care systems create for Black, Indigenous, and Latinx communities. It also has demonstrated clearly that we are all connected—one large community, interdependent yet rife with differential power, privilege, and oppression. We must address these racial disparities—not only in the name of justice and good health for all but also because it is a moral and ethical imperative for us as physicians—and SARS-CoV-2 clearly shows us that it is in the best interest of everyone to do so.

First step: A deep dive look at systemic racism

What is first needed is an examination and acknowledgement by medicine and health care at large of the deeply entrenched roots of systemic and institutional racism in our profession and care systems, and their disproportionate and unjust impact on the health and livelihood of communities of color. The COVID-19 pandemic is only a recent example that highlights the perpetuation of a system that harms people of color. Racism, sexism, gender discrimination, economic and social injustice, religious persecution, and violence against women and children are age-old. We have yet to see health care institutions implement system-wide intersectional and antiracist practices to address them. Mandatory implicit bias training, policies for inclusion and diversity, and position statements are necessary first steps; however, they are not a panacea. They are insufficient to create the bold changes we need. The time for words has long passed. It is time to listen, to hear the cries of anguish and outrage, to examine our privileged position, to embrace change and discomfort, and most importantly to act, and to lead in dismantling the structures around us that perpetuate racial inequity.

How can we, as physicians and leaders, join in action and make an impact?

Dr. Camara Jones, past president of the American Public Health Association, describes 3 levels of racism:

• structural or systemic
• individual or personally mediated
• internalized.

Interventions at each level are important if we are to promote equity in health and health care. This framework can help us think about the following strategic initiatives.

Continue to: 1. Commit to becoming an antiracist and engage in independent study...

1. Commit to becoming antiracist and engage in independent study. This is an important first step as it will form the foundations for interventions—one cannot facilitate change without understanding the matter at hand. This step also may be the most personally challenging step forcing all of us to wrestle with discomfort, sadness, fear, guilt, and a host of other emotional responses. Remember that great change has never been born out of comfort, and the discomfort physicians may experience while unlearning racism and learning antiracism pales in comparison to what communities of color experience daily. We must actively work to unlearn the racist and anti-Black culture that is so deeply woven into every aspect of our existence.

Learn the history that was not given to us as kids in school. Read the brilliant literary works of Black, Indigenous, and Latinx artists and scholars on dismantling racism. Expand our vocabulary and knowledge of core concepts in racism, racial justice, and equity. Examine and reflect on our day-to-day practices. Be vocal in our commitment to antiracism—the time has passed for staying silent. If you are white, facilitate conversations about race with your white colleagues; the inherent power of racism relegates it to an issue that can never be on the table, but it is time to dismantle that power. Learn what acts of meaningful and intentional alliances are and when we need to give up power or privilege to a person of color. We also need to recognize that we as physicians, while leaders in many spaces, are not leaders in the powerful racial justice grassroots movements. We should learn from these movements, follow their lead, and use our privilege to uplift racial justice in our settings.

2. Embrace the current complexities with empathy and humility, finding ways to exercise our civic responsibility to the public with compassion. During the COVID-19 pandemic we have seen the devastation that social isolation, job loss, and illness can create. Suddenly those who could never have imagined themselves without food are waiting hours in their cars for food bank donations or are finding empty shelves in stores. Those who were not safe at home were suddenly imprisoned indefinitely in unsafe situations. Those who were comfortable, well-insured, and healthy are facing an invisible health threat, insecurity, fear, anxiety, and loss. Additionally, our civic institutions are failing. Those of us who always took our right to vote for granted are being forced to stand in hours’-long lines to exercise that right; while those who have been systematically disenfranchised are enduring even greater threats to their constitutional right to exercise their political power, disallowing them to speak for their families and communities and to vote for the justice they deserve. This may be an opportunity to stop blaming victims and recognize the toll that structural and systemic contributions to inequity have created over generations.

3. Meaningfully engage with and advocate for patients. In health and health care, we must begin to engage with the communities we serve and truly listen to their needs, desires, and barriers to care, and respond accordingly. Policies that try to address the social determinants of health without that engagement, and without the acknowledgement of the structural issues that cause them, however well-intentioned, are unlikely to accomplish their goals. We need to advocate as physicians and leaders in our settings for every policy, practice, and procedure to be scrutinized using an antiracist lens. To execute this, we need to:

• ask why clinic and hospital practices are built the way they are and how to make them more reflexive and responsive to individual patient’s needs
• examine what the disproportionate impacts might be on different groups of patients from a systems-level
• be ready to dismantle and/or rebuild something that is exacerbating disparate outcomes and experiences
• advocate for change that is built upon the narratives of patients and their communities.

We should include patients in the creation of hospital policies and guidelines in order to shift power toward them and to be transparent about how the system operates in order to facilitate trust and collaboration that centers patients and communities in the systems created to serve them.

Continue to: 4. Intentionally repair and build trust...

4. Intentionally repair and build trust. To create a safe environment, we must repair what we have broken and earn the trust of communities by uplifting their voices and redistributing our power to them in changing the systems and structures that have, for generations, kept Black, Indigenous, and Latinx people oppressed. Building trust requires first owning our histories of colonization, genocide, and slavery—now turned mass incarceration, debasement, and exploitation—that has existed for centuries. We as physicians need to do an honest examination of how we have eroded the trust of the very communities we care for since our profession’s creation. We need to acknowledge, as a white-dominant profession, the medical experimentation on and exploitation of Black and Brown bodies, and how this formed the foundation for a very valid deep distrust and fear of the medical establishment. We need to recognize how our inherent racial biases continue to feed this distrust, like when we don’t treat patients’ pain adequately or make them feel like we believe and listen to their needs and concerns. We must acknowledge our complicity in perpetuating the racial inequities in health, again highlighted by the COVID-19 pandemic.

5. Increase Black, Indigenous, and Latinx representation in physician and other health care professions’ workforce. Racism impacts not only patients but also our colleagues of color. The lack of racial diversity is a symptom of racism and a representation of the continued exclusion and devaluing of physicians of color. We must recognize this legacy of exclusion and facilitate intentional recruitment, retention, inclusion, and belonging of people of color into our workforce. Tokenism, the act of symbolically including one or few people from underrepresented groups, has been a weapon used by our workforce against physicians of color, resulting in isolation, “othering,” demoralization, and other deleterious impacts. We need to reverse this history and diversify our training programs and workforce to ensure justice in our own community.

6. Design multifaceted interventions. Multilevel problems require multilevel solutions. Interventions targeted solely at one level, while helpful, are unlikely to result in the larger scale changes our society needs to implement if we are to eradicate the impact of racism on health. We have long known that it is not just “preexisting conditions” or “poor” individual behaviors that lead to negative and disparate health outcomes—these are impacted by social and structural determinants much larger and more deleterious than that. It is critically important that we allocate and redistribute resources to create safe and affordable housing; childcare and preschool facilities; healthy, available, and affordable food; equitable and affordable educational opportunities; and a clean environment to support the health of all communities—not only those with the highest tax base. It is imperative that we strive to understand the lives of our fellow human beings who have been subjected to intergenerational social injustices and oppressions that have continued to place them at the margins of society. We need to center the lived experiences of communities of color in the design of multilevel interventions, especially Black and Indigenous communities. While we as physicians cannot individually impact education, economic, or food/environment systems, we can use our power to advocate for providing resources for the patients we care for and can create strategies within the health care system to address these needs in order to achieve optimal health. Robust and equitable social structures are the foundations for health, and ensuring equitable access to them is critical to reducing disparities.

Commit to lead

We must commit to unlearning our internalized racism, rebuilding relationships with communities of color, and engaging in antiracist practices. As a profession dedicated to healing, we have an obligation to be leaders in advocating for these changes, and dismantling the inequitable structure of our health care system.

Our challenge now is to articulate solutions. While antiracism should be informed by the lived experiences of communities of color, the work of antiracism is not their responsibility. In fact, it is the responsibility of our white-dominated systems and institutions to change.

There are some solutions that are easier to enumerate because they have easily measurable outcomes or activities, such as:

• collecting data transparently
• identifying inequities in access, treatment, and care
• conducting rigorous root cause analysis of those barriers to care
• increasing diverse racial and gender representation on decision-making bodies, from board rooms to committees, from leadership teams to research participants
• redistribute power by paving the way for underrepresented colleagues to participate in clinical, administrative, educational, executive, and health policy spaces
• mentoring new leaders who come from marginalized communities.

Every patient deserves our expertise and access to high-quality care. We should review our patient panels to ensure we are taking steps personally to be just and eliminate disparities, and we should monitor the results of those efforts.

Continue to: Be open to solutions that may make us “uncomfortable”...

Be open to solutions that may make us “uncomfortable”

There are other solutions, perhaps those that would be more effective on a larger scale, which may be harder to measure using our traditional ways of inquiry or measurement. Solutions that may create discomfort, anger, or fear for those who have held their power or positions for a long time. We need to begin to engage in developing, cultivating, and valuing innovative strategies that produce equally valid knowledge, evidence, and solutions without engaging in a randomized controlled trial. We need to reinvent the way inquiry, investigation, and implementation are done, and utilize novel, justice-informed strategies that include real-world evidence to produce results that are applicable to all (not just those willing to participate in sponsored trials). Only then will we be able to provide equitable health outcomes for all.

We also must accept responsibility for the past and humbly ask communities to work with us as we struggle to eliminate racism and dehumanization of Black lives by calling out our actions or inaction, recognizing the impact of our privileged status, and stepping down or stepping aside to allow others to lead. Sometimes it is as simple as turning off the Zoom camera so others can talk. By redistributing power and focusing this work upon the narratives of marginalized communities, we can improve our system for everyone. We must lead with action within our practices and systems; become advocates within our communities, institutions, and profession; strategize and organize interventions at both structural and individual levels to first recognize and name—then change—the systems; and unlearn behaviors that perpetuate racism.

Inaction is shirking our responsibility among the medical community

Benign inaction and unintentional acquiescence with “the way things are and have always been” abdicates our responsibility as physicians to improve the health of our patients and our communities. The modern Hippocratic Oath reminds us: “I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.” We have a professional and ethical responsibility to ensure health equity, and thus racial equity. As physicians, as healers, as leaders we must address racial inequities at all levels as we commit to improving the health of our nation. We can no longer stand silent in the face of the violence, brutality, and injustices our patients, friends, family, neighbors, communities, and society as a whole live through daily. It is unjust and inhumane to do so.

To be silent is to be complicit. As Gandhi said so long ago, we must “be the change we wish to see in the world.” And as Ijeoma Olua teaches us, “Anti-racism is the commitment to fight racism wherever you find it, including in yourself. And it’s the only way forward.”
 

The destructive toll COVID-19 has caused worldwide is devastating. In the United States, the disproportionate deaths of Black, Indigenous, and Latinx people due to structural racism, amplified by economic adversity, is unacceptable. Meanwhile, the continued murder of Black people by those sworn to protect the public is abhorrent and can no longer be ignored. Black lives matter. These crises have rightly gripped our attention, and should galvanize physicians individually and collectively to use our privileged voices and relative power for justice. We must strive for engaged, passionate, and innovative leadership deliberately aimed toward antiracism and equity.

The COVID-19 pandemic has illuminated the vast inequities in our country. It has highlighted the continued poor outcomes our health and health care systems create for Black, Indigenous, and Latinx communities. It also has demonstrated clearly that we are all connected—one large community, interdependent yet rife with differential power, privilege, and oppression. We must address these racial disparities—not only in the name of justice and good health for all but also because it is a moral and ethical imperative for us as physicians—and SARS-CoV-2 clearly shows us that it is in the best interest of everyone to do so.

First step: A deep dive look at systemic racism

What is first needed is an examination and acknowledgement by medicine and health care at large of the deeply entrenched roots of systemic and institutional racism in our profession and care systems, and their disproportionate and unjust impact on the health and livelihood of communities of color. The COVID-19 pandemic is only a recent example that highlights the perpetuation of a system that harms people of color. Racism, sexism, gender discrimination, economic and social injustice, religious persecution, and violence against women and children are age-old. We have yet to see health care institutions implement system-wide intersectional and antiracist practices to address them. Mandatory implicit bias training, policies for inclusion and diversity, and position statements are necessary first steps; however, they are not a panacea. They are insufficient to create the bold changes we need. The time for words has long passed. It is time to listen, to hear the cries of anguish and outrage, to examine our privileged position, to embrace change and discomfort, and most importantly to act, and to lead in dismantling the structures around us that perpetuate racial inequity.

How can we, as physicians and leaders, join in action and make an impact?

Dr. Camara Jones, past president of the American Public Health Association, describes 3 levels of racism:

• structural or systemic
• individual or personally mediated
• internalized.

Interventions at each level are important if we are to promote equity in health and health care. This framework can help us think about the following strategic initiatives.

Continue to: 1. Commit to becoming an antiracist and engage in independent study...

1. Commit to becoming antiracist and engage in independent study. This is an important first step as it will form the foundations for interventions—one cannot facilitate change without understanding the matter at hand. This step also may be the most personally challenging step forcing all of us to wrestle with discomfort, sadness, fear, guilt, and a host of other emotional responses. Remember that great change has never been born out of comfort, and the discomfort physicians may experience while unlearning racism and learning antiracism pales in comparison to what communities of color experience daily. We must actively work to unlearn the racist and anti-Black culture that is so deeply woven into every aspect of our existence.

Learn the history that was not given to us as kids in school. Read the brilliant literary works of Black, Indigenous, and Latinx artists and scholars on dismantling racism. Expand our vocabulary and knowledge of core concepts in racism, racial justice, and equity. Examine and reflect on our day-to-day practices. Be vocal in our commitment to antiracism—the time has passed for staying silent. If you are white, facilitate conversations about race with your white colleagues; the inherent power of racism relegates it to an issue that can never be on the table, but it is time to dismantle that power. Learn what acts of meaningful and intentional alliances are and when we need to give up power or privilege to a person of color. We also need to recognize that we as physicians, while leaders in many spaces, are not leaders in the powerful racial justice grassroots movements. We should learn from these movements, follow their lead, and use our privilege to uplift racial justice in our settings.

2. Embrace the current complexities with empathy and humility, finding ways to exercise our civic responsibility to the public with compassion. During the COVID-19 pandemic we have seen the devastation that social isolation, job loss, and illness can create. Suddenly those who could never have imagined themselves without food are waiting hours in their cars for food bank donations or are finding empty shelves in stores. Those who were not safe at home were suddenly imprisoned indefinitely in unsafe situations. Those who were comfortable, well-insured, and healthy are facing an invisible health threat, insecurity, fear, anxiety, and loss. Additionally, our civic institutions are failing. Those of us who always took our right to vote for granted are being forced to stand in hours’-long lines to exercise that right; while those who have been systematically disenfranchised are enduring even greater threats to their constitutional right to exercise their political power, disallowing them to speak for their families and communities and to vote for the justice they deserve. This may be an opportunity to stop blaming victims and recognize the toll that structural and systemic contributions to inequity have created over generations.

3. Meaningfully engage with and advocate for patients. In health and health care, we must begin to engage with the communities we serve and truly listen to their needs, desires, and barriers to care, and respond accordingly. Policies that try to address the social determinants of health without that engagement, and without the acknowledgement of the structural issues that cause them, however well-intentioned, are unlikely to accomplish their goals. We need to advocate as physicians and leaders in our settings for every policy, practice, and procedure to be scrutinized using an antiracist lens. To execute this, we need to:

• ask why clinic and hospital practices are built the way they are and how to make them more reflexive and responsive to individual patient’s needs
• examine what the disproportionate impacts might be on different groups of patients from a systems-level
• be ready to dismantle and/or rebuild something that is exacerbating disparate outcomes and experiences
• advocate for change that is built upon the narratives of patients and their communities.

We should include patients in the creation of hospital policies and guidelines in order to shift power toward them and to be transparent about how the system operates in order to facilitate trust and collaboration that centers patients and communities in the systems created to serve them.

Continue to: 4. Intentionally repair and build trust...

4. Intentionally repair and build trust. To create a safe environment, we must repair what we have broken and earn the trust of communities by uplifting their voices and redistributing our power to them in changing the systems and structures that have, for generations, kept Black, Indigenous, and Latinx people oppressed. Building trust requires first owning our histories of colonization, genocide, and slavery—now turned mass incarceration, debasement, and exploitation—that has existed for centuries. We as physicians need to do an honest examination of how we have eroded the trust of the very communities we care for since our profession’s creation. We need to acknowledge, as a white-dominant profession, the medical experimentation on and exploitation of Black and Brown bodies, and how this formed the foundation for a very valid deep distrust and fear of the medical establishment. We need to recognize how our inherent racial biases continue to feed this distrust, like when we don’t treat patients’ pain adequately or make them feel like we believe and listen to their needs and concerns. We must acknowledge our complicity in perpetuating the racial inequities in health, again highlighted by the COVID-19 pandemic.

5. Increase Black, Indigenous, and Latinx representation in physician and other health care professions’ workforce. Racism impacts not only patients but also our colleagues of color. The lack of racial diversity is a symptom of racism and a representation of the continued exclusion and devaluing of physicians of color. We must recognize this legacy of exclusion and facilitate intentional recruitment, retention, inclusion, and belonging of people of color into our workforce. Tokenism, the act of symbolically including one or few people from underrepresented groups, has been a weapon used by our workforce against physicians of color, resulting in isolation, “othering,” demoralization, and other deleterious impacts. We need to reverse this history and diversify our training programs and workforce to ensure justice in our own community.

6. Design multifaceted interventions. Multilevel problems require multilevel solutions. Interventions targeted solely at one level, while helpful, are unlikely to result in the larger scale changes our society needs to implement if we are to eradicate the impact of racism on health. We have long known that it is not just “preexisting conditions” or “poor” individual behaviors that lead to negative and disparate health outcomes—these are impacted by social and structural determinants much larger and more deleterious than that. It is critically important that we allocate and redistribute resources to create safe and affordable housing; childcare and preschool facilities; healthy, available, and affordable food; equitable and affordable educational opportunities; and a clean environment to support the health of all communities—not only those with the highest tax base. It is imperative that we strive to understand the lives of our fellow human beings who have been subjected to intergenerational social injustices and oppressions that have continued to place them at the margins of society. We need to center the lived experiences of communities of color in the design of multilevel interventions, especially Black and Indigenous communities. While we as physicians cannot individually impact education, economic, or food/environment systems, we can use our power to advocate for providing resources for the patients we care for and can create strategies within the health care system to address these needs in order to achieve optimal health. Robust and equitable social structures are the foundations for health, and ensuring equitable access to them is critical to reducing disparities.

Commit to lead

We must commit to unlearning our internalized racism, rebuilding relationships with communities of color, and engaging in antiracist practices. As a profession dedicated to healing, we have an obligation to be leaders in advocating for these changes, and dismantling the inequitable structure of our health care system.

Our challenge now is to articulate solutions. While antiracism should be informed by the lived experiences of communities of color, the work of antiracism is not their responsibility. In fact, it is the responsibility of our white-dominated systems and institutions to change.

There are some solutions that are easier to enumerate because they have easily measurable outcomes or activities, such as:

• collecting data transparently
• identifying inequities in access, treatment, and care
• conducting rigorous root cause analysis of those barriers to care
• increasing diverse racial and gender representation on decision-making bodies, from board rooms to committees, from leadership teams to research participants
• redistribute power by paving the way for underrepresented colleagues to participate in clinical, administrative, educational, executive, and health policy spaces
• mentoring new leaders who come from marginalized communities.

Every patient deserves our expertise and access to high-quality care. We should review our patient panels to ensure we are taking steps personally to be just and eliminate disparities, and we should monitor the results of those efforts.

Continue to: Be open to solutions that may make us “uncomfortable”...

Be open to solutions that may make us “uncomfortable”

There are other solutions, perhaps those that would be more effective on a larger scale, which may be harder to measure using our traditional ways of inquiry or measurement. Solutions that may create discomfort, anger, or fear for those who have held their power or positions for a long time. We need to begin to engage in developing, cultivating, and valuing innovative strategies that produce equally valid knowledge, evidence, and solutions without engaging in a randomized controlled trial. We need to reinvent the way inquiry, investigation, and implementation are done, and utilize novel, justice-informed strategies that include real-world evidence to produce results that are applicable to all (not just those willing to participate in sponsored trials). Only then will we be able to provide equitable health outcomes for all.

We also must accept responsibility for the past and humbly ask communities to work with us as we struggle to eliminate racism and dehumanization of Black lives by calling out our actions or inaction, recognizing the impact of our privileged status, and stepping down or stepping aside to allow others to lead. Sometimes it is as simple as turning off the Zoom camera so others can talk. By redistributing power and focusing this work upon the narratives of marginalized communities, we can improve our system for everyone. We must lead with action within our practices and systems; become advocates within our communities, institutions, and profession; strategize and organize interventions at both structural and individual levels to first recognize and name—then change—the systems; and unlearn behaviors that perpetuate racism.

Inaction is shirking our responsibility among the medical community

Benign inaction and unintentional acquiescence with “the way things are and have always been” abdicates our responsibility as physicians to improve the health of our patients and our communities. The modern Hippocratic Oath reminds us: “I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.” We have a professional and ethical responsibility to ensure health equity, and thus racial equity. As physicians, as healers, as leaders we must address racial inequities at all levels as we commit to improving the health of our nation. We can no longer stand silent in the face of the violence, brutality, and injustices our patients, friends, family, neighbors, communities, and society as a whole live through daily. It is unjust and inhumane to do so.

To be silent is to be complicit. As Gandhi said so long ago, we must “be the change we wish to see in the world.” And as Ijeoma Olua teaches us, “Anti-racism is the commitment to fight racism wherever you find it, including in yourself. And it’s the only way forward.”
 

The destructive toll COVID-19 has caused worldwide is devastating. In the United States, the disproportionate deaths of Black, Indigenous, and Latinx people due to structural racism, amplified by economic adversity, is unacceptable. Meanwhile, the continued murder of Black people by those sworn to protect the public is abhorrent and can no longer be ignored. Black lives matter. These crises have rightly gripped our attention, and should galvanize physicians individually and collectively to use our privileged voices and relative power for justice. We must strive for engaged, passionate, and innovative leadership deliberately aimed toward antiracism and equity.

The COVID-19 pandemic has illuminated the vast inequities in our country. It has highlighted the continued poor outcomes our health and health care systems create for Black, Indigenous, and Latinx communities. It also has demonstrated clearly that we are all connected—one large community, interdependent yet rife with differential power, privilege, and oppression. We must address these racial disparities—not only in the name of justice and good health for all but also because it is a moral and ethical imperative for us as physicians—and SARS-CoV-2 clearly shows us that it is in the best interest of everyone to do so.

First step: A deep dive look at systemic racism

What is first needed is an examination and acknowledgement by medicine and health care at large of the deeply entrenched roots of systemic and institutional racism in our profession and care systems, and their disproportionate and unjust impact on the health and livelihood of communities of color. The COVID-19 pandemic is only a recent example that highlights the perpetuation of a system that harms people of color. Racism, sexism, gender discrimination, economic and social injustice, religious persecution, and violence against women and children are age-old. We have yet to see health care institutions implement system-wide intersectional and antiracist practices to address them. Mandatory implicit bias training, policies for inclusion and diversity, and position statements are necessary first steps; however, they are not a panacea. They are insufficient to create the bold changes we need. The time for words has long passed. It is time to listen, to hear the cries of anguish and outrage, to examine our privileged position, to embrace change and discomfort, and most importantly to act, and to lead in dismantling the structures around us that perpetuate racial inequity.

How can we, as physicians and leaders, join in action and make an impact?

Dr. Camara Jones, past president of the American Public Health Association, describes 3 levels of racism:

• structural or systemic
• individual or personally mediated
• internalized.

Interventions at each level are important if we are to promote equity in health and health care. This framework can help us think about the following strategic initiatives.

Continue to: 1. Commit to becoming an antiracist and engage in independent study...

1. Commit to becoming antiracist and engage in independent study. This is an important first step as it will form the foundations for interventions—one cannot facilitate change without understanding the matter at hand. This step also may be the most personally challenging step forcing all of us to wrestle with discomfort, sadness, fear, guilt, and a host of other emotional responses. Remember that great change has never been born out of comfort, and the discomfort physicians may experience while unlearning racism and learning antiracism pales in comparison to what communities of color experience daily. We must actively work to unlearn the racist and anti-Black culture that is so deeply woven into every aspect of our existence.

Learn the history that was not given to us as kids in school. Read the brilliant literary works of Black, Indigenous, and Latinx artists and scholars on dismantling racism. Expand our vocabulary and knowledge of core concepts in racism, racial justice, and equity. Examine and reflect on our day-to-day practices. Be vocal in our commitment to antiracism—the time has passed for staying silent. If you are white, facilitate conversations about race with your white colleagues; the inherent power of racism relegates it to an issue that can never be on the table, but it is time to dismantle that power. Learn what acts of meaningful and intentional alliances are and when we need to give up power or privilege to a person of color. We also need to recognize that we as physicians, while leaders in many spaces, are not leaders in the powerful racial justice grassroots movements. We should learn from these movements, follow their lead, and use our privilege to uplift racial justice in our settings.

2. Embrace the current complexities with empathy and humility, finding ways to exercise our civic responsibility to the public with compassion. During the COVID-19 pandemic we have seen the devastation that social isolation, job loss, and illness can create. Suddenly those who could never have imagined themselves without food are waiting hours in their cars for food bank donations or are finding empty shelves in stores. Those who were not safe at home were suddenly imprisoned indefinitely in unsafe situations. Those who were comfortable, well-insured, and healthy are facing an invisible health threat, insecurity, fear, anxiety, and loss. Additionally, our civic institutions are failing. Those of us who always took our right to vote for granted are being forced to stand in hours’-long lines to exercise that right; while those who have been systematically disenfranchised are enduring even greater threats to their constitutional right to exercise their political power, disallowing them to speak for their families and communities and to vote for the justice they deserve. This may be an opportunity to stop blaming victims and recognize the toll that structural and systemic contributions to inequity have created over generations.

3. Meaningfully engage with and advocate for patients. In health and health care, we must begin to engage with the communities we serve and truly listen to their needs, desires, and barriers to care, and respond accordingly. Policies that try to address the social determinants of health without that engagement, and without the acknowledgement of the structural issues that cause them, however well-intentioned, are unlikely to accomplish their goals. We need to advocate as physicians and leaders in our settings for every policy, practice, and procedure to be scrutinized using an antiracist lens. To execute this, we need to:

• ask why clinic and hospital practices are built the way they are and how to make them more reflexive and responsive to individual patient’s needs
• examine what the disproportionate impacts might be on different groups of patients from a systems-level
• be ready to dismantle and/or rebuild something that is exacerbating disparate outcomes and experiences
• advocate for change that is built upon the narratives of patients and their communities.

We should include patients in the creation of hospital policies and guidelines in order to shift power toward them and to be transparent about how the system operates in order to facilitate trust and collaboration that centers patients and communities in the systems created to serve them.

Continue to: 4. Intentionally repair and build trust...

4. Intentionally repair and build trust. To create a safe environment, we must repair what we have broken and earn the trust of communities by uplifting their voices and redistributing our power to them in changing the systems and structures that have, for generations, kept Black, Indigenous, and Latinx people oppressed. Building trust requires first owning our histories of colonization, genocide, and slavery—now turned mass incarceration, debasement, and exploitation—that has existed for centuries. We as physicians need to do an honest examination of how we have eroded the trust of the very communities we care for since our profession’s creation. We need to acknowledge, as a white-dominant profession, the medical experimentation on and exploitation of Black and Brown bodies, and how this formed the foundation for a very valid deep distrust and fear of the medical establishment. We need to recognize how our inherent racial biases continue to feed this distrust, like when we don’t treat patients’ pain adequately or make them feel like we believe and listen to their needs and concerns. We must acknowledge our complicity in perpetuating the racial inequities in health, again highlighted by the COVID-19 pandemic.

5. Increase Black, Indigenous, and Latinx representation in physician and other health care professions’ workforce. Racism impacts not only patients but also our colleagues of color. The lack of racial diversity is a symptom of racism and a representation of the continued exclusion and devaluing of physicians of color. We must recognize this legacy of exclusion and facilitate intentional recruitment, retention, inclusion, and belonging of people of color into our workforce. Tokenism, the act of symbolically including one or few people from underrepresented groups, has been a weapon used by our workforce against physicians of color, resulting in isolation, “othering,” demoralization, and other deleterious impacts. We need to reverse this history and diversify our training programs and workforce to ensure justice in our own community.

6. Design multifaceted interventions. Multilevel problems require multilevel solutions. Interventions targeted solely at one level, while helpful, are unlikely to result in the larger scale changes our society needs to implement if we are to eradicate the impact of racism on health. We have long known that it is not just “preexisting conditions” or “poor” individual behaviors that lead to negative and disparate health outcomes—these are impacted by social and structural determinants much larger and more deleterious than that. It is critically important that we allocate and redistribute resources to create safe and affordable housing; childcare and preschool facilities; healthy, available, and affordable food; equitable and affordable educational opportunities; and a clean environment to support the health of all communities—not only those with the highest tax base. It is imperative that we strive to understand the lives of our fellow human beings who have been subjected to intergenerational social injustices and oppressions that have continued to place them at the margins of society. We need to center the lived experiences of communities of color in the design of multilevel interventions, especially Black and Indigenous communities. While we as physicians cannot individually impact education, economic, or food/environment systems, we can use our power to advocate for providing resources for the patients we care for and can create strategies within the health care system to address these needs in order to achieve optimal health. Robust and equitable social structures are the foundations for health, and ensuring equitable access to them is critical to reducing disparities.

Commit to lead

We must commit to unlearning our internalized racism, rebuilding relationships with communities of color, and engaging in antiracist practices. As a profession dedicated to healing, we have an obligation to be leaders in advocating for these changes, and dismantling the inequitable structure of our health care system.

Our challenge now is to articulate solutions. While antiracism should be informed by the lived experiences of communities of color, the work of antiracism is not their responsibility. In fact, it is the responsibility of our white-dominated systems and institutions to change.

There are some solutions that are easier to enumerate because they have easily measurable outcomes or activities, such as:

• collecting data transparently
• identifying inequities in access, treatment, and care
• conducting rigorous root cause analysis of those barriers to care
• increasing diverse racial and gender representation on decision-making bodies, from board rooms to committees, from leadership teams to research participants
• redistribute power by paving the way for underrepresented colleagues to participate in clinical, administrative, educational, executive, and health policy spaces
• mentoring new leaders who come from marginalized communities.

Every patient deserves our expertise and access to high-quality care. We should review our patient panels to ensure we are taking steps personally to be just and eliminate disparities, and we should monitor the results of those efforts.

Continue to: Be open to solutions that may make us “uncomfortable”...

Be open to solutions that may make us “uncomfortable”

There are other solutions, perhaps those that would be more effective on a larger scale, which may be harder to measure using our traditional ways of inquiry or measurement. Solutions that may create discomfort, anger, or fear for those who have held their power or positions for a long time. We need to begin to engage in developing, cultivating, and valuing innovative strategies that produce equally valid knowledge, evidence, and solutions without engaging in a randomized controlled trial. We need to reinvent the way inquiry, investigation, and implementation are done, and utilize novel, justice-informed strategies that include real-world evidence to produce results that are applicable to all (not just those willing to participate in sponsored trials). Only then will we be able to provide equitable health outcomes for all.

We also must accept responsibility for the past and humbly ask communities to work with us as we struggle to eliminate racism and dehumanization of Black lives by calling out our actions or inaction, recognizing the impact of our privileged status, and stepping down or stepping aside to allow others to lead. Sometimes it is as simple as turning off the Zoom camera so others can talk. By redistributing power and focusing this work upon the narratives of marginalized communities, we can improve our system for everyone. We must lead with action within our practices and systems; become advocates within our communities, institutions, and profession; strategize and organize interventions at both structural and individual levels to first recognize and name—then change—the systems; and unlearn behaviors that perpetuate racism.

Inaction is shirking our responsibility among the medical community

Benign inaction and unintentional acquiescence with “the way things are and have always been” abdicates our responsibility as physicians to improve the health of our patients and our communities. The modern Hippocratic Oath reminds us: “I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.” We have a professional and ethical responsibility to ensure health equity, and thus racial equity. As physicians, as healers, as leaders we must address racial inequities at all levels as we commit to improving the health of our nation. We can no longer stand silent in the face of the violence, brutality, and injustices our patients, friends, family, neighbors, communities, and society as a whole live through daily. It is unjust and inhumane to do so.

To be silent is to be complicit. As Gandhi said so long ago, we must “be the change we wish to see in the world.” And as Ijeoma Olua teaches us, “Anti-racism is the commitment to fight racism wherever you find it, including in yourself. And it’s the only way forward.”
 

Case 1 Induction at 39 weeks in a healthy nulliparous woman

A healthy 35-year-old woman (G1P0) at 39 weeks 0 days and with an uncomplicated pregnancy presents to your office for a routine prenatal visit. She inquires about scheduling an induction of labor, noting that she read a news story about induction at 39 weeks and that it might lower her chance of having a cesarean delivery (CD).

You perform a cervical exam—she is 1 cm dilated, 3 cm long, -2 station, posterior, and firm. You sweep her membranes after obtaining verbal consent. After describing the induction process, you explain that she might be hospitalized for several days before the birth given the need for cervical ripening. “You mean I need to stay in the hospital for the entire process?” she asks incredulously.
 

Over the past 20 years, the percentage of patients undergoing induction of labor (IOL) has increased from 10% to 25%.¹ This percentage likely will rise over time, particularly in the wake of a recent randomized controlled trial suggesting potential maternal benefits, such as reduced CD rate, for nulliparas induced at 39 weeks compared with expectant management.² Although there have not been any changes to guidelines for timing of IOL from such professional societies such as the American College of Obstetricians and Gynecologists (ACOG) or the Society for Maternal-Fetal Medicine, key considerations of rising IOL volume include patient experience, labor and delivery (L&D) units’ capacity and resources, and associated health care costs.

An essential part of successful induction involves patience. Induction can be a lengthy process, particularly for nulliparas with unripe cervices. Cervical ripening is a necessary component of successful labor induction, whether achieved mechanically or pharmacologically with synthetic prostaglandins, and it has been shown to lower the chance of CD.^3,4 However, achieving a ripe cervix is often the lengthiest part of an induction, and not uncommonly consumes 12 to 24 hours or more of inpatient time. Investigators have sought ways to make this process more expeditious. For example, the FOR-MOMI trial demonstrated that the induction-to-delivery time was several hours shorter when cervical ripening combined mechanical and pharmacologic approaches (Foley balloon plus misoprostol), compared with either method alone, without any increase in maternal or fetal complication rates.⁵

Better yet, what if admission to the L&D unit for IOL at term could be deferred until the cervix is ripe? A number of hospitals in the United States have successfully introduced outpatient cervical ripening, and several small observational and randomized controlled trials have reported good results in terms of safety, efficacy and time saved, and patient experience. Here, we will make the case that outpatient cervical ripening should be the standard of care for low-risk pregnancies.

Mechanical cervical ripening

Safety

Although data are limited on the safety, the authors of an ACOG Practice Bulletin suggest that, based on the available evidence of mechanical ripening in an inpatient setting, it is also appropriate in the outpatient setting.⁶ Unlike cervical ripening using prostaglandins, mechanical ripening is not associated with tachysystole, fetal intolerance of labor, or meconium staining.³ A cohort study of nearly 2,000 low-risk patients who underwent Foley catheter placement for cervical ripening using an outpatient protocol but monitored overnight as inpatients and evaluated for adverse outcomes found no CD for fetal distress, vaginal bleeding, placental abruption, or intrapartum stillbirth.⁷ The authors posited that, given this safety profile in the inpatient setting, that mechanical cervical ripening with a Foley catheter would be appropriate for outpatient use in low-risk populations. Other systematic reviews have been reassuring as well, with exceedingly low complication rates during inpatient mechanical cervical ripening.⁸ These data advocate for the evaluation of cervical ripening in the outpatient setting.

The evidence for outpatient mechanical ripening, although again limited, also has demonstrated safety. There does not appear to be an increased rate of maternal or neonatal complications, including infectious morbidity, postpartum hemorrhage, CD, operative vaginal delivery, or fetal distress.^9-12

Continue to: Efficacy and length-of-stay...

Efficacy and length-of-stay

Efficacy also generally has been shown to be similar when mechanical methods are used in the inpatient and outpatient settings. Small randomized trials of outpatient versus inpatient Foley catheter ripening have shown decreased length of stay (by 10 to 13 hours) and similar or less oxytocin use in the outpatient groups, as well as similar Bishop scores after cervical ripening and no difference in maternal or fetal outcomes.^9,11,13,14

One major concern with increasing IOL prevalence is the availability of hospital resources and the associated health care costs, given the known increased length of inpatient stay due to cervical ripening time. Admission to an L&D unit is resource intensive; the costs are similar to admission to an intensive care unit in many hospitals given its level of acuity and high nurse/patient ratio. However, given the safety of outpatient mechanical cervical ripening described above, we argue that routinely admitting low-risk patients for mechanical ripening constitutes a suboptimal use of costly resources.

Indeed, data suggest significant inpatient time savings if cervical ripening can be accomplished prior to admission. A cost-effectiveness analysis in the Netherlands demonstrated a nearly 1,000-euro decrease in cost per induction when Foley catheter induction was done on an outpatient basis.¹⁵ Interestingly, a recent trial confined to multiparas found no differences in hospital time when comparing outpatient ripening with Foley balloon alone with inpatient ripening with Foley balloon plus simultaneous oxytocin.¹⁰ This certainly merits further study, but it may be that the largest time- and cost-savings are among nulliparas.

Patient preferences

Relatively few studies specifically have addressed patient experiences with outpatient versus inpatient mechanical cervical ripening. Outpatient cervical ripening may provide patients with the benefits of being in the comfort of their own homes with their preferred support persons, increased mobility, more bodily autonomy, and satisfaction with their birthing process.

In a pilot trial involving 48 women, inpatient was compared with outpatient cervical ripening using a Foley balloon. Those in the outpatient group reported getting more rest, feeling less isolated, and having enough privacy. However, participants in both groups were equally satisfied and equally likely to recommend their method of induction to others.¹¹ Another study comparing outpatient versus inpatient Foley balloon cervical ripening found that 85% of patients who underwent outpatient ripening were satisfied with the induction method; however, no query or comparison was done with the inpatient group.¹² A trial comparing outpatient mechanical cervical ripening with inpatient misoprostol found that outpatient participants reported several hours more sleep and less pain.¹⁶ And in a discrete choice experiment of British gravidas, participants favored the option of outpatient cervical ripening, even if it meant an extra 1.4 trips to the hospital and over an hour of extra travel time.¹⁷

While these preliminary findings provide some insight that patients may prefer an outpatient approach to cervical ripening, more studies are needed to fully evaluate patient desires.

Continue to: Our approach to mechanical cervical ripening...

Our approach to mechanical cervical ripening

Most patients undergoing scheduled IOL are reasonable candidates for outpatient cervical ripening based on safety and efficacy. By definition, scheduling in advance implies that the provider has determined that outpatient management is reasonable until that date, and the plan for outpatient ripening need not prolong this period.

FIGURES 1 and 2 show protocols for our 2 hospital centers, which regularly allow for outpatient mechanical cervical ripening. In the process of protocol development, we identified absolute and relative contraindications to determine appropriate candidates. We exclude women who require inpatient management of medical or obstetric conditions (for example, women with severe preeclampsia or any condition requiring continuous fetal monitoring). We also do not routinely recommend outpatient cervical ripening to patients who do not have the necessary social conditions to make this process as safe as possible (including stable housing, reliable transportation, and a support person), although this occurs with some exceptions depending on individual patient situations.

Some examples of ideal candidates for outpatient mechanical cervical ripening include those undergoing elective or routine prolonged gestation inductions, or inductions for well-controlled, stable conditions (chronic hypertension and gestational diabetes). At one center, after thorough counseling and assessment, outpatient cervical ripening is also offered to patients with mild risk factors, including twins, prior low transverse CD, stable preeclampsia without severe features, isolated oligohydramnios with otherwise reassuring fetal status, and other similar conditions.

After mechanical cervical ripening placement (either Foley catheter or mechanical dilators), the clinician completes a postprocedure safety checklist and detailed procedure documentation, including number and type of foreign bodies placed. If there are any concerns regarding maternal or fetal well-being, the patient is sent to L&D for evaluation. If the procedure was tolerated well, the patient is discharged home, after a reactive postprocedure nonstress test is done, with detailed instructions for self-care, as well as with a list of symptoms that warrant prompt evaluation prior to scheduled induction time. In a large California hospital group following a similar protocol, only about 5% of women presented in labor before their scheduled induction.¹⁸

Case 2 Cervical ripening for labor preparation in low-risk pregnancy

A 32-year-old woman (G1P0) with an uncomplicated pregnancy at 40 weeks and 3 days presents to your office for a routine prenatal visit. Her vital signs are normal, and her fetus is vertex with an estimated fetal weight of 7.5 lb by Leopald’s maneuvers. You perform a cervical exam and find that her cervix is closed, long, and posterior.

You discuss with her your recommendation for induction of labor by 41 weeks, and she agrees. You also discuss the need for cervical ripening and recommend misoprostol given her closed cervix. You explain that several doses may be needed to get her cervix ready for labor, and she asks, “Do I have to stay in the hospital that whole time?”

Pharmacologic cervical ripening

Efficacy

There are multiple pharmacologic agents that can be used for ripening an unfavorable cervix. The main agents used in the United States are prostaglandins, either PGE1 (oral or vaginal misoprostol) or PGE2 in a gel or sustained-release vaginal insert (dinoprostone).

Outpatient misoprostol to avoid labor induction. Many studies have looked at outpatient misoprostol use as a “prophylactic measure” (to prevent the need for labor induction). For example, Gaffaney and colleagues showed that administering outpatient oral misoprostol (100 µg every 24 hours for up to 3 doses) after 40 weeks’ gestation to women with an unfavorable cervix significantly decreased the time to delivery by a day and a half.¹⁹ Similarly, PonMalar and colleagues demonstrated that administering 25 µg of vaginal misoprostol in a single dose as an outpatient after stripping the membranes significantly reduced time to delivery by 2 days.²⁰ And Stitely and colleagues found a significant reduction in the need for labor induction with the use of outpatient vaginal misoprostol. They administered up to 2 doses of misoprostol 25 µg vaginally every 24 hours for the 48 hours prior to a scheduled postdates induction and found a large reduction in the need for labor induction (11% vs 85%; P<.01).²¹

Continue to: Multiple protocols and regimens...

Multiple protocols and regimens have been studied but, overall, the findings suggest that administering outpatient misoprostol may shorten the time interval to spontaneous labor and decrease the need for a formal labor induction.^19-23

Inpatient compared with outpatient prostaglandin use. These trials of “prophylactic” misoprostol generally have compared outpatient administration of misoprostol with placebo. Prostaglandins are one of the most common methods of inpatient cervical ripening, so what about comparisons of inpatient cervical ripening with outpatient prostaglandin administration? There are a handful of studies that make this comparison.

Chang and colleagues looked retrospectively at inpatient and outpatient misoprostol and found that outpatient administration saved 3 to 5 hours on labor and delivery.²⁴ Biem and colleagues randomly assigned women to either inpatient cervical ripening with PGE2 intravaginal inserts or 1 hour of inpatient monitoring after PGE2 administration and then outpatient discharge until the onset of labor or for a nonstress test at 12 hours. They found that those who underwent outpatient ripening spent 8 hours less on labor and delivery and were more highly satisfied with the initial 12 hours of labor induction experience (56% vs 39%; P<.01).²⁵

The largest randomized controlled trial conducted to study outpatient prostaglandin use was the OPRA study (involving 827 women). Investigators compared inpatient to outpatient PGE2 intravaginal gel.²⁶ The primary outcome was total oxytocin administration, which was not different between groups. The study was underpowered, however, as 50% of women labored spontaneously postrandomization. But in the outpatient arm, less than half of the women required additional inpatient ripening, and nearly 40% returned in spontaneous labor, suggesting that outpatient prostaglandin administration may indeed save women a significant amount of time on labor and delivery.

Safety

The safety of outpatient administration of prostaglandins is the biggest concern, especially since, when prostaglandins are compared to outpatient Foley catheter use, Foleys are overall associated with less tachysystole, fetal intolerance, and meconium-stained fluid.³ Foley catheter use for cervical ripening may not be an appropriate choice for all patients, however. For instance, our case patient has a closed cervix, which could make Foley insertion uncomfortable or even impossible. Misoprostol use also offers the potential for flexibility in cervical ripening protocols as patients need not return for Foley balloon removal and indeed labor induction need not take place immediately after administration of misoprostol.

Patients also may prefer outpatient cervical ripening with misoprostol over a Foley. There are some data to suggest that women, overall, have a preference toward prostaglandins; in the PROBAAT-II trial, which compared inpatient oral misoprostol to Foley catheter for cervical ripening, 12% of women in the Foley arm would have preferred another method of induction (vs 6% in the misoprostol arm; P = .02).²⁷ This preference may be magnified in an outpatient setting.

But, again, is outpatient administration of prostaglandins safe? The published trials thus far have not reported an increase in out-of-hospital deliveries or adverse fetal outcomes. However, studies have been of limited size to see more rare outcomes. Unfortunately, an adequately powered study to demonstrate safety is likely never to be accomplished, given that if used responsibly (in low-risk patients with adequate monitoring after administration) the incidence of adverse fetal outcomes during the at-home portion of cervical ripening is likely to be very low. With responsible use, outpatient administration of prostaglandins should be safe. Women are monitored after misoprostol administration and are not sent home if there are any concerns for fetal distress or if frequent contractions continue. Misoprostol reaches maximum blood concentration 30 minutes after oral administration and 70 to 80 minutes after vaginal administration.²⁸ After this time, if contractions start to intensify it is likely that misoprostol has triggered spontaneous labor. In this setting, women are routinely allowed to spontaneously labor at home. One may even argue that outpatient misoprostol could lead to improved safety, as women essentially have a contraction stress test prior to spontaneous labor, and misoprostol administration as an outpatient, as opposed to as an inpatient, may allow for longer time intervals between doses, which could prevent dose stacking.

Continue to: Our approach to pharmacologic cervical ripening...

Our approach to pharmacologic cervical ripening

Our hospital has been conducting outpatient cervical ripening using vaginal misoprostol for more than 15 years without any known adverse safety concerns (FIGURE 3). Women with a low-risk, singleton pregnancy between 39+0 and 40+6 weeks are potential candidates for outpatient ripening. The majority of outpatient inductions are done electively without any medical indication. Women with stable, minor risk factors (such as diet-controlled gestational diabetes) also may be candidates at their clinician’s discretion. Patients are monitored either in our L&D triage area or in our outpatient antenatal unit; both units are in the same building. One clinician offers outpatient misoprostol in the office, across the street from L&D. We allow for clinician flexibility after administration. Some clinicians do 1 or 2 doses of outpatient cervical ripening in a day prior to a scheduled inpatient induction the next day. Some do multiple daily doses over the course of a week.

Conclusion

While the data continue to be limited, we strongly believe there is sufficient quality evidence from a safety and efficacy perspective to support implementation and evaluation of outpatient cervical ripening protocols for low-risk pregnancies. In the setting of renewed commitments to reducing suboptimal health care costs and utilization as well as increasing patient satisfaction and control in their birthing experiences, we posit it is the responsibility of obstetricians, L&D leadership, and health care institutions to explore the implementation of outpatient cervical ripening for appropriate candidates in their settings.

Case 1 Induction at 39 weeks in a healthy nulliparous woman

A healthy 35-year-old woman (G1P0) at 39 weeks 0 days and with an uncomplicated pregnancy presents to your office for a routine prenatal visit. She inquires about scheduling an induction of labor, noting that she read a news story about induction at 39 weeks and that it might lower her chance of having a cesarean delivery (CD).

You perform a cervical exam—she is 1 cm dilated, 3 cm long, -2 station, posterior, and firm. You sweep her membranes after obtaining verbal consent. After describing the induction process, you explain that she might be hospitalized for several days before the birth given the need for cervical ripening. “You mean I need to stay in the hospital for the entire process?” she asks incredulously.
 

Over the past 20 years, the percentage of patients undergoing induction of labor (IOL) has increased from 10% to 25%.¹ This percentage likely will rise over time, particularly in the wake of a recent randomized controlled trial suggesting potential maternal benefits, such as reduced CD rate, for nulliparas induced at 39 weeks compared with expectant management.² Although there have not been any changes to guidelines for timing of IOL from such professional societies such as the American College of Obstetricians and Gynecologists (ACOG) or the Society for Maternal-Fetal Medicine, key considerations of rising IOL volume include patient experience, labor and delivery (L&D) units’ capacity and resources, and associated health care costs.

An essential part of successful induction involves patience. Induction can be a lengthy process, particularly for nulliparas with unripe cervices. Cervical ripening is a necessary component of successful labor induction, whether achieved mechanically or pharmacologically with synthetic prostaglandins, and it has been shown to lower the chance of CD.^3,4 However, achieving a ripe cervix is often the lengthiest part of an induction, and not uncommonly consumes 12 to 24 hours or more of inpatient time. Investigators have sought ways to make this process more expeditious. For example, the FOR-MOMI trial demonstrated that the induction-to-delivery time was several hours shorter when cervical ripening combined mechanical and pharmacologic approaches (Foley balloon plus misoprostol), compared with either method alone, without any increase in maternal or fetal complication rates.⁵

Better yet, what if admission to the L&D unit for IOL at term could be deferred until the cervix is ripe? A number of hospitals in the United States have successfully introduced outpatient cervical ripening, and several small observational and randomized controlled trials have reported good results in terms of safety, efficacy and time saved, and patient experience. Here, we will make the case that outpatient cervical ripening should be the standard of care for low-risk pregnancies.

Mechanical cervical ripening

Safety

Although data are limited on the safety, the authors of an ACOG Practice Bulletin suggest that, based on the available evidence of mechanical ripening in an inpatient setting, it is also appropriate in the outpatient setting.⁶ Unlike cervical ripening using prostaglandins, mechanical ripening is not associated with tachysystole, fetal intolerance of labor, or meconium staining.³ A cohort study of nearly 2,000 low-risk patients who underwent Foley catheter placement for cervical ripening using an outpatient protocol but monitored overnight as inpatients and evaluated for adverse outcomes found no CD for fetal distress, vaginal bleeding, placental abruption, or intrapartum stillbirth.⁷ The authors posited that, given this safety profile in the inpatient setting, that mechanical cervical ripening with a Foley catheter would be appropriate for outpatient use in low-risk populations. Other systematic reviews have been reassuring as well, with exceedingly low complication rates during inpatient mechanical cervical ripening.⁸ These data advocate for the evaluation of cervical ripening in the outpatient setting.

The evidence for outpatient mechanical ripening, although again limited, also has demonstrated safety. There does not appear to be an increased rate of maternal or neonatal complications, including infectious morbidity, postpartum hemorrhage, CD, operative vaginal delivery, or fetal distress.^9-12

Continue to: Efficacy and length-of-stay...

Efficacy and length-of-stay

Efficacy also generally has been shown to be similar when mechanical methods are used in the inpatient and outpatient settings. Small randomized trials of outpatient versus inpatient Foley catheter ripening have shown decreased length of stay (by 10 to 13 hours) and similar or less oxytocin use in the outpatient groups, as well as similar Bishop scores after cervical ripening and no difference in maternal or fetal outcomes.^9,11,13,14

One major concern with increasing IOL prevalence is the availability of hospital resources and the associated health care costs, given the known increased length of inpatient stay due to cervical ripening time. Admission to an L&D unit is resource intensive; the costs are similar to admission to an intensive care unit in many hospitals given its level of acuity and high nurse/patient ratio. However, given the safety of outpatient mechanical cervical ripening described above, we argue that routinely admitting low-risk patients for mechanical ripening constitutes a suboptimal use of costly resources.

Indeed, data suggest significant inpatient time savings if cervical ripening can be accomplished prior to admission. A cost-effectiveness analysis in the Netherlands demonstrated a nearly 1,000-euro decrease in cost per induction when Foley catheter induction was done on an outpatient basis.¹⁵ Interestingly, a recent trial confined to multiparas found no differences in hospital time when comparing outpatient ripening with Foley balloon alone with inpatient ripening with Foley balloon plus simultaneous oxytocin.¹⁰ This certainly merits further study, but it may be that the largest time- and cost-savings are among nulliparas.

Patient preferences

Relatively few studies specifically have addressed patient experiences with outpatient versus inpatient mechanical cervical ripening. Outpatient cervical ripening may provide patients with the benefits of being in the comfort of their own homes with their preferred support persons, increased mobility, more bodily autonomy, and satisfaction with their birthing process.

In a pilot trial involving 48 women, inpatient was compared with outpatient cervical ripening using a Foley balloon. Those in the outpatient group reported getting more rest, feeling less isolated, and having enough privacy. However, participants in both groups were equally satisfied and equally likely to recommend their method of induction to others.¹¹ Another study comparing outpatient versus inpatient Foley balloon cervical ripening found that 85% of patients who underwent outpatient ripening were satisfied with the induction method; however, no query or comparison was done with the inpatient group.¹² A trial comparing outpatient mechanical cervical ripening with inpatient misoprostol found that outpatient participants reported several hours more sleep and less pain.¹⁶ And in a discrete choice experiment of British gravidas, participants favored the option of outpatient cervical ripening, even if it meant an extra 1.4 trips to the hospital and over an hour of extra travel time.¹⁷

While these preliminary findings provide some insight that patients may prefer an outpatient approach to cervical ripening, more studies are needed to fully evaluate patient desires.

Continue to: Our approach to mechanical cervical ripening...

Our approach to mechanical cervical ripening

Most patients undergoing scheduled IOL are reasonable candidates for outpatient cervical ripening based on safety and efficacy. By definition, scheduling in advance implies that the provider has determined that outpatient management is reasonable until that date, and the plan for outpatient ripening need not prolong this period.

FIGURES 1 and 2 show protocols for our 2 hospital centers, which regularly allow for outpatient mechanical cervical ripening. In the process of protocol development, we identified absolute and relative contraindications to determine appropriate candidates. We exclude women who require inpatient management of medical or obstetric conditions (for example, women with severe preeclampsia or any condition requiring continuous fetal monitoring). We also do not routinely recommend outpatient cervical ripening to patients who do not have the necessary social conditions to make this process as safe as possible (including stable housing, reliable transportation, and a support person), although this occurs with some exceptions depending on individual patient situations.

Some examples of ideal candidates for outpatient mechanical cervical ripening include those undergoing elective or routine prolonged gestation inductions, or inductions for well-controlled, stable conditions (chronic hypertension and gestational diabetes). At one center, after thorough counseling and assessment, outpatient cervical ripening is also offered to patients with mild risk factors, including twins, prior low transverse CD, stable preeclampsia without severe features, isolated oligohydramnios with otherwise reassuring fetal status, and other similar conditions.

After mechanical cervical ripening placement (either Foley catheter or mechanical dilators), the clinician completes a postprocedure safety checklist and detailed procedure documentation, including number and type of foreign bodies placed. If there are any concerns regarding maternal or fetal well-being, the patient is sent to L&D for evaluation. If the procedure was tolerated well, the patient is discharged home, after a reactive postprocedure nonstress test is done, with detailed instructions for self-care, as well as with a list of symptoms that warrant prompt evaluation prior to scheduled induction time. In a large California hospital group following a similar protocol, only about 5% of women presented in labor before their scheduled induction.¹⁸

Case 2 Cervical ripening for labor preparation in low-risk pregnancy

A 32-year-old woman (G1P0) with an uncomplicated pregnancy at 40 weeks and 3 days presents to your office for a routine prenatal visit. Her vital signs are normal, and her fetus is vertex with an estimated fetal weight of 7.5 lb by Leopald’s maneuvers. You perform a cervical exam and find that her cervix is closed, long, and posterior.

You discuss with her your recommendation for induction of labor by 41 weeks, and she agrees. You also discuss the need for cervical ripening and recommend misoprostol given her closed cervix. You explain that several doses may be needed to get her cervix ready for labor, and she asks, “Do I have to stay in the hospital that whole time?”

Pharmacologic cervical ripening

Efficacy

There are multiple pharmacologic agents that can be used for ripening an unfavorable cervix. The main agents used in the United States are prostaglandins, either PGE1 (oral or vaginal misoprostol) or PGE2 in a gel or sustained-release vaginal insert (dinoprostone).

Outpatient misoprostol to avoid labor induction. Many studies have looked at outpatient misoprostol use as a “prophylactic measure” (to prevent the need for labor induction). For example, Gaffaney and colleagues showed that administering outpatient oral misoprostol (100 µg every 24 hours for up to 3 doses) after 40 weeks’ gestation to women with an unfavorable cervix significantly decreased the time to delivery by a day and a half.¹⁹ Similarly, PonMalar and colleagues demonstrated that administering 25 µg of vaginal misoprostol in a single dose as an outpatient after stripping the membranes significantly reduced time to delivery by 2 days.²⁰ And Stitely and colleagues found a significant reduction in the need for labor induction with the use of outpatient vaginal misoprostol. They administered up to 2 doses of misoprostol 25 µg vaginally every 24 hours for the 48 hours prior to a scheduled postdates induction and found a large reduction in the need for labor induction (11% vs 85%; P<.01).²¹

Continue to: Multiple protocols and regimens...

Multiple protocols and regimens have been studied but, overall, the findings suggest that administering outpatient misoprostol may shorten the time interval to spontaneous labor and decrease the need for a formal labor induction.^19-23

Inpatient compared with outpatient prostaglandin use. These trials of “prophylactic” misoprostol generally have compared outpatient administration of misoprostol with placebo. Prostaglandins are one of the most common methods of inpatient cervical ripening, so what about comparisons of inpatient cervical ripening with outpatient prostaglandin administration? There are a handful of studies that make this comparison.

Chang and colleagues looked retrospectively at inpatient and outpatient misoprostol and found that outpatient administration saved 3 to 5 hours on labor and delivery.²⁴ Biem and colleagues randomly assigned women to either inpatient cervical ripening with PGE2 intravaginal inserts or 1 hour of inpatient monitoring after PGE2 administration and then outpatient discharge until the onset of labor or for a nonstress test at 12 hours. They found that those who underwent outpatient ripening spent 8 hours less on labor and delivery and were more highly satisfied with the initial 12 hours of labor induction experience (56% vs 39%; P<.01).²⁵

The largest randomized controlled trial conducted to study outpatient prostaglandin use was the OPRA study (involving 827 women). Investigators compared inpatient to outpatient PGE2 intravaginal gel.²⁶ The primary outcome was total oxytocin administration, which was not different between groups. The study was underpowered, however, as 50% of women labored spontaneously postrandomization. But in the outpatient arm, less than half of the women required additional inpatient ripening, and nearly 40% returned in spontaneous labor, suggesting that outpatient prostaglandin administration may indeed save women a significant amount of time on labor and delivery.

Safety

The safety of outpatient administration of prostaglandins is the biggest concern, especially since, when prostaglandins are compared to outpatient Foley catheter use, Foleys are overall associated with less tachysystole, fetal intolerance, and meconium-stained fluid.³ Foley catheter use for cervical ripening may not be an appropriate choice for all patients, however. For instance, our case patient has a closed cervix, which could make Foley insertion uncomfortable or even impossible. Misoprostol use also offers the potential for flexibility in cervical ripening protocols as patients need not return for Foley balloon removal and indeed labor induction need not take place immediately after administration of misoprostol.

Patients also may prefer outpatient cervical ripening with misoprostol over a Foley. There are some data to suggest that women, overall, have a preference toward prostaglandins; in the PROBAAT-II trial, which compared inpatient oral misoprostol to Foley catheter for cervical ripening, 12% of women in the Foley arm would have preferred another method of induction (vs 6% in the misoprostol arm; P = .02).²⁷ This preference may be magnified in an outpatient setting.

But, again, is outpatient administration of prostaglandins safe? The published trials thus far have not reported an increase in out-of-hospital deliveries or adverse fetal outcomes. However, studies have been of limited size to see more rare outcomes. Unfortunately, an adequately powered study to demonstrate safety is likely never to be accomplished, given that if used responsibly (in low-risk patients with adequate monitoring after administration) the incidence of adverse fetal outcomes during the at-home portion of cervical ripening is likely to be very low. With responsible use, outpatient administration of prostaglandins should be safe. Women are monitored after misoprostol administration and are not sent home if there are any concerns for fetal distress or if frequent contractions continue. Misoprostol reaches maximum blood concentration 30 minutes after oral administration and 70 to 80 minutes after vaginal administration.²⁸ After this time, if contractions start to intensify it is likely that misoprostol has triggered spontaneous labor. In this setting, women are routinely allowed to spontaneously labor at home. One may even argue that outpatient misoprostol could lead to improved safety, as women essentially have a contraction stress test prior to spontaneous labor, and misoprostol administration as an outpatient, as opposed to as an inpatient, may allow for longer time intervals between doses, which could prevent dose stacking.

Continue to: Our approach to pharmacologic cervical ripening...

Our approach to pharmacologic cervical ripening

Our hospital has been conducting outpatient cervical ripening using vaginal misoprostol for more than 15 years without any known adverse safety concerns (FIGURE 3). Women with a low-risk, singleton pregnancy between 39+0 and 40+6 weeks are potential candidates for outpatient ripening. The majority of outpatient inductions are done electively without any medical indication. Women with stable, minor risk factors (such as diet-controlled gestational diabetes) also may be candidates at their clinician’s discretion. Patients are monitored either in our L&D triage area or in our outpatient antenatal unit; both units are in the same building. One clinician offers outpatient misoprostol in the office, across the street from L&D. We allow for clinician flexibility after administration. Some clinicians do 1 or 2 doses of outpatient cervical ripening in a day prior to a scheduled inpatient induction the next day. Some do multiple daily doses over the course of a week.

Conclusion

While the data continue to be limited, we strongly believe there is sufficient quality evidence from a safety and efficacy perspective to support implementation and evaluation of outpatient cervical ripening protocols for low-risk pregnancies. In the setting of renewed commitments to reducing suboptimal health care costs and utilization as well as increasing patient satisfaction and control in their birthing experiences, we posit it is the responsibility of obstetricians, L&D leadership, and health care institutions to explore the implementation of outpatient cervical ripening for appropriate candidates in their settings.

Case 1 Induction at 39 weeks in a healthy nulliparous woman

A healthy 35-year-old woman (G1P0) at 39 weeks 0 days and with an uncomplicated pregnancy presents to your office for a routine prenatal visit. She inquires about scheduling an induction of labor, noting that she read a news story about induction at 39 weeks and that it might lower her chance of having a cesarean delivery (CD).

You perform a cervical exam—she is 1 cm dilated, 3 cm long, -2 station, posterior, and firm. You sweep her membranes after obtaining verbal consent. After describing the induction process, you explain that she might be hospitalized for several days before the birth given the need for cervical ripening. “You mean I need to stay in the hospital for the entire process?” she asks incredulously.
 

Over the past 20 years, the percentage of patients undergoing induction of labor (IOL) has increased from 10% to 25%.¹ This percentage likely will rise over time, particularly in the wake of a recent randomized controlled trial suggesting potential maternal benefits, such as reduced CD rate, for nulliparas induced at 39 weeks compared with expectant management.² Although there have not been any changes to guidelines for timing of IOL from such professional societies such as the American College of Obstetricians and Gynecologists (ACOG) or the Society for Maternal-Fetal Medicine, key considerations of rising IOL volume include patient experience, labor and delivery (L&D) units’ capacity and resources, and associated health care costs.

An essential part of successful induction involves patience. Induction can be a lengthy process, particularly for nulliparas with unripe cervices. Cervical ripening is a necessary component of successful labor induction, whether achieved mechanically or pharmacologically with synthetic prostaglandins, and it has been shown to lower the chance of CD.^3,4 However, achieving a ripe cervix is often the lengthiest part of an induction, and not uncommonly consumes 12 to 24 hours or more of inpatient time. Investigators have sought ways to make this process more expeditious. For example, the FOR-MOMI trial demonstrated that the induction-to-delivery time was several hours shorter when cervical ripening combined mechanical and pharmacologic approaches (Foley balloon plus misoprostol), compared with either method alone, without any increase in maternal or fetal complication rates.⁵

Better yet, what if admission to the L&D unit for IOL at term could be deferred until the cervix is ripe? A number of hospitals in the United States have successfully introduced outpatient cervical ripening, and several small observational and randomized controlled trials have reported good results in terms of safety, efficacy and time saved, and patient experience. Here, we will make the case that outpatient cervical ripening should be the standard of care for low-risk pregnancies.

Mechanical cervical ripening

Safety

Although data are limited on the safety, the authors of an ACOG Practice Bulletin suggest that, based on the available evidence of mechanical ripening in an inpatient setting, it is also appropriate in the outpatient setting.⁶ Unlike cervical ripening using prostaglandins, mechanical ripening is not associated with tachysystole, fetal intolerance of labor, or meconium staining.³ A cohort study of nearly 2,000 low-risk patients who underwent Foley catheter placement for cervical ripening using an outpatient protocol but monitored overnight as inpatients and evaluated for adverse outcomes found no CD for fetal distress, vaginal bleeding, placental abruption, or intrapartum stillbirth.⁷ The authors posited that, given this safety profile in the inpatient setting, that mechanical cervical ripening with a Foley catheter would be appropriate for outpatient use in low-risk populations. Other systematic reviews have been reassuring as well, with exceedingly low complication rates during inpatient mechanical cervical ripening.⁸ These data advocate for the evaluation of cervical ripening in the outpatient setting.

The evidence for outpatient mechanical ripening, although again limited, also has demonstrated safety. There does not appear to be an increased rate of maternal or neonatal complications, including infectious morbidity, postpartum hemorrhage, CD, operative vaginal delivery, or fetal distress.^9-12

Continue to: Efficacy and length-of-stay...

Efficacy and length-of-stay

Efficacy also generally has been shown to be similar when mechanical methods are used in the inpatient and outpatient settings. Small randomized trials of outpatient versus inpatient Foley catheter ripening have shown decreased length of stay (by 10 to 13 hours) and similar or less oxytocin use in the outpatient groups, as well as similar Bishop scores after cervical ripening and no difference in maternal or fetal outcomes.^9,11,13,14

One major concern with increasing IOL prevalence is the availability of hospital resources and the associated health care costs, given the known increased length of inpatient stay due to cervical ripening time. Admission to an L&D unit is resource intensive; the costs are similar to admission to an intensive care unit in many hospitals given its level of acuity and high nurse/patient ratio. However, given the safety of outpatient mechanical cervical ripening described above, we argue that routinely admitting low-risk patients for mechanical ripening constitutes a suboptimal use of costly resources.

Indeed, data suggest significant inpatient time savings if cervical ripening can be accomplished prior to admission. A cost-effectiveness analysis in the Netherlands demonstrated a nearly 1,000-euro decrease in cost per induction when Foley catheter induction was done on an outpatient basis.¹⁵ Interestingly, a recent trial confined to multiparas found no differences in hospital time when comparing outpatient ripening with Foley balloon alone with inpatient ripening with Foley balloon plus simultaneous oxytocin.¹⁰ This certainly merits further study, but it may be that the largest time- and cost-savings are among nulliparas.

Patient preferences

Relatively few studies specifically have addressed patient experiences with outpatient versus inpatient mechanical cervical ripening. Outpatient cervical ripening may provide patients with the benefits of being in the comfort of their own homes with their preferred support persons, increased mobility, more bodily autonomy, and satisfaction with their birthing process.

In a pilot trial involving 48 women, inpatient was compared with outpatient cervical ripening using a Foley balloon. Those in the outpatient group reported getting more rest, feeling less isolated, and having enough privacy. However, participants in both groups were equally satisfied and equally likely to recommend their method of induction to others.¹¹ Another study comparing outpatient versus inpatient Foley balloon cervical ripening found that 85% of patients who underwent outpatient ripening were satisfied with the induction method; however, no query or comparison was done with the inpatient group.¹² A trial comparing outpatient mechanical cervical ripening with inpatient misoprostol found that outpatient participants reported several hours more sleep and less pain.¹⁶ And in a discrete choice experiment of British gravidas, participants favored the option of outpatient cervical ripening, even if it meant an extra 1.4 trips to the hospital and over an hour of extra travel time.¹⁷

While these preliminary findings provide some insight that patients may prefer an outpatient approach to cervical ripening, more studies are needed to fully evaluate patient desires.

Continue to: Our approach to mechanical cervical ripening...

Our approach to mechanical cervical ripening

Most patients undergoing scheduled IOL are reasonable candidates for outpatient cervical ripening based on safety and efficacy. By definition, scheduling in advance implies that the provider has determined that outpatient management is reasonable until that date, and the plan for outpatient ripening need not prolong this period.

FIGURES 1 and 2 show protocols for our 2 hospital centers, which regularly allow for outpatient mechanical cervical ripening. In the process of protocol development, we identified absolute and relative contraindications to determine appropriate candidates. We exclude women who require inpatient management of medical or obstetric conditions (for example, women with severe preeclampsia or any condition requiring continuous fetal monitoring). We also do not routinely recommend outpatient cervical ripening to patients who do not have the necessary social conditions to make this process as safe as possible (including stable housing, reliable transportation, and a support person), although this occurs with some exceptions depending on individual patient situations.

Some examples of ideal candidates for outpatient mechanical cervical ripening include those undergoing elective or routine prolonged gestation inductions, or inductions for well-controlled, stable conditions (chronic hypertension and gestational diabetes). At one center, after thorough counseling and assessment, outpatient cervical ripening is also offered to patients with mild risk factors, including twins, prior low transverse CD, stable preeclampsia without severe features, isolated oligohydramnios with otherwise reassuring fetal status, and other similar conditions.

After mechanical cervical ripening placement (either Foley catheter or mechanical dilators), the clinician completes a postprocedure safety checklist and detailed procedure documentation, including number and type of foreign bodies placed. If there are any concerns regarding maternal or fetal well-being, the patient is sent to L&D for evaluation. If the procedure was tolerated well, the patient is discharged home, after a reactive postprocedure nonstress test is done, with detailed instructions for self-care, as well as with a list of symptoms that warrant prompt evaluation prior to scheduled induction time. In a large California hospital group following a similar protocol, only about 5% of women presented in labor before their scheduled induction.¹⁸

Case 2 Cervical ripening for labor preparation in low-risk pregnancy

A 32-year-old woman (G1P0) with an uncomplicated pregnancy at 40 weeks and 3 days presents to your office for a routine prenatal visit. Her vital signs are normal, and her fetus is vertex with an estimated fetal weight of 7.5 lb by Leopald’s maneuvers. You perform a cervical exam and find that her cervix is closed, long, and posterior.

You discuss with her your recommendation for induction of labor by 41 weeks, and she agrees. You also discuss the need for cervical ripening and recommend misoprostol given her closed cervix. You explain that several doses may be needed to get her cervix ready for labor, and she asks, “Do I have to stay in the hospital that whole time?”

Pharmacologic cervical ripening

Efficacy

There are multiple pharmacologic agents that can be used for ripening an unfavorable cervix. The main agents used in the United States are prostaglandins, either PGE1 (oral or vaginal misoprostol) or PGE2 in a gel or sustained-release vaginal insert (dinoprostone).

Outpatient misoprostol to avoid labor induction. Many studies have looked at outpatient misoprostol use as a “prophylactic measure” (to prevent the need for labor induction). For example, Gaffaney and colleagues showed that administering outpatient oral misoprostol (100 µg every 24 hours for up to 3 doses) after 40 weeks’ gestation to women with an unfavorable cervix significantly decreased the time to delivery by a day and a half.¹⁹ Similarly, PonMalar and colleagues demonstrated that administering 25 µg of vaginal misoprostol in a single dose as an outpatient after stripping the membranes significantly reduced time to delivery by 2 days.²⁰ And Stitely and colleagues found a significant reduction in the need for labor induction with the use of outpatient vaginal misoprostol. They administered up to 2 doses of misoprostol 25 µg vaginally every 24 hours for the 48 hours prior to a scheduled postdates induction and found a large reduction in the need for labor induction (11% vs 85%; P<.01).²¹

Continue to: Multiple protocols and regimens...

Multiple protocols and regimens have been studied but, overall, the findings suggest that administering outpatient misoprostol may shorten the time interval to spontaneous labor and decrease the need for a formal labor induction.^19-23

Inpatient compared with outpatient prostaglandin use. These trials of “prophylactic” misoprostol generally have compared outpatient administration of misoprostol with placebo. Prostaglandins are one of the most common methods of inpatient cervical ripening, so what about comparisons of inpatient cervical ripening with outpatient prostaglandin administration? There are a handful of studies that make this comparison.

Chang and colleagues looked retrospectively at inpatient and outpatient misoprostol and found that outpatient administration saved 3 to 5 hours on labor and delivery.²⁴ Biem and colleagues randomly assigned women to either inpatient cervical ripening with PGE2 intravaginal inserts or 1 hour of inpatient monitoring after PGE2 administration and then outpatient discharge until the onset of labor or for a nonstress test at 12 hours. They found that those who underwent outpatient ripening spent 8 hours less on labor and delivery and were more highly satisfied with the initial 12 hours of labor induction experience (56% vs 39%; P<.01).²⁵

The largest randomized controlled trial conducted to study outpatient prostaglandin use was the OPRA study (involving 827 women). Investigators compared inpatient to outpatient PGE2 intravaginal gel.²⁶ The primary outcome was total oxytocin administration, which was not different between groups. The study was underpowered, however, as 50% of women labored spontaneously postrandomization. But in the outpatient arm, less than half of the women required additional inpatient ripening, and nearly 40% returned in spontaneous labor, suggesting that outpatient prostaglandin administration may indeed save women a significant amount of time on labor and delivery.

Safety

The safety of outpatient administration of prostaglandins is the biggest concern, especially since, when prostaglandins are compared to outpatient Foley catheter use, Foleys are overall associated with less tachysystole, fetal intolerance, and meconium-stained fluid.³ Foley catheter use for cervical ripening may not be an appropriate choice for all patients, however. For instance, our case patient has a closed cervix, which could make Foley insertion uncomfortable or even impossible. Misoprostol use also offers the potential for flexibility in cervical ripening protocols as patients need not return for Foley balloon removal and indeed labor induction need not take place immediately after administration of misoprostol.

Patients also may prefer outpatient cervical ripening with misoprostol over a Foley. There are some data to suggest that women, overall, have a preference toward prostaglandins; in the PROBAAT-II trial, which compared inpatient oral misoprostol to Foley catheter for cervical ripening, 12% of women in the Foley arm would have preferred another method of induction (vs 6% in the misoprostol arm; P = .02).²⁷ This preference may be magnified in an outpatient setting.

But, again, is outpatient administration of prostaglandins safe? The published trials thus far have not reported an increase in out-of-hospital deliveries or adverse fetal outcomes. However, studies have been of limited size to see more rare outcomes. Unfortunately, an adequately powered study to demonstrate safety is likely never to be accomplished, given that if used responsibly (in low-risk patients with adequate monitoring after administration) the incidence of adverse fetal outcomes during the at-home portion of cervical ripening is likely to be very low. With responsible use, outpatient administration of prostaglandins should be safe. Women are monitored after misoprostol administration and are not sent home if there are any concerns for fetal distress or if frequent contractions continue. Misoprostol reaches maximum blood concentration 30 minutes after oral administration and 70 to 80 minutes after vaginal administration.²⁸ After this time, if contractions start to intensify it is likely that misoprostol has triggered spontaneous labor. In this setting, women are routinely allowed to spontaneously labor at home. One may even argue that outpatient misoprostol could lead to improved safety, as women essentially have a contraction stress test prior to spontaneous labor, and misoprostol administration as an outpatient, as opposed to as an inpatient, may allow for longer time intervals between doses, which could prevent dose stacking.

Continue to: Our approach to pharmacologic cervical ripening...

Our approach to pharmacologic cervical ripening

Our hospital has been conducting outpatient cervical ripening using vaginal misoprostol for more than 15 years without any known adverse safety concerns (FIGURE 3). Women with a low-risk, singleton pregnancy between 39+0 and 40+6 weeks are potential candidates for outpatient ripening. The majority of outpatient inductions are done electively without any medical indication. Women with stable, minor risk factors (such as diet-controlled gestational diabetes) also may be candidates at their clinician’s discretion. Patients are monitored either in our L&D triage area or in our outpatient antenatal unit; both units are in the same building. One clinician offers outpatient misoprostol in the office, across the street from L&D. We allow for clinician flexibility after administration. Some clinicians do 1 or 2 doses of outpatient cervical ripening in a day prior to a scheduled inpatient induction the next day. Some do multiple daily doses over the course of a week.

Conclusion

While the data continue to be limited, we strongly believe there is sufficient quality evidence from a safety and efficacy perspective to support implementation and evaluation of outpatient cervical ripening protocols for low-risk pregnancies. In the setting of renewed commitments to reducing suboptimal health care costs and utilization as well as increasing patient satisfaction and control in their birthing experiences, we posit it is the responsibility of obstetricians, L&D leadership, and health care institutions to explore the implementation of outpatient cervical ripening for appropriate candidates in their settings.