Journal of Midwifery & Women’s Health
www.jmwh.org
Original Research
The Development of a Consensus Statement on Normal Physiologic Birth: A Modified Delphi Study Holly Powell Kennedy, CNM, PhD, Melissa Cheyney, PhD, CPM, LDM, Mary Lawlor, CPM, LM, NHCM, MA, Suzy Myers, LM, CPM, MPH, Kerri Schuiling, CNM, PhD, Tanya Tanner, CNM, MS, MBA, and the Normal Birth Task Force of the American College of Nurse-Midwives, the Midwives Alliance of North America, and the National Association of Certified Professional Midwives
Introduction: This article describes the process of developing consensus on a definition of, and best practices for, normal physiologic birth in the United States. Evidence supports the use of physiologic birth practices, yet a working definition of this term has been elusive. Methods: We began by convening a task force of 21 individuals from 3 midwifery organizations and various childbirth advocacy and consumer groups. A modified Delphi approach was utilized to achieve consensus around 2 research questions: 1) What is normal physiologic birth? and 2) What practices most effectively support its achievement? Answers to these questions were collected anonymously from task force members during multiple phases that included a preliminary briefing, an initial face-to-face roundtable, 9 iterative Delphi rounds, and reciprocal feedback from a wider audience of stakeholders at national and international conferences. Content analysis identified specific statements and concepts in the first Delphi round, which were subsequently ranked in following rounds. An initial draft was constructed based on the priorities that emerged and presented for feedback to peers and childbirth advocates whose comments were incorporated into the final document. Results: Four key themes were identified from our initial questions; these provided the framework for the document: 1) definitions of normal physiologic birth, 2) mechanisms and outcomes of normal physiologic birth, 3) factors that influence normal physiologic birth, and 4) recommendations for increasing normal physiologic birth. These areas comprised the final sections in the multi-organizational consensus statement. Discussion: The modified Delphi approach we employed allowed for the development of a consensus statement that will serve as a template for education, practice, and future research in maternity care. The completion of this statement marks the beginning of a project to promote systemic changes that support normal physiologic birth, and thus, have the potential to improve outcomes for mothers and infants. c 2015 by the American College of Nurse-Midwives. J Midwifery Womens Health 2015;60:140–145 Keywords: childbirth, consensus, evidence-based practice, Delphi technique, midwifery, policy, task force
INTRODUCTION
One in 3 first-time mothers in the United States give birth by cesarean,1,2 and the rate of cesarean birth when labor is induced is twice that reported for spontaneous labor.2 This high rate is due to 2 trends: a decrease in the number of vaginal births after cesarean (VBACs) and an increase in the number of primary cesareans, which includes a sharp rise in women receiving a cesarean for no indicated risk—6.9% of all women and 11.2% of all first-time mothers.3 In addition, even though approximately half of all women in the United States will use epidural analgesia,4 studies show that second-stage cesareans are often performed well before the recommended time guidelines proposed by the American College of Obstetricians and Gynecologists.2,5 Too few women, especially firsttime mothers, experience spontaneous labors and births in the United States.6 Why does spontaneous labor matter? We have laborinducing drugs; why not use them to bring about labor at a time that may be more convenient for the woman, her family, and her care team? This is not an especially new debate, but it is one that is taking on greater significance as we face concerns related to the risks of multiple cesareans, placental abnormalities, hemorrhage, and for some, hysterectomy Address correspondence to Melissa Cheyney, Department of Anthropology, Oregon State University, Waldo Hall 238, Corvallis, OR 97331. E-mail: [email protected]
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or even death.7 Neonates born by elective or repeat cesarean may have increased rates of respiratory problems compared to those born vaginally.8,9 Furthermore, emerging evidence demonstrates that intrapartum care may have epigenetic and long-term health consequences for the child.10,11 Although cesarean birth can be indicated and lifesaving, the World Health Organization has asserted that a 15% rate is appropriate for most populations.12 Studies suggest that many US maternity care providers widely overuse interventions that have minimal beneficial effects for mother or fetus, while simultaneously underusing those known to be helpful.13 Evidence-based practices for increasing primary vaginal birth have been referred to as “Mother-Friendly Care” and include: 1) unrestricted access to birth companions of the woman’s choice, continuous emotional and physical support from a skilled woman, and access to midwife-led care; 2) freedom to walk, move about and assume positions of choice during labor and birth, and discouragement of the lithotomy position; and 3) non pharmacologic methods of pain relief such as massage, hypnosis, and hydrotherapy.14,15 Yet women are not routinely provided these options in US hospitals, and many report experiences that reflect a trend toward increased intervention in childbirth.16 Other countries have begun to examine how to influence excessive childbirth intervention rates by proposing statements that describe “normal birth.”17–21 Yet, our review c 2015 by the American College of Nurse-Midwives
✦ Other nations have developed statements that describe normal, physiologic birth; however, the United States lacked a similar document until recently. ✦ A task force of 21 individuals from 3 US midwifery organizations and select members from childbirth advocacy and consumer groups reached consensus on a definition for normal physiologic birth and the practices that best support its achievement. ✦ This resulted in a document: “Supporting Healthy and Normal Physiologic Childbirth: A Consensus Statement by the American College of Nurse-Midwives, Midwives Alliance of North America, and the National Association of Certified Professional Midwives.” ✦ The consensus document developed by this task force provides the foundation for a toolkit that can be used to help promote normal physiologic birth, improve outcomes for women and newborns, and reduce unnecessary and costly interventions. of these statements found them inconsistent, especially about what constitutes appropriate support for the normal physiologic processes of labor and birth in women who are low risk, as well as in what constitutes a reasonable or beneficial intervention. These statements offer only minimal discussion of women’s and infants’ physiology and provide incomplete evidence for how to best support optimal functioning throughout labor and birth. The United States, until the initiation of the project described here, lacked a similar document. Thus, our purpose was to develop a consensus statement, using a modified Delphi method that would: 1) provide a succinct definition of normal physiologic birth; 2) identify measurable benchmarks to describe optimal processes and outcomes reflective of normal physiologic birth; 3) identify factors that facilitate or disrupt normal physiologic birth based on the best available evidence; 4) provide a template for system changes in clinical practice, education, research, and health policy; and ultimately, 5) improve the health of women and newborns, while avoiding unnecessary and costly interventions. The resulting statement was published in 2012.22 The purpose of this article is to describe the methods used to develop and reach consensus on the final statement. METHODS Design
The original Delphi method was developed by the RAND Corporation to assist groups with varying levels of expertise and power among members to grapple with difficult decisions.23,24 Today, Delphi methodology is commonly used to create formal consensus statements and has also been used to describe exemplary midwifery practice.25 The process is initiated by gathering experts to act as panelists to address a problem or common issue. Then, an anonymous and iterative process begins with a first round of open-ended questions producing qualitative data to be content analyzed, resulting in specific statements about the issue. Additional rounds to rank or prioritize the resulting statements continue until there is movement toward consensus for each statement. Anonymity permits those with less power to have their opinions given equal weight. The guiding research questions for this modified Delphi study were: 1) What is normal physiologic birth? and 2) What practices best support its achievement? Journal of Midwifery & Women’s Health r www.jmwh.org
Sample
A group representing 3 US midwifery organizations — the American College of Nurse-Midwives (ACNM), the Midwives Alliance of North America (MANA), and the National Association of Certified Professional Midwives (NACPM) — was invited to serve as the expert panel. The leadership of ACNM invited MANA and NACPM to collaborate on this project based on 2 clearly defined needs. First, ACNM acknowledged the practical need for a statement on normal physiologic birth and recognized that midwives were uniquely suited to develop it because of our shared expertise and knowledge.26–28 Second, the project provided an opportunity to unite the 3 primary US midwifery organizations around a common purpose. After agreeing to participate in the project, each organization nominated potential panelists who were then contacted and invited to join a task force. Additional members representing childbirth advocacy and consumer groups were added to provide their unique perspective on physiologic birth, resulting in a total of 21 task force members. One ACNM member was also able to articulate the viewpoints of a national birth trauma group. We considered expanding the panel to groups representing physicians in birth care. However, because a major focus of midwifery care is on caring for childbearing women of low risk, we decided to keep the group more focused to that expertise. The panel convened in May 2010 and worked closely together for 2 years on the study. The study received ethics approval from Northern Michigan University’s investigational review board, and all panelists provided written informed consent to participate.
Procedure
We used a modified Delphi approach to enhance the process.29,30 Prior to beginning the process, we scheduled a face-to-face meeting, believing it was crucial for panelists to have the opportunity to discuss and reach agreement on the methods, procedures, and first-round survey questions. Prior to this gathering, all panel members were offered the opportunity to act as expert participants and provided with written information about the study. The critical component of anonymity was preserved after the initial meeting as we moved through each round and up until a consensus 141
document was drafted. Also important to this Delphi study was the use of a research jury to provide guidance to the researchers and to assist with data interpretation.31 A small working group representing the 3 midwifery organizations was appointed to act as the research jury. The first 2 Delphi rounds proceeded according to common Delphi methodology with a focus on achieving consensus on specific statements related to normal physiologic birth.23,24 Round I asked broad open-ended questions about birth and birth care developed by the panelists from their reviews of the literature and the statements produced by other countries.17–21 Table 1 provides Round I questions posed to the panelists. The responses to Round I produced qualitative data that were entered into Atlas.ti (ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), a software program designed to help organize and manage text-based analysis. Preliminary analyses were conducted by 2 members of the team (first and last authors) and reviewed by the research jury. We used content analysis to examine the responses to Round I using both a pre arranged set of codes derived from the questions (deductive) and multiple new codes identified from the responses (inductive). These codes were collapsed into broad categories and statements were developed using the language of the panelists when possible. These statements comprised Round II and formed the basis for the rest of the iterative rounds to rank their importance and achieve consensus on their inclusion in the final statement on normal physiologic birth. Examples of statements to be ranked included:
prioritization by the entire panel. Subsequent rounds revised these statements based on input from the panelists, who were also asked to provide current evidence to support the statements. As the consensus document drafts were developed, we sought feedback at several national and international midwifery conferences. After formal podium presentations, we invited commentary from the audience at the 2011 Annual Meetings of ACNM and MANA and the 2011 Triennial Congress of the International Confederation of Midwives held in South Africa. This step, representing a modification of Delphi methodology, prompted exceptionally robust discussions about the key components of the statement, areas of potential misunderstanding, and commentary on the international and cultural relevance of the document. Major discussion points included debate about the use of the word normal versus physiologic, healthy, safe, or optimal; and debate about birth environment, purpose of the document, and elimination of jargon language. These comments were evaluated by the panel during Rounds IV through IX, and, where consensus was achieved, they were inserted into the statement. At this point a draft version was sent for external review to various childbirth stakeholder groups, including Childbirth Connection, Lamaze International, and the ACNM, MANA, NACPM boards of directors. Their feedback was incorporated and agreed to by the expert panel in April 2011. The boards of directors of all 3 US midwifery organizations approved the final consensus statement in May 2012.
The following should be INCLUDED in the joint position statement:
OUTCOMES
Spontaneous labor/birth Nourishment Skin-to-skin The following should be EXCLUDED in the joint position statement: Limited movement/positions IVs Internal/continuous monitoring The Vovici online platform (Verint, Melville, NY) was used to manage data collection. Statements were retained if 75% of the panelists scored it at 4 out of 6 or higher in Round II. The entire Delphi survey can be viewed online (See Supporting Information: Appendix S1). Most Delphi studies achieve consensus in 2 to 3 rounds, but more may be necessary in the event that consensus cannot be reached within early rounds; ours required 9.32 We interpret the need for a higher than average number of rounds as a reflection of the complexity of developing a consensus statement on normal physiologic birth and the ways it can be supported in clinical practice. Each round required panelists to respond to the emerging framework of the document. Seven additional iterative Delphi rounds (beyond the initial 2) were conducted as the research jury categorized the retained statements across major content areas and then organized those into a working format that became the essential architecture of the statement. The mean ranking of each statement in the document was placed next to it so the panelists could view its 142
The complete statement was published in its entirety in the Journal of Midwifery & Women’s Health.22 Our key findings are described in this article in the order they were incorporated into the final statement. Preamble
The panelists believed it was essential to begin the statement with a summary of its purpose and context. The purpose of the study was to identify the key components of, and supports for, normal physiologic birth as perceived by a sample of US organizations and providers supportive of (or skilled in providing) this type of care. The panelists consistently described the context and need for the statement as the increasing use of interventions in childbirth, even for women who are low risk — a pattern that was seen as highly problematic and not evidence-based. Defining the Normal Physiology of Childbirth
A major goal was to provide a definition of normal physiologic childbirth that was grounded in evidence. As might be expected, achieving consensus on this definition was one of the most challenging aspects of the study. The word normal was viewed as problematic, yet essential for many of the panelists. Some struggled with the use of the term normal, seeing it as dichotomous and carrying with it implications for abnormal. Are women who require exogenous oxytocin augmentation then abnormal? The implication of such labeling was unacceptable to many; however, there was an Volume 60, No. 2, March/April 2015
Table 1. First Round Delphi Open-ended Questions
What does normal mean to you as it pertains to childbearing? Do you think there is a better term to use than normal as it pertains to childbirth? If yes: You indicated that you think there is a better term than normal as it pertains to childbirth. Please provide the term and describe why. What aspects of the childbirth experience are associated with a normal birth? How does the environment influence normal birth? Please provide an example in your response. How does the provider of childbearing care influence a woman’s ability to have a normal birth? Please provide an example in your response. How does the woman influence her ability to have a normal birth? Please provide an example in your response. What care processes are associated with normal birth? What outcomes are associated with a normal birth? What criteria must be included to qualify as a normal birth? What criteria exclude a birth from qualifying as normal? What title would you suggest for this position statement? List any other elements with rationale that you believe should be included in this position statement.
ever-present concern that without the word normal, there could be no essential benchmark for measurement. Eventually, the panelists decided to focus on the physiology of birth as opposed to a birth outcome, thus providing a clearer context for the use of the term normal. The concept of normal was incorporated in to the final statement as an adjective used to modify physiology — that is, as a means of describing the usual, functional processes of an organism. We converged on the succinct definition: “A normal physiologic labor and birth is one that is powered by the innate human capacity of the woman and fetus.”22 This definition is embedded in and dependent upon evidence that suggests that when healthy women and fetuses are adequately supported and are left undisturbed, they usually experience normal physiologic functioning of labor and birth processes. These processes are also highly sensitive to disruption. In addition, panelists recognized that while some women and/or fetuses will need medical attention, supporting normal physiologic processes has the potential to enhance best outcomes for the woman and her newborn, even when complications are present.33–37
Factors That Influence Normal Physiologic Childbirth
The panelists identified 18 factors that influence the ability of a woman to experience a normal, physiologic birth. The woman’s individual health, knowledge and confidence, determination, access to skilled providers and environments supportive of physiologic birth (including midwives), and ability to participate in shared decision making about her care were described as essential and interrelated factors. Similarly, clinicians need to be knowledgeable and skilled in supporting physiologic birth, committed to shared decision making, and they require access to working environments that are supportive of normal, physiologic birth. The birth setting environment required that women are respected, have freedom of movement, access to nourishment, and time for decision making that is free from coercion. Fetal heart tones are intermittently auscultated and induction and/or augmentation are only used when there is a clinical indication. The factors are presented in the consensus statement in a way that provides measurable benchmarks for clinicians and institutions. Recommendations
Mechanisms and Outcomes of Normal Physiologic Birth
Absent from most other statements on normal birth was a discussion of maternal and fetal physiology and its relationship to outcomes. The panelists believed this was a critical gap, as such content would enable clinicians and policy makers to understand the link between care practices and outcomes. This portion of the statement presents current evidence on the neuroendocrine system and the release of endogenous oxytocin and beneficial catecholamines in response to stress, including childbirth.38,39 The highly sensitive and nuanced interplay of neurohormonal systems activated during parturition promotes effective labor, provides protective physiologic responses, and enhances bonding behavior between the woman and neonate.2,40–42 The statement proposes that optimal physiologic functioning decreases the likelihood of intervention or compromise, which in turn increases the likelihood of newborns getting the best possible start in life, both physically and emotionally. Journal of Midwifery & Women’s Health r www.jmwh.org
The statement ends with broad recommendations identified by the panelists as important for implementation and future study. This part of the process was comparatively straightforward with consensus achieved relatively quickly among the panelists. Recommendations were directed at: 1) changing hospital policies to support physiologic birth; 2) supporting the development of a more robust and widespread midwifery workforce; 3) better preparing inter disciplinary maternity health care clinicians for the application of care that promotes normal physiologic birth; and 4) developing a research agenda focused on the short-and long-term effects of normal physiologic birth. DISCUSSION
This modified Delphi study produced a comprehensive consensus statement on normal physiologic birth authored by 3 US midwifery organizations.22 As such, it accomplished the goal of providing a statement to serve as a template for 143
education, practice, and future research. Work on this statement also united the 3 midwifery organizations around a goal that required collective energy, discourse, and trust. This alone was a huge success. This statement marks an important opening of dialogue on the most effective strategies for slowing, and perhaps reversing, the trend toward routine interventions in childbirth for women who are low risk. However, this study and its end product have several limitations. First, the statement is about childbirth — a process that is unique to each woman, and yet, with the exception of the advocacy organizations that took part in the expert panel, a wide sample of women’s voices is absent. The panelists carefully considered this and believed that this phase of the work should focus on midwives’ perspectives on normal physiologic birth. Future work must include women’s perspectives and understandings of normal physiologic birth. Second, findings are limited in that the midwifery and childbirth advocacy communities were the primary data sources, reviewers, and synthesizers. Although one obstetrician conducted an informal review and provided commentary, we did not solicit input from a broad representation of clinicians; this will be important for future work. Currently, ACNM, with representatives from MANA and NACPM, has developed a consumer companion statement43 and is developing a toolkit that will be available for clinicians and institutions, as well as strategies for using the statement to influence childbirth policy on local and national levels. In particular, maternity care researchers and health economists have questioned how this work might provide a broader foundation for critically examining maternity care in the United States. As this work continues, we anticipate that the statement will be used in its current form by clinicians and institutions committed to examining their policies and practices around normal physiologic birth. We are also hopeful that it will play a vital role in the development of research agendas designed to more discretely examine the relationships between birth setting, care practices, and optimal, normal physiologic functioning during childbirth. CONCLUSION
The Supporting Healthy and Normal Physiologic Childbirth statement22 was developed using a rigorous, modified Delphi methodology with multiple survey rounds that allowed participants to reach consensus. This process has resulted in: 1) a succinct definition of normal physiologic birth; 2) the identification of measurable benchmarks to describe optimal processes and outcomes reflective of normal physiologic birth; 3) a description of key factors that facilitate or disrupt normal physiologic birth based on the best available evidence; and 4) perhaps most importantly, recommendations for system changes in clinical practice, education, research, and health policy that, together, have the capacity to improve the health of women and newborns through the avoidance of unnecessary and costly interventions. As maternity care in the United States becomes increasingly interventive, it is critical that clinicians and consumers have access to an evidence-based statement that defines and identifies key components of, and supports for, normal 144
physiologic birth. This statement represents a template for providing this care through the identification of specific factors that influence the ability to achieve normal physiologic birth for most women. These components must be clearly and accessibly articulated if there is any hope of them being incorporated into the US maternity care system. Future research should compare health outcomes and costs for institutions that successfully integrate these components with those that do not. Created by members of ACNM, MANA, and NACPM and endorsed by all 3 organizations, this statement heralds the tipping point in US maternity care toward fewer unnecessary and non-evidence-based interventions in birth. AUTHORS
Holly Powell Kennedy, PhD, FACNM, FAAN, is the Helen Varney Professor at Yale University and was the President of the American College of Nurse-Midwives at the time of this study. Melissa Cheyney, PhD, CPM, LDM, is an Associate Professor of medical anthropology in the Department of Anthropology at Oregon State University in Corvallis, OR. She is also a Certified Professional Midwife, licensed in the State of Oregon, and the Chair of the Midwives Alliance Division of Research. Mary Lawlor, CPM, LM, NHCM, MA, is the Executive Director of the National Association of Certified Professional Midwives. Suzy Myers, MPH, CPM, LM, is the Chair of the Department of Midwifery at Bastyr University in Kenmore, Washington. Kerri D. Schuiling, CNM, PhD, FACNM, FAAN, is professor and dean of the School of Nursing at Oakland University in Rochester, Michigan. In addition she is the Sr. Staff Researcher for ACNM, chair of the Research Standing Committee of the International Confederation of Midwives and co-editor of the International Journal of Childbirth. Tanya Tanner, CNM, PhD, MBA, is a course coordinator in the Community-based Nurse-Midwifery Program at Frontier Nursing University. She is also in clinical nurse-midwifery practice at the Medical Center of Aurora in Aurora, CO and is the treasurer of the American College of Nurse-Midwives. CONFLICT OF INTEREST
The authors have no conflicts of interest to disclose. ACKNOWLEDGEMENTS
The American College of Nurse-Midwives (8403 Colesville Road, Suite 1550, Silver Spring, MD 20910), Midwives Alliance of North America (MANA World Headquarters, 1500 Sunday Drive, Suite 102 Raleigh, NC 27607), and the National Association of Certified Professional Midwives (243 Banning Road, Putney VT 05346) supported this study. SUPPORTING INFORMATION
Additional Supporting Information may be found in the online version of this article at the publisher’s Web site: Appendix S1. The Normal Birth Delphi Survey Volume 60, No. 2, March/April 2015
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Original Research
The Development of a Consensus Statement on Normal Physiologic Birth: A Modified Delphi Study Holly Powell Kennedy, CNM, PhD, Melissa Cheyney, PhD, CPM, LDM, Mary Lawlor, CPM, LM, NHCM, MA, Suzy Myers, LM, CPM, MPH, Kerri Schuiling, CNM, PhD, Tanya Tanner, CNM, MS, MBA, and the Normal Birth Task Force of the American College of Nurse-Midwives, the Midwives Alliance of North America, and the National Association of Certified Professional Midwives
Introduction: This article describes the process of developing consensus on a definition of, and best practices for, normal physiologic birth in the United States. Evidence supports the use of physiologic birth practices, yet a working definition of this term has been elusive. Methods: We began by convening a task force of 21 individuals from 3 midwifery organizations and various childbirth advocacy and consumer groups. A modified Delphi approach was utilized to achieve consensus around 2 research questions: 1) What is normal physiologic birth? and 2) What practices most effectively support its achievement? Answers to these questions were collected anonymously from task force members during multiple phases that included a preliminary briefing, an initial face-to-face roundtable, 9 iterative Delphi rounds, and reciprocal feedback from a wider audience of stakeholders at national and international conferences. Content analysis identified specific statements and concepts in the first Delphi round, which were subsequently ranked in following rounds. An initial draft was constructed based on the priorities that emerged and presented for feedback to peers and childbirth advocates whose comments were incorporated into the final document. Results: Four key themes were identified from our initial questions; these provided the framework for the document: 1) definitions of normal physiologic birth, 2) mechanisms and outcomes of normal physiologic birth, 3) factors that influence normal physiologic birth, and 4) recommendations for increasing normal physiologic birth. These areas comprised the final sections in the multi-organizational consensus statement. Discussion: The modified Delphi approach we employed allowed for the development of a consensus statement that will serve as a template for education, practice, and future research in maternity care. The completion of this statement marks the beginning of a project to promote systemic changes that support normal physiologic birth, and thus, have the potential to improve outcomes for mothers and infants. c 2015 by the American College of Nurse-Midwives. J Midwifery Womens Health 2015;60:140–145 Keywords: childbirth, consensus, evidence-based practice, Delphi technique, midwifery, policy, task force
INTRODUCTION
One in 3 first-time mothers in the United States give birth by cesarean,1,2 and the rate of cesarean birth when labor is induced is twice that reported for spontaneous labor.2 This high rate is due to 2 trends: a decrease in the number of vaginal births after cesarean (VBACs) and an increase in the number of primary cesareans, which includes a sharp rise in women receiving a cesarean for no indicated risk—6.9% of all women and 11.2% of all first-time mothers.3 In addition, even though approximately half of all women in the United States will use epidural analgesia,4 studies show that second-stage cesareans are often performed well before the recommended time guidelines proposed by the American College of Obstetricians and Gynecologists.2,5 Too few women, especially firsttime mothers, experience spontaneous labors and births in the United States.6 Why does spontaneous labor matter? We have laborinducing drugs; why not use them to bring about labor at a time that may be more convenient for the woman, her family, and her care team? This is not an especially new debate, but it is one that is taking on greater significance as we face concerns related to the risks of multiple cesareans, placental abnormalities, hemorrhage, and for some, hysterectomy Address correspondence to Melissa Cheyney, Department of Anthropology, Oregon State University, Waldo Hall 238, Corvallis, OR 97331. E-mail: [email protected]
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or even death.7 Neonates born by elective or repeat cesarean may have increased rates of respiratory problems compared to those born vaginally.8,9 Furthermore, emerging evidence demonstrates that intrapartum care may have epigenetic and long-term health consequences for the child.10,11 Although cesarean birth can be indicated and lifesaving, the World Health Organization has asserted that a 15% rate is appropriate for most populations.12 Studies suggest that many US maternity care providers widely overuse interventions that have minimal beneficial effects for mother or fetus, while simultaneously underusing those known to be helpful.13 Evidence-based practices for increasing primary vaginal birth have been referred to as “Mother-Friendly Care” and include: 1) unrestricted access to birth companions of the woman’s choice, continuous emotional and physical support from a skilled woman, and access to midwife-led care; 2) freedom to walk, move about and assume positions of choice during labor and birth, and discouragement of the lithotomy position; and 3) non pharmacologic methods of pain relief such as massage, hypnosis, and hydrotherapy.14,15 Yet women are not routinely provided these options in US hospitals, and many report experiences that reflect a trend toward increased intervention in childbirth.16 Other countries have begun to examine how to influence excessive childbirth intervention rates by proposing statements that describe “normal birth.”17–21 Yet, our review c 2015 by the American College of Nurse-Midwives
✦ Other nations have developed statements that describe normal, physiologic birth; however, the United States lacked a similar document until recently. ✦ A task force of 21 individuals from 3 US midwifery organizations and select members from childbirth advocacy and consumer groups reached consensus on a definition for normal physiologic birth and the practices that best support its achievement. ✦ This resulted in a document: “Supporting Healthy and Normal Physiologic Childbirth: A Consensus Statement by the American College of Nurse-Midwives, Midwives Alliance of North America, and the National Association of Certified Professional Midwives.” ✦ The consensus document developed by this task force provides the foundation for a toolkit that can be used to help promote normal physiologic birth, improve outcomes for women and newborns, and reduce unnecessary and costly interventions. of these statements found them inconsistent, especially about what constitutes appropriate support for the normal physiologic processes of labor and birth in women who are low risk, as well as in what constitutes a reasonable or beneficial intervention. These statements offer only minimal discussion of women’s and infants’ physiology and provide incomplete evidence for how to best support optimal functioning throughout labor and birth. The United States, until the initiation of the project described here, lacked a similar document. Thus, our purpose was to develop a consensus statement, using a modified Delphi method that would: 1) provide a succinct definition of normal physiologic birth; 2) identify measurable benchmarks to describe optimal processes and outcomes reflective of normal physiologic birth; 3) identify factors that facilitate or disrupt normal physiologic birth based on the best available evidence; 4) provide a template for system changes in clinical practice, education, research, and health policy; and ultimately, 5) improve the health of women and newborns, while avoiding unnecessary and costly interventions. The resulting statement was published in 2012.22 The purpose of this article is to describe the methods used to develop and reach consensus on the final statement. METHODS Design
The original Delphi method was developed by the RAND Corporation to assist groups with varying levels of expertise and power among members to grapple with difficult decisions.23,24 Today, Delphi methodology is commonly used to create formal consensus statements and has also been used to describe exemplary midwifery practice.25 The process is initiated by gathering experts to act as panelists to address a problem or common issue. Then, an anonymous and iterative process begins with a first round of open-ended questions producing qualitative data to be content analyzed, resulting in specific statements about the issue. Additional rounds to rank or prioritize the resulting statements continue until there is movement toward consensus for each statement. Anonymity permits those with less power to have their opinions given equal weight. The guiding research questions for this modified Delphi study were: 1) What is normal physiologic birth? and 2) What practices best support its achievement? Journal of Midwifery & Women’s Health r www.jmwh.org
Sample
A group representing 3 US midwifery organizations — the American College of Nurse-Midwives (ACNM), the Midwives Alliance of North America (MANA), and the National Association of Certified Professional Midwives (NACPM) — was invited to serve as the expert panel. The leadership of ACNM invited MANA and NACPM to collaborate on this project based on 2 clearly defined needs. First, ACNM acknowledged the practical need for a statement on normal physiologic birth and recognized that midwives were uniquely suited to develop it because of our shared expertise and knowledge.26–28 Second, the project provided an opportunity to unite the 3 primary US midwifery organizations around a common purpose. After agreeing to participate in the project, each organization nominated potential panelists who were then contacted and invited to join a task force. Additional members representing childbirth advocacy and consumer groups were added to provide their unique perspective on physiologic birth, resulting in a total of 21 task force members. One ACNM member was also able to articulate the viewpoints of a national birth trauma group. We considered expanding the panel to groups representing physicians in birth care. However, because a major focus of midwifery care is on caring for childbearing women of low risk, we decided to keep the group more focused to that expertise. The panel convened in May 2010 and worked closely together for 2 years on the study. The study received ethics approval from Northern Michigan University’s investigational review board, and all panelists provided written informed consent to participate.
Procedure
We used a modified Delphi approach to enhance the process.29,30 Prior to beginning the process, we scheduled a face-to-face meeting, believing it was crucial for panelists to have the opportunity to discuss and reach agreement on the methods, procedures, and first-round survey questions. Prior to this gathering, all panel members were offered the opportunity to act as expert participants and provided with written information about the study. The critical component of anonymity was preserved after the initial meeting as we moved through each round and up until a consensus 141
document was drafted. Also important to this Delphi study was the use of a research jury to provide guidance to the researchers and to assist with data interpretation.31 A small working group representing the 3 midwifery organizations was appointed to act as the research jury. The first 2 Delphi rounds proceeded according to common Delphi methodology with a focus on achieving consensus on specific statements related to normal physiologic birth.23,24 Round I asked broad open-ended questions about birth and birth care developed by the panelists from their reviews of the literature and the statements produced by other countries.17–21 Table 1 provides Round I questions posed to the panelists. The responses to Round I produced qualitative data that were entered into Atlas.ti (ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), a software program designed to help organize and manage text-based analysis. Preliminary analyses were conducted by 2 members of the team (first and last authors) and reviewed by the research jury. We used content analysis to examine the responses to Round I using both a pre arranged set of codes derived from the questions (deductive) and multiple new codes identified from the responses (inductive). These codes were collapsed into broad categories and statements were developed using the language of the panelists when possible. These statements comprised Round II and formed the basis for the rest of the iterative rounds to rank their importance and achieve consensus on their inclusion in the final statement on normal physiologic birth. Examples of statements to be ranked included:
prioritization by the entire panel. Subsequent rounds revised these statements based on input from the panelists, who were also asked to provide current evidence to support the statements. As the consensus document drafts were developed, we sought feedback at several national and international midwifery conferences. After formal podium presentations, we invited commentary from the audience at the 2011 Annual Meetings of ACNM and MANA and the 2011 Triennial Congress of the International Confederation of Midwives held in South Africa. This step, representing a modification of Delphi methodology, prompted exceptionally robust discussions about the key components of the statement, areas of potential misunderstanding, and commentary on the international and cultural relevance of the document. Major discussion points included debate about the use of the word normal versus physiologic, healthy, safe, or optimal; and debate about birth environment, purpose of the document, and elimination of jargon language. These comments were evaluated by the panel during Rounds IV through IX, and, where consensus was achieved, they were inserted into the statement. At this point a draft version was sent for external review to various childbirth stakeholder groups, including Childbirth Connection, Lamaze International, and the ACNM, MANA, NACPM boards of directors. Their feedback was incorporated and agreed to by the expert panel in April 2011. The boards of directors of all 3 US midwifery organizations approved the final consensus statement in May 2012.
The following should be INCLUDED in the joint position statement:
OUTCOMES
Spontaneous labor/birth Nourishment Skin-to-skin The following should be EXCLUDED in the joint position statement: Limited movement/positions IVs Internal/continuous monitoring The Vovici online platform (Verint, Melville, NY) was used to manage data collection. Statements were retained if 75% of the panelists scored it at 4 out of 6 or higher in Round II. The entire Delphi survey can be viewed online (See Supporting Information: Appendix S1). Most Delphi studies achieve consensus in 2 to 3 rounds, but more may be necessary in the event that consensus cannot be reached within early rounds; ours required 9.32 We interpret the need for a higher than average number of rounds as a reflection of the complexity of developing a consensus statement on normal physiologic birth and the ways it can be supported in clinical practice. Each round required panelists to respond to the emerging framework of the document. Seven additional iterative Delphi rounds (beyond the initial 2) were conducted as the research jury categorized the retained statements across major content areas and then organized those into a working format that became the essential architecture of the statement. The mean ranking of each statement in the document was placed next to it so the panelists could view its 142
The complete statement was published in its entirety in the Journal of Midwifery & Women’s Health.22 Our key findings are described in this article in the order they were incorporated into the final statement. Preamble
The panelists believed it was essential to begin the statement with a summary of its purpose and context. The purpose of the study was to identify the key components of, and supports for, normal physiologic birth as perceived by a sample of US organizations and providers supportive of (or skilled in providing) this type of care. The panelists consistently described the context and need for the statement as the increasing use of interventions in childbirth, even for women who are low risk — a pattern that was seen as highly problematic and not evidence-based. Defining the Normal Physiology of Childbirth
A major goal was to provide a definition of normal physiologic childbirth that was grounded in evidence. As might be expected, achieving consensus on this definition was one of the most challenging aspects of the study. The word normal was viewed as problematic, yet essential for many of the panelists. Some struggled with the use of the term normal, seeing it as dichotomous and carrying with it implications for abnormal. Are women who require exogenous oxytocin augmentation then abnormal? The implication of such labeling was unacceptable to many; however, there was an Volume 60, No. 2, March/April 2015
Table 1. First Round Delphi Open-ended Questions
What does normal mean to you as it pertains to childbearing? Do you think there is a better term to use than normal as it pertains to childbirth? If yes: You indicated that you think there is a better term than normal as it pertains to childbirth. Please provide the term and describe why. What aspects of the childbirth experience are associated with a normal birth? How does the environment influence normal birth? Please provide an example in your response. How does the provider of childbearing care influence a woman’s ability to have a normal birth? Please provide an example in your response. How does the woman influence her ability to have a normal birth? Please provide an example in your response. What care processes are associated with normal birth? What outcomes are associated with a normal birth? What criteria must be included to qualify as a normal birth? What criteria exclude a birth from qualifying as normal? What title would you suggest for this position statement? List any other elements with rationale that you believe should be included in this position statement.
ever-present concern that without the word normal, there could be no essential benchmark for measurement. Eventually, the panelists decided to focus on the physiology of birth as opposed to a birth outcome, thus providing a clearer context for the use of the term normal. The concept of normal was incorporated in to the final statement as an adjective used to modify physiology — that is, as a means of describing the usual, functional processes of an organism. We converged on the succinct definition: “A normal physiologic labor and birth is one that is powered by the innate human capacity of the woman and fetus.”22 This definition is embedded in and dependent upon evidence that suggests that when healthy women and fetuses are adequately supported and are left undisturbed, they usually experience normal physiologic functioning of labor and birth processes. These processes are also highly sensitive to disruption. In addition, panelists recognized that while some women and/or fetuses will need medical attention, supporting normal physiologic processes has the potential to enhance best outcomes for the woman and her newborn, even when complications are present.33–37
Factors That Influence Normal Physiologic Childbirth
The panelists identified 18 factors that influence the ability of a woman to experience a normal, physiologic birth. The woman’s individual health, knowledge and confidence, determination, access to skilled providers and environments supportive of physiologic birth (including midwives), and ability to participate in shared decision making about her care were described as essential and interrelated factors. Similarly, clinicians need to be knowledgeable and skilled in supporting physiologic birth, committed to shared decision making, and they require access to working environments that are supportive of normal, physiologic birth. The birth setting environment required that women are respected, have freedom of movement, access to nourishment, and time for decision making that is free from coercion. Fetal heart tones are intermittently auscultated and induction and/or augmentation are only used when there is a clinical indication. The factors are presented in the consensus statement in a way that provides measurable benchmarks for clinicians and institutions. Recommendations
Mechanisms and Outcomes of Normal Physiologic Birth
Absent from most other statements on normal birth was a discussion of maternal and fetal physiology and its relationship to outcomes. The panelists believed this was a critical gap, as such content would enable clinicians and policy makers to understand the link between care practices and outcomes. This portion of the statement presents current evidence on the neuroendocrine system and the release of endogenous oxytocin and beneficial catecholamines in response to stress, including childbirth.38,39 The highly sensitive and nuanced interplay of neurohormonal systems activated during parturition promotes effective labor, provides protective physiologic responses, and enhances bonding behavior between the woman and neonate.2,40–42 The statement proposes that optimal physiologic functioning decreases the likelihood of intervention or compromise, which in turn increases the likelihood of newborns getting the best possible start in life, both physically and emotionally. Journal of Midwifery & Women’s Health r www.jmwh.org
The statement ends with broad recommendations identified by the panelists as important for implementation and future study. This part of the process was comparatively straightforward with consensus achieved relatively quickly among the panelists. Recommendations were directed at: 1) changing hospital policies to support physiologic birth; 2) supporting the development of a more robust and widespread midwifery workforce; 3) better preparing inter disciplinary maternity health care clinicians for the application of care that promotes normal physiologic birth; and 4) developing a research agenda focused on the short-and long-term effects of normal physiologic birth. DISCUSSION
This modified Delphi study produced a comprehensive consensus statement on normal physiologic birth authored by 3 US midwifery organizations.22 As such, it accomplished the goal of providing a statement to serve as a template for 143
education, practice, and future research. Work on this statement also united the 3 midwifery organizations around a goal that required collective energy, discourse, and trust. This alone was a huge success. This statement marks an important opening of dialogue on the most effective strategies for slowing, and perhaps reversing, the trend toward routine interventions in childbirth for women who are low risk. However, this study and its end product have several limitations. First, the statement is about childbirth — a process that is unique to each woman, and yet, with the exception of the advocacy organizations that took part in the expert panel, a wide sample of women’s voices is absent. The panelists carefully considered this and believed that this phase of the work should focus on midwives’ perspectives on normal physiologic birth. Future work must include women’s perspectives and understandings of normal physiologic birth. Second, findings are limited in that the midwifery and childbirth advocacy communities were the primary data sources, reviewers, and synthesizers. Although one obstetrician conducted an informal review and provided commentary, we did not solicit input from a broad representation of clinicians; this will be important for future work. Currently, ACNM, with representatives from MANA and NACPM, has developed a consumer companion statement43 and is developing a toolkit that will be available for clinicians and institutions, as well as strategies for using the statement to influence childbirth policy on local and national levels. In particular, maternity care researchers and health economists have questioned how this work might provide a broader foundation for critically examining maternity care in the United States. As this work continues, we anticipate that the statement will be used in its current form by clinicians and institutions committed to examining their policies and practices around normal physiologic birth. We are also hopeful that it will play a vital role in the development of research agendas designed to more discretely examine the relationships between birth setting, care practices, and optimal, normal physiologic functioning during childbirth. CONCLUSION
The Supporting Healthy and Normal Physiologic Childbirth statement22 was developed using a rigorous, modified Delphi methodology with multiple survey rounds that allowed participants to reach consensus. This process has resulted in: 1) a succinct definition of normal physiologic birth; 2) the identification of measurable benchmarks to describe optimal processes and outcomes reflective of normal physiologic birth; 3) a description of key factors that facilitate or disrupt normal physiologic birth based on the best available evidence; and 4) perhaps most importantly, recommendations for system changes in clinical practice, education, research, and health policy that, together, have the capacity to improve the health of women and newborns through the avoidance of unnecessary and costly interventions. As maternity care in the United States becomes increasingly interventive, it is critical that clinicians and consumers have access to an evidence-based statement that defines and identifies key components of, and supports for, normal 144
physiologic birth. This statement represents a template for providing this care through the identification of specific factors that influence the ability to achieve normal physiologic birth for most women. These components must be clearly and accessibly articulated if there is any hope of them being incorporated into the US maternity care system. Future research should compare health outcomes and costs for institutions that successfully integrate these components with those that do not. Created by members of ACNM, MANA, and NACPM and endorsed by all 3 organizations, this statement heralds the tipping point in US maternity care toward fewer unnecessary and non-evidence-based interventions in birth. AUTHORS
Holly Powell Kennedy, PhD, FACNM, FAAN, is the Helen Varney Professor at Yale University and was the President of the American College of Nurse-Midwives at the time of this study. Melissa Cheyney, PhD, CPM, LDM, is an Associate Professor of medical anthropology in the Department of Anthropology at Oregon State University in Corvallis, OR. She is also a Certified Professional Midwife, licensed in the State of Oregon, and the Chair of the Midwives Alliance Division of Research. Mary Lawlor, CPM, LM, NHCM, MA, is the Executive Director of the National Association of Certified Professional Midwives. Suzy Myers, MPH, CPM, LM, is the Chair of the Department of Midwifery at Bastyr University in Kenmore, Washington. Kerri D. Schuiling, CNM, PhD, FACNM, FAAN, is professor and dean of the School of Nursing at Oakland University in Rochester, Michigan. In addition she is the Sr. Staff Researcher for ACNM, chair of the Research Standing Committee of the International Confederation of Midwives and co-editor of the International Journal of Childbirth. Tanya Tanner, CNM, PhD, MBA, is a course coordinator in the Community-based Nurse-Midwifery Program at Frontier Nursing University. She is also in clinical nurse-midwifery practice at the Medical Center of Aurora in Aurora, CO and is the treasurer of the American College of Nurse-Midwives. CONFLICT OF INTEREST
The authors have no conflicts of interest to disclose. ACKNOWLEDGEMENTS
The American College of Nurse-Midwives (8403 Colesville Road, Suite 1550, Silver Spring, MD 20910), Midwives Alliance of North America (MANA World Headquarters, 1500 Sunday Drive, Suite 102 Raleigh, NC 27607), and the National Association of Certified Professional Midwives (243 Banning Road, Putney VT 05346) supported this study. SUPPORTING INFORMATION
Additional Supporting Information may be found in the online version of this article at the publisher’s Web site: Appendix S1. The Normal Birth Delphi Survey Volume 60, No. 2, March/April 2015
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