Topic link 4 ~ Essential Qualities of Maternity for Healthy Women +?+?+
Part III: Developing “Standard Characteristics” for OOH Studies of Intrapartum Care
Assumptions about OOH birth not fact-based on either side
Great confusion occurs when childbirth is extracted from the rest of life and looked at as outside the scheme of modern biological science. Women do not give birth in isolation from their culture, as if they were spinning around alone in outer space tethered to an oxygen tank. It is important to realistically evaluate the risks of childbirth in a healthy population in the context of both time and place.
It is no more appropriate to judge the safety of pregnancy and birth in isolation from modern science than any other aspect of our physical wellbeing, or stage of life – infancy, childhood, adolescence, a mature working person or old age. In the ‘bad old days’ before antibiotics and other marvels of modern medicine, just about every phase and every aspect of life could be dangerous, including but not exclusively childbirth. For example, in the early 1900s in the US, 1 out of five (20%) of children living in big city tenements died before reaching their fifth birthday. This is much larger number than the highest contemporary maternal mortality in the world, which is 1 out of 8 in Afghanistan. In our era of modern biological science, premature death has become rare in every aspect of life, including pregnancy, childbirth and early childhood. The safety net for is the same all people and places – appropriate use of preventative healthcare, modern medical treatment as needed and emergency services when indicated.
However, there are influential forces at both ends of this political spectrum that either deny or exaggerate the potential dangers associated with childbirth – both extremes lead to trouble and neither can be justified by the facts. The adverse effects and bad outcomes resulting from over treatment are not naturally better or worse than those from under treatment. Denying or seriously underestimating biological risk by some within the midwifery profession has already been addressed. The other end of this spectrum is exemplified by official policies and political actions of the American College of Obstetrics and Gynecologist over the last 3-plus decades.
The professional organization for obstetricians has publicly and formally rejected all peer-reviewed research to date on the relative safety of a professionally-attended OOH as a planned place of birth. ACOG continues to insist that the only way to satisfy their organization is randomized controlled trials (RCTs) conducted under the auspices of the obstetrical profession within the structure of a hospital review board. Between the vicarious liability for the institution and ethical and practical issue of randomizing place-of-birth, this idea can never be satisfactorily implemented.
Childbearing women are generally not willing to have the location of birth be randomly assigned. Only 11 of 77 women agreed to randomization in one attempt to conduct RCTs on place-of-birth. Even if there were a sufficient sample size it would be impossible to generalize from RCTs. Randomly assigning place-of-birth drastically changes the dynamics for the childbearing woman, since the most basic element of OOH birth is that the woman herself must voluntarily choose to have unmedicated labor and birth.
But in identifying RCTs as the only acceptable metric, ACOG seems to be choosing to perpetuate the historical controversy by locking out what we can know and identifying the impossible to obtain criteria (RCTs) as the only source of evidence that they will consider. ACOG position statements have also made it known that even if RCTs are conducted and support OOH care, they may well ignore the research and continue their exclusionary policies.
This position is remarkable in light of the historic relationship between obstetrical practice and evidence-based research, including RCTs. The current standard for normal childbirth in the US, which includes the “active management” of labor, is based on a strict obstetrical model that was originally adopted in 1910 and universally applied without first having conducted studies of any kind. In the intervening 10 decades, these unsupported assumptions having reevaluated.
Historical Context for Contemporary Obstetrical Policies
Most people assume that the way obstetrics is practiced today is the way it always was, but so-called ‘modern’ American obstetrics is a relatively resent invention. Through out the 19th century, obstetrics was always part of a non-specialty practice of medicine often referred to as ‘man-midwifery’. By 1910, this classic view of obstetrics as a hybrid form of midwifery practiced by GPs (who used physiologic management plus drugs for pain, forceps for prolonged labor, etc) was replaced by the ‘new obstetrics’ as a newly minted surgical specialty.
The new obstetrics was a whole new ball game. Obstetricians saw this drastic reshaping of childbirth as exciting modern solution to the ancient problem of unexpected, unexplainable complications seen so frequently in a pre-antibiotic era. Pregnancy was officially referred to as a “nine-month disease requiring a surgical cure”. At that time in history, a third of all maternal deaths in hospitalized maternity patients were the result of deadly infections — ‘childbed fever’ or puerperal sepsis — in the days following a normal birth.
An important obstetric textbook of the period flatly rejected the idea of childbirth as a normal or healthy function of female reproduction. Its author, Dr. Joseph DeLee, was a skilled and compassionate obstetrician with many admirable personal traits. He owned a small private lying-in hospital in inner city Chicago that served an immigrant population. He was known to provide care to the poorest of these women without charge. In his 1913 textbook he states that labor and birth, if viewed properly, are pathologic processes that damage both mothers and babies “often and much.” In the first issue of the American Journal of Obstetrics and Gynecology, Dr DeLee proposed a sequence of interventions designed to save women from the “evils natural to labor.”
No less a historical figure than Dr J. Whitridge Williams, chief of obstetrics at Johns Hopkins from 1911-1923, likewise believed there was no place for physiologic care (non-medicalized man-midwifery) in the modern practice of obstetrics: He said, “That word ‘physiological’ has all along stood as a barrier in the way of progress.”
This perspective gave us a pathology-oriented model of childbirth in which healthy women with normal pregnancies became the patients of a surgical specialty. Labor was seen as a pending emergency to be managed as a medicalized event by professional nurses; normal childbirth was to be conducted as a surgical procedure by an obstetrically-trained surgeon. The focus of health care during childbirth changed from “responding to problems as they arose to preventing problems”. [ref: Judith. Rooks] It was the obstetrician’s duty to control the course of labor and birth through the routine use of interventions, a policy that applied equally to those who were healthy and had normal pregnancies as it did to high-risk patients. These policies normalized the pre-emptive use of obstetrical intervention, made medicalized care the standard for labor and turned normal spontaneous birth into a surgical procedure.
This policy was directly responsible for the most profound change in childbirth practices in the history of the human species. It was implemented all across America without first having tested the fundamental hypothesis or its individual elements by conducting RCTs or any other form of scientific analysis that contrasted outcomes associated with strict obstetrical management in a healthy population to outcomes of physiologically-based model of care in a matching cohort.
No scientifically-conducted studies or statistical research was ever done that identified surgeons as the preferred choice for providing primary care for a healthy population or supported the routine use of obstetrical interventions and invasive procedures as a better model of maternity care. Nor was there any established scientific basis for re-assigning laboring women to a passive role, one that routinely rendered them unconscious under general anesthesia while the doctor delivered their baby, often assisted by episiotomy and forceps.
“In Johns Hopkins Hospital,” said Dr. Williams, “no patient is conscious when she is delivered of a child. She is oblivious under the influence of chloroform or ether. [Twilight Sleep: Simple Discoveries in Painless Childbirth, Dr. H. Smith Williams; 1914, p. 67]
It is just a fluke of history that a hundred years later we are still using the idea of normal birth as a surgical procedure, one that is still billed under a surgical code. This idea was originally introduced during a pre-antibiotic era (prior to 1937) in an effort to reduce the frequency of deadly childbirth-related infections, which were particularly risky for maternity patients giving birth in an institutional setting.
AUTHORITY-BASED MEDICINE: For two thousand years, the “art and science” of western medicine (a history traceable to Hippocrates in ancient Greece) was conducted as an authority-based discipline. No one had ever heard of ‘evidence-based’ medicine or ideas about applying rigorous research techniques to all aspects of health care prior to adopting them. Instead, advances in medical policies and practices were implemented on the direct authority of influential doctors and other leaders in the field who claimed to have a new or better idea. In a less technologically developed age, choices were often limited and drastic measures were simply accepted as the best choice among a host of lesser options.
EXPERIMENTAL MEDICINE: By today’s standards it seems irrational and unacceptable not to predicate important medical practices on strong scientific evidence, but this was normal until just 30 or so years ago. In 1976, the 2,000 year history of unchallenged authority of medical practitioners fell victim to its own excesses and simultaneously, to the inexorable momentum of modern science. In the wake of a scandal about 30 years of experimental research on syphilis done on a black population in Tuskegee, Alabama, President Carter appointed a federal Commission on Bioethics. This engendered a paradigm shift in thinking that is still re-shaping the dynamic field of healthcare.
This new perspective spurred the passage of federal laws that defined any new medical practice, drug or treatment for which safety and effectiveness had not yet been scientifically established, to be an ‘experimental’ practice of medicine. No longer was society willing give away its responsibility for its own well-being by blindly trusting doctors to always know what was best for their patients. For the first time, their were laws that required physicians and other practitioners to provide full disclosure and obtain the patient’s fully-informed and voluntary consent before the patient could receive unproven medical treatments or be enrolled in a clinical trial.
Unfortunately, these insights made no difference in childbirth practices. The 1910 configuration of obstetrics as a new surgical specialty for a healthy population — and all the interventions and invasive procedures associated with the obstetrical model of care — was never thought of as an experimental practice of medicine, not at the time and not since. So in 1976, no one thought to question the authority of the obstetrical profession to continue using an unproven interventionist model of obstetrics as the universal standard of care. By default, the ‘new obstetrics’ was grandfathered in to mainstream medicine by assuming that obstetrical policies and practices of intervention in normal childbirth had been put to the test and determined to be based on type 1 & 2 scientific evidence. That was not the case.
However, the classic principles and practices of physiologically-based care used routinely before 1910 — physical and psychological support, taking care not disturb the normal biological process, non-drug methods for coping with pain, an upright and mobile mother who moves around during labor and makes right use of gravity during second stage, the idea that it was the mother how gave birth under her own powers and that the proper role of the birth attendant was to assist and help her. Instead these non-medical activities, philosophies and supportive forms of care were no longer seen as time-tested ‘traditional’ ways, used successfully for millennia. In the post-1976 world, physiological management was now described as an unproven “alternative” method, the use of which was in violation of the new ideas of evidence-based medicine.
By not acknowledging these traditional methods to be a proven aspect of midwifery and instead re-labeling them as an unproven and experimental form of medicine, the principles of physiological care were easily dismissed by the obstetrical profession. This permitted the historical anti-physiological bias of the obstetrical profession to continue on as before and translated into an aggressive, even hostile rejection of physiologically-based care. These ideas and techniques were defined as having NO legitimate place in the practice of medicine. In recent years, ACOG has taunted consumer groups and the midwifery profession to ‘prove’ the legitimacy of each and every elements of physiologically-base care via by RCTs.
EVIDENCE-BASED MEDICINE — EXCEPT FOR ACOG: In the 34 years since the controversial issue of experimental medicine came to light, both the medical profession and society has recognized the value and embraced the benefits of evidence-based medicine. In spite of this, ACOG has still not reevaluated the historical assumptions about childbirth practices made during a pre-antibiotic era, even though these outdated ideas were implemented without being established as safe and cost-effective and continue to underpin contemporary care during normal childbirth in the US.
Nor has ACOG put policies in place that require RCTs to be conducted on all new obstetrical interventions before they are allowed to become standard practice. This is particularly relevant to the introduction of continuous electric fetal monitoring (EFM) in the 1970s and the current high-level of elective use of induction (33%) and operative delivery, which underpins our current 32% Cesarean rate. This highly interventive form of maternity care for a healthy population is an unproductive expensive that entails immediate, delayed and downstream risks of complications that affect a woman’s contemporary health, future childbearing ability and her wellbeing as she ages.
As an “expert” system, obstetrics has failed in the very area it was supposed to have the most mastery and expertise — preserving the health of already healthy mothers and babies.
Physicians Spokespersons for Medical Science
Physicians are the natural spokespersons for the scientific discipline of medicine. While that status bestows many privileges, it also comes with additional responsibilities. The very fact that Doctors of Medicine (MDs) are holders of a doctorate (equivalent of a PhD) in the science of medicine gives the public and the press every good reason to believe that formal statements made by physicians about matters of health, safety and medical care are unbiased, scientifically-based and factually correct.
This places a unique social burden of both candor and accuracy on doctors by virtue of their advanced education and license to practice medicine, with its legal power and elevated level of trust and respect. This results in a higher standard of ethical conduct for MDs than the mere recitation of personal preference or professional self-promotion. This high ethical standard would include a duty to communicate only scientifically valid information in a public forum unless such statements are identified as a personal, political or corporate opinion.
As amply demonstrated by the literature, many of those with a doctorate in medicine are not living up to their obligation to speak and act on the best scientific evidence. This has recently as been argued by state medical boards in regard to ‘expert witness testimony’ by MDs in disciplinary cases and other litigation that licensed physicians have a legal or “due diligence” obligation to provide “honest, complete, and impartial” information in their field of expertise. I suggest this would extent to the obstetrical profession in regard to press conferences and other public statements provided to the media.
Developing “Standard Characteristics” for OOH Studies
When it come to research on planned place-of-birth, RCTs are never going to be part of the picture, but that doesn’t mean that researchers are not interested in collecting data. Unfortunately, a number of high-profile studies on place-of-birth have been designed by those with no direct experience or interest in OOH birth. Some researchers apparently started out with a strong prejudice against OOH settings or equally strong desire to definitively prove the greater safety of highly medicalized care. Most media reports of OOH research do not distinguish between well-done studies with useful information and those that were poorly done and arrived at mistaken or misleading conclusions.
For example, a large retrospective study of planned home birth published in 2002 chose to use state birth certificate data from a state that did not collect or record the “intended” or planned place of birth. As a result, the study’s conclusion — that planning an OOH birth doubled the risk of neonatal death (a statement widely circulated by the media) was based on this unreliable data. A number of other studies that claim to prove hospital birth is safer or OOH more dangerous) have missing data, used poor methodology or other technical errors. This meant the study’s conclusions were not be supported by their own data.
Another example of this same problem is a recently published but much disputed OOH study — the Wax et al meta-analysis available on-line on July 2, 2010. Out of 16,500 birth that (may or may not) have been planned to occur OOH, the Wax analysis recorded a total of 32 neonatal death.” Twenty of these 32 deaths — nearly two-thirds — were taken from the 2002 study mention above that could not reliably determine whether an OOH birth was intended or not, or if the mother had been treated in the hospital for a considerable time during labor or if the baby was actually born in the hospital.
Even when planning status for OOH birth can be confirmed, the researcher still has the dilemma of what to do with appropriate transfers of women late in pregnancy for medical problems (breech baby, pre-term labor, PROM) or immediate transfer at the time of the initial labor evaluation to due to discovery of a high risk condition such as bleeding, fever, thick meconium, etc. Since some percentage of women (or their babies) who planned an OOH birth will eventually need, want or receive hospital-based medical care, so the question is how to fairly determine place-of-birth outcomes relative to the mother’s choice of OOH.
If midwives transfer all the complications that occur in their OOH practices to the hospital, the stats for OOH (with all problems automatically eliminated) might unrealistically portray OOH birth as 100% safe, while hospital birth — recipient of all those complicated OOH transfers — would look (but not really be) more dangerous. In an attempt to circumvent this problem, outcomes have been assigned to the “intended” (planned) place of birth, no matter who actually provided care, or what type of care was actually provided or where the mother actually labored (in or out-of-hospital) or where the baby was actually born.
Studies that focus solely on the pregnant woman’s plan to give birth OOH assign all subsequent data to the OOH-PHB cohort, even when a pregnancy risk factor or complication was identified by the birth attendant and a necessary transfer of care was initiated long before labor. Another aspect of this confounding factor is assigning neonatal outcomes to OOH care even when the mother was transferred to the hospital early in labor and 80% (or more) of the intrapartum care was standard obstetrical management — IV, Pitocin, EFM, immediate access to Cesarean surgery, perinatology services at delivery, etc — for many hours before the baby was born in the hospital.
Unfortunate, this attempt to make the statistical comparison more fair means the outcome of the care as it was actually received is not correctly identified. The initial “intention” or preference of the family for a situation that never materialized becomes more relevant than the actual situation and type of medical care received. Without knowing if the adverse events in question occurred at home with a professional (or experienced) attendant present (i.e., not a precipitous delivery before the midwife arrived) or happen in the hospital, or if the medical problem was avoidable vs. unavoidable, or if the parents declined prenatal testing or medically recommended treatments, there is no rational way to assess the impact of place-of-birth.
How the data for ‘intended’ place of birth is defined, collected and used makes a big difference. Done poorly, it merely trades one type of statistical dilemma for another, which means these particular OOH studies fail to answer the fundamental question of relative safety or provide us with “actionable” information in designing public policies, educational curriculums and identifying ‘best practices’.
Newspaper reporters and media spokespersons naturally assume that each of these must touted studies was based on rock-solid data and impeccable methodology. This would includes a full forensically investigation of each of these deaths so that all facts were verified and a complete set of specific information was available for each bad outcome and that conclusions of the studies was internally consistent with the data. But that is not the case for the this small subset of studies aggressively promoted by ACOG. In fact, the opposite is true. Because these studies tells us so little about the proximal cause and circumstances surrounding each of these individual incidence of neonatal death, it keeps their authors and the rest of us from coming to meaningful conclusions. With such rare events and small numbers, each adverse event could and should be specifically confirmed and forensically evaluated.
OOH maternity care is an articulated model that purposefully includes policies and protocols for transfer of care as needed. This is no different than the triage process used by small and medium-sized community hospitals. Hospitals routinely assess labor patients on admission for complications that require a higher level of medical service and arrange for those with such complications to be transported to tertiary care facility.
Nowhere in the scientific literature does one see maternal-infant outcome statistics used to evaluate a form of maternity care based on the hospital where the mother initially planned or preferred to give birth, but in fact did not actually give birth, either because she delivered elsewhere or developed a complication that required her to be transported to another facility. The current convoluted methodology of OOH birth would not be tolerated in any other aspect of modern healthcare and it is also not appropriate for place-of-birth research.
While the consensus of the scientific literature supports planned and attended OOH labor and birth as a responsible choice for healthy women with normal pregnancies, the lack of “standard characteristics” for OOH studies does a great deal of mischief and causes no end of grief for the midwifery profession. Studies on place-of-birth need to use standard scientific criteria that reduce personal bias and hidden political agendas, and instead helps inform public health officials and others who make policy decisions.
The only statistics on safety that are relevant to planned OOH birth are those that reflect outcomes for a normal term pregnancy that confirms the OOH status after onset of spontaneous labor and initial evaluation by the birth attendant. Only after the mother-to-be and her fetus are both confirmed to be essentially healthy and labor is at that point is normal can this mother’s labor and birth be documented as a planned OOH event. In addition, the actual place of birth, the timing of any transfer (how many hours before or after the birth) and the actual reasons for any labor or birth-related ‘bad outcome’ is crucial.
Finding Middle Ground in Science:
Currently the neonatal outcome statistics for each basic category of birth attendant (MDs and midwives) and the two settings is remarkably similar. According to a general consensus of the scientific literature, hospital and OOH is statistically equivalent as judged by the rate of neonatal deaths. However, both side have a handful of controversial studies that either show a slight increase in neonatal mortality in OOH birth or show a significant increase in obstetrical intervention and Cesarean sections rates in the hospital-based group.
Even though the numbers of are small – approximate 1 ‘excess’ neonatal death per a 1,000 — every doctor and every midwife has personally seen avoidable bad outcomes. If they are honest, they will have to admit that isn’t just the “other” category of practitioner that makes mistakes or otherwise exercises poor clinical judgment or has deficient skills. The apparent parity of outcomes between hospitals and OOH birth and between midwives and physicians represents parity in preventable mortality and morbidity, as each side loses some very small, but equal number of babies under circumstances that could have been avoided and should be improved upon.
As good as current outcomes are when compared to historical times and current third world countries, they could still be better. Some but not all of these poor outcomes are the cost of a system that does not have standard care characteristics for either category practitioners or either location for birth services. Logically speaking, if both professions addressed these essential quality-of-care issues head-on, we would see improved outcomes for mothers and babies.
For obstetricians and family-practice physicians, this includes a solid foundation in the principles and skills of physiological management, which would dramatically reduced number of medical and surgical interventions and operative deliveries. For midwives and others who manage childbirth physiologically, it would include a greater degree of caution and less hesitancy to consult, collaborate, co-manage or transfer care.
When caring for healthy women with normal pregnancies, trusting the wisdom of Mother Nature is a sound strategy. However, this strategy is even better when it is combined with the ancient wisdom of the Middle East, which counsels us to: “Trust Allah but tether your camel”. Of course this includes a sturdy rope and good knot-tying skills.
Part IV: Conclusions
