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Saturday, July 02, 2011

Immediate Cord Clamping (ICC) vs.
Delayed (or “physiological”) Cord Clamping (DCC)

Dr. Nicholas S Fogelson MD · practices obstetrics & gynecology in Honolulu, Hawaii

He blogs for Academic OB/GYN

Dr. Nicholas Fogelson: immediate clamping and cutting of the umbilical cord deprives the newborn of nearly 20mL/kg of her potential blood volume. The iron in the red blood cells is essential for normal brain development. All babies need to get the majority of their placental blood. Those stem cells are very precious (as are the red blood cells), and were meant to be in the baby to lay down his immune foundation for the rest of his life. [See “Mankind’s first natural stem cell transplant” by Jose N. Tolosa, Dong-Hyuk Park, David J. Eve, Stephen K. Klasko,Cesario V. Borlongan, Paul R. Sanberg, J. Cell. Mol. Med. Vol 14, No 3, 2010 pp. 488-495.]

Preterm deliveries are an area of even greater interest, given the data to suggest impact on critical endpoints of sepsis and intraventricular hemorrhage. Three groups of researchers have independently reported that early clamped infants have a much higher incidence of cardiac murmurs during the first 14 days of life.

Immediate cord clamping is an intervention shown to have substantial physiologic impact on a term fetus in terms of iron stores, blood volume, and hemoglobin. Blood, intended to perfuse the newly functioning lungs and other vital organs, is discarded along with the placenta. Possible consequences include breathing difficulties and anemia, especially in vulnerable babies; long-term effects on brain development are also very plausible. 2

Randomized data to date suggests a measurable clinical benefit to delayed clamping (and restoration of a more physiological transition from placental to pulmonary circulation). “After crying starts, the baby received a transfusion of nearly 100 minutes of blood within one minute; this was forced by maternal uterine contraction into the baby’s venae cavae, liver, heart and lungs.” [George Malcolm Morley, MB ChB FACOG] No data has found a danger in delayed cord clamping.

Delaying/physiological cord clamping at C/S.

These babies need their own blood probably as much or more than the vaginally delivered infants.

It’s not difficult at all to delay cord clamping at cesarean. We put the baby down on the mom’s draped legs and put a sterile towel over the infant to keep it warm (face uncovered of course.) We clamp at 60-90 seconds and then hand off to the pediatricians. Anecdotally, infants that are not vigorous at delivery always seem quite vigorous at 60 seconds, even without any active resuscitation.





Given that immediate cord clamping is the intervention, I think we have the evidence required to suggest that right now we should be delaying cord clamping after term deliveries.

Jaleel et al “Delayed umbilical cord clamping at birth seems to be safe and can be expected to reduce the prevalence of anaemic newborn babies in our community.” J Pak Med Assoc. 2009 Jul;59(7):468-70.
Timing of umbilical cord clamping and neonatal
haematological status.
R. Jaleel, F. Deeba, A. Khan

Hutton et al “Delaying clamping of the umbilical cord in full-term neonates for a minimum of 2 minutes following birth is beneficial to the newborn, extending into infancy. Although there was an increase in polycythemia among infants in whom cord clamping was delayed, this condition appeared to be benign.” JAMA. 2007 Mar 21;297(11):1241-52.
Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials.
 Hutton EK, Hassan ES.

Levy et al “Although a tailored approach is required in the case of cord clamping, the balance of available data suggests that delayed cord clamping should be the method of choice.” J Perinat Med. 2006;34(4):293-7.
Timing of cord clamping revisited.
Levy T, Blickstein I.

J Matern Fetal Neonatal Med. 2010 Nov;23(11):1274-85.
Timing of umbilical cord clamping: new thoughts on an old discussion.
Arca G, Botet F, Palacio M, Carbonell-Estrany X.

Friday, September 10, 2010

A commentary about the Wax et al meta-analysis (the newest controversial study published by the obstetrical profession), the Joint Commission on hospital accreditation's new 'perinatal core measures', which are justifiable critical of our highly and unnecessarily medicalized system of obstetrically-based care for healthy women and the use of peer-reviewed studies by the American College of Obstetricians & Gynecologists to derail public attention, manipulate the media, and unduly influence public opinion:

In my opinion, the media hype generated by ACOG over the Wax et el (1) place-of-birth analysis is a red-herring. This controversy is not about midwifery vs. obstetrics, or choice of hospital vs. out-of-hospital (OOH) birth setting. Instead, this badly flawed study is being used to distract the public and the press from the real story – the need to normalize childbirth practices and adopt cost-effective maternity care for healthy childbearing women.

On April 1, 2010, the Joint Commission on hospital accreditation issued a directive the obstetrical profession to lower its intervention rates, particularly targeting the run-away use of elective induction, early labor hospital admission and Cesarean in healthy first-time mothers who had a single baby in a vertex or head-down position.

It is helpful to remember that the basic purpose of maternity care is to preserve and protect the health of already healthy women. Mastery in normal childbirth services for healthy women with normal pregnancies means bringing about a good outcome without introducing any unnecessary harm or unproductive expense. The ideal maternity care system seeks out the point of balance where the skillful use of physiological management and adroit use of necessary medical interventions provides the best outcome with the fewest number of medical/surgical procedures and least expense to the health care system.

Unfortunately, our 20th century system of ‘pre-emptive’ intervention has not been able to live up to this promise.

We currently have a hundred-year old system based on the routine medicalization of normal birth and many other obstetrical practices that don’t serve healthy mother and babies, but do introduce artificial and unnecessary risks for both. A historical decision made by the obstetrical profession in 1910 declared that obstetrics, as a surgical specialty, was to be the standard of care for everyone, including healthy women.

However, there was never any scientific basis for a maternity care model that identified surgeons as primary care providers for a healthy population or systematically used obstetrical interventions and invasive procedures on all laboring women. It is a fluke of history that a hundred years later we are still conducting normal birth as a surgical procedure.

Prior to the discovery of antibiotic in the 1930s, normal birth as a surgical procedure was part of a strategy to reduce fatal infections in maternity patients. This included dividing childbirth between two different professions and separating labor from birth. Nurses were to provide medical management for the first stage of labor, a process that included keeping women in bed and administering repeated injection of drugs for pain. The nurses were expected watch carefully and notify the patient's doctor when the mother started pushing. Birth as a surgical procedure is called 'the delivery' and was to be perform by surgically-trained specialist. Typically the mother was put to sleep with general anesthesia and delivering the baby included episiotomy, forceps, manual removal of the placenta and putting in stitches afterwards.

The types of intervention and rationales for their use have changed several times since 1910. By 2010 forceps had long ago been replaced by Cesareans and epidural had taken the place of general anesthesia. These newer forms of intervention are far safer, but the overall number of medical and surgical procedures has gone up with each and every decade. This is completely inexplicable, as childbearing women are many times healthier now that they were in 1910 and have far fewer pregnancies due to effective contraception. Modern medicine has access to antibiotics and many other wonderful new drugs, as well as ultrasound technology and other prenatal testing to discovery serious problems before labor even starts. Despite great advances in public health and medical ability, the operative rate has risen from 10% in 1910 to 70% in 2010.

The Listening To Mothers’ Survey' in 2002 and 2006 identified the medical intervention rate to be 99%, with an average of 7 medical interventions for every woman in labor. The aggregate rate for surgical procedures during childbirth was approximately 70% -- episiotomy, forceps, vacuum extraction or Cesarean section and suturing the perineal or abdominal incision. These procedures not really different than the ones used in a century ago.

For the last 30 years, this newer version of 1910 preemptive intervention policies has come to been known as "active management". Unfortunately, there is still no scientifically evidence that the new version is any safer or more cost-effective for healthy childbearing women than physiologically-based care. However, there considerable evidence that active management and other current policies routinely introduce unnecessary risk and are associated with iatrogenic complications. 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.

Nonetheless, it seems that ACOG hopes to justify this highly medicalized status quo in the face of strongly-worded criticism of these very practices by the Joint Commission on hospital accreditation. To qualify for government reimbursement hospitals must be evaluated and approved by the Joint Commission [3], so the Commission's opinions are really important to hospital administrators. You can’t appreciate the historical politics behind Dr. Wax’s hospital vs. OOH study without reading the new “core measures” for hospital-based birth care published by the Commission on April 1, 2010. These guidelines can be accessed on-line @:

http://manual.jointcommission.org/releases/TJC2010A/PerinatalCare.htm.

Readers may be surprised to hear that the Joint Commission is critical of the excessively-medicalized, unproductively expensive, and unsafe childbirth practices for healthy women that have become the norm in the US. Whatever the original intentions of Dr. Wax and the other authors, ACOG is now using the study’s assertions to support its own preferences -- the continuing medicalization of normal childbirth -- despite a direct challenge to these policies by the Joint Commission.

Based on impeccable scientific evidence, the Commission’s directive includes instructions for reversing “the Cesarean epidemic” and the escalating rates of elective induction and hospital admissions early in labor. None of these common practices have improved outcomes for babies, but they do result in increased complications for mothers and are implicated in a rising maternal mortality rate.

The Joint Commission’s guidelines could not be clearer. They start out by saying:

“The removal of any pressure to not perform a cesarean birth has led to a skyrocketing of hospital, state and national cesarean section (CS) rates. Some hospitals now have CS rates over 50%. Hospitals with CS rates at 15-20% have infant outcomes that are just as good and better maternal outcomes. (Gould et al; 2004). There are no data that higher rates improve any outcomes, yet the CS rates continue to rise.” [emphasis added]

No wonder some women try to avoid an unnecessary C-section by planning an OOH birth under the care of a midwife or family-practice physician. The wisest strategy for ACOG would be take the Commission’s report to heart and come up with innovative plans to implement these recommendations. Such a strategy would incorporate the principles of physiological management of normal birth in a healthy population in place of the current policy of 'active' obstetrical management. It would also end it's hundred year war against the midwifery profession.

But instead of 21st century progress, ACOG is sticking to its usual fear-based PR campaign that aggressively promotes the same old “more is better” notion, despite all evidence to the contrary. ACOG has chosen to use its considerable resources to re-direct the public’s attention to the self-generated controversy about OOH (less than 1% of all births), in an effort to distract us from the poor obstetrical practices being used in the other 99% of hospital births. [Listening to Mothers Survey, Childbirth Connections; 2002 + 2006]

Elective induction and early admissions in labor have become so routine they are almost the standard for obstetrical care, but the Joint Commission identifies both of these interventions with a significant increase in a hospital’s rate of operative delivery, prematurity and neonatal complications. Scientific evidence cited in Joint Commission’s core perinatal measures include instructions for dramatically reducing induction, early admission and elective Cesarean surgeries.

According to the Joint Commissions: “… almost 1/3 of all babies delivered in the United States are electively delivered, with 5% of all deliveries in the U.S. delivered in a manner violating ACOG/American Academy of Pediatrics’ guidelines. Most of these are for convenience, and result in significant short-term neonatal morbidity (neonatal intensive care unit admission rates of 13- 21%) [Clark et al; 2009].

“… compared to spontaneous labor, elective inductions result in more cesarean deliveries and longer maternal length of stay [Glantz, 2005]” … “[Dr] Main et al (2006) found that over 60% of the variation [in C-section rate] among hospitals can be attributed to first birth labor induction rates and first birth early labor admission rates. The results showed if labor was forced when the cervix was not ready the outcomes were poorer”

“The American Academy of Family Physicians (2000) also notes that elective induction doubles the cesarean delivery rate. Repeat elective cesarean sections before 39 weeks gestation also result in higher rates of adverse respiratory outcomes, mechanical ventilation, sepsis and hypoglycemia for the newborns [Tita et al., 2009].

Another statement in the Commission’s new Core Measures acknowledges what many childbearing families, midwives and every L&D nurse in America has known for decades – that the use of obstetrical intervention is far more about the physician’s personal preference than scientific evidence. According to the Joint Commission:

“Many authors have shown that physician factors, rather than patient characteristics or obstetric diagnoses, are the major driver for the difference in rates within a hospital (Berkowitz, et al., 1989; Goyert et al., 1989; Luthy et al., 2003).”

While the Joint Commission never uses the word “physiological management” or directly recommends replacing this excessively-medicalized model of care with physiologically-based practices, that is the only available method to lower the rates of invasive procedures and reduce the harm (and cost) associated with run-away medicalization. A consensus of the scientific literature shows physiological management of normal childbirth by professional birth attendants to be the evidence-based care for healthy women with normal pregnancies. This cost-effective model is used worldwide by those countries that get far better outcomes for much less money.

By every measure of excellence for maternity care (except the unconfirmed issue of neonatal mortality), even the Wax analysis concluded that the non-medicalized approach results in dramatically improved outcomes. The “RESULTS” section of the study’s abstract states:

Planned home births were associated with fewer maternal interventions including epidural analgesia, electronic fetal heart rate monitoring, episiotomy, and operative delivery.

These women were less likely to experience lacerations, hemorrhage, and infections.

Neonatal outcomes of planned home births revealed less frequent prematurity, low birth weight, and assisted newborn ventilation. … planned home and hospital births exhibited similar perinatal mortality rates ...”

Nonetheless, ACOG’s strategic use of the Wax analysis of OOH birth was effective in derailing effective public discourse on the aforementioned obstetrical excesses. There has been absolutely NO coverage of the real media bombshell – the Joint Commission the April 1, 2010 publication of these new perinatal core measures designed to reduce elective and operative interventions. ABC's Good Morning America Health did a segment on 'at-home birth', provocatively titled "Home Birth vs. Baby-At-Risk". They did NOT cover or even mention the Joint Commission's new core measures for excellence in perinatal care or discuss the 'Cesarean epidemic' as the public health and economic problem that it is.

Conclusions:

Whether in hospital or out-of-hospital, normal care for normal birth, in combination with the appropriate use of medicalization as needed (or as requested by the mother), is the safest and most cost-effective model for a healthy population. Regardless of which system one is referring to, the crucial words are the same: 'not disturbing the spontaneous biology of normal labor and birth unless necessarily', 'timely access’ to the fruits of modern medical science when indicated and ‘appropriate use’ of medical services as required.

I would never want to live in a place or an era without timely access to comprehensive medical and surgical services, which depend on hospital facilities and well-trained obstetricians, so I never see this as 'us versus them' issue. I want hospitals to work and work well. I want physicians of all kinds to be skilled and seamlessly available. I also expect them to be knowledgeable about physiologically-based practices and cooperative with mothers and midwives. We actually are all on the same team -- the one that wants to use the best practices all the time for everyone.

Unfortunately, ACOG's favorite assumption -- that more aggressive medicalization automatically improves normal childbirth -- is incorrect and out-dated. As long as this mistaken idea is enthusiastically embraced by leaders of the obstetrical profession, it will be impossible to get our hands around the very real social, medical and economic problems we face. As a country, we cannot hope to compete successfully in a global economy against other countries and parts of the world that depend on normal care for normal childbirth at a 1/10th of the cost of our bloated and dysfunctional system.

Instead of stepping stones to progress, ACOG's 19th century notions have become stumbling blocks that keep keep physicians and midwives from cooperating with one another. They stymie efforts by ACOG fellows to participate in a system of seamless care to women cared for by midwives. What is really needed is a cooperative approach by all stakeholders - childbearing women, all categories of birth attendants and hospitals - that seeks out innovative solutions and finds ways to make "best practices" more widely available to more people.

According to a review of the scientific literature, the best and most cost-effective outcomes for healthy mothers and babies are consistently associated with three healthcare-related circumstances (2). In combination, these three basic elements are equally advantageous to industrialized countries as well as developing ones. In a perfect world, these safe motherhood measures and mother-baby-father and family-friendly practices would provide a foundation for a cooperative and complimentary relationship between all categories of birth attendants and be perfectly in alignment with the 'Perinatal Core Measures' of the Joint Commission:

(a) Antenatal care with risk-screening & referral for medical evaluation or treatment as indicated
(b) Experienced birth attendant(s) skilled in physiological management who are present or immediately available at the mother's discretion through out active labor, birth and postpartum-neonatal period
(c) Access and appropriate use of hospital-based obstetrical services for complications or if medical care is requested by the mother

In a balanced and cooperative system healthy women would not have to choose between an obstetrician and a midwife or between hospital and home in order to receive physiological management for normal childbirth. No matter who provided maternity care, women would have access to the best obstetrical services if they desire or require them, while being confident of receiving appropriate, physiologically-based care for a normal labor and spontaneous birth.

Under those circumstance, place-of-birth would become what it was always suppose to be -- the right choice for the particular situation for that specific mother & fetus -- with hospital and OOH both seen as equally responsible choices in an integrated, cooperative and 'minimalist' model based on ‘best practices’.

Ultimately, all maternity care is judged by its results -- the number of mothers and babies who graduate from its ministration as healthy, or healthier, than when they started.

References:

1. Maternal and newborn outcomes in planned home birth vs planned hospital births: a meta-analysis; Joseph R. Wax, MD, F. Lee Lucas, PhD, Maryanne Lamont, MLS, Michael G. Pinette, MD, Angelina Cartin, Jacquelyn Blackstone, DO; published online 02 July 2010.

Presented at the 30th Annual Meeting of the Society for Maternal-Fetal Medicine, Chicago, IL, Feb. 1-6, 2010.

2. Identifying the Essential Qualities of Maternity Care -- Evidence-based policies and a plan for action -- an annotated essay by Faith Gibson

3. About The Joint Commission -- An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 18,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

Our Mission: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. Read more.

Vision Statement: All people always experience the safest, highest quality, best-value health care across all settings. Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

The Joint Commission evaluates and accredits more than 18,000 health care organizations and programs in the United States. An independent, not-for-profit organization, The Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care. To earn and maintain The Joint Commission’s Gold Seal of Approval™, an organization must undergo an on-site survey by a Joint Commission survey team at least every three years.

The Joint Commission is governed by a 29-member Board of Commissioners that includes physicians, administrators, nurses, employers, a labor representative, health plan leaders, quality experts, ethicists, a consumer advocate and educators. The Board of Commissioners brings to The Joint Commission diverse experience in health care, business and public policy. The Joint Commission’s corporate members are the American College of Physicians, the American College of Surgeons, the American Dental Association, the American Hospital Association, and the American Medical Association.

The Joint Commission employs approximately 1,000 people in its surveyor force, at its central office in Oakbrook Terrace, Illinois, and at a satellite office in Washington, D.C. The Washington office is The Joint Commission’s primary interface with government agencies and with Congress, seeking and maintaining partnerships with the government that will improve the quality of health care for all Americans, and working with Congress on legislation involving the quality and safety of health care.

Monday, June 28, 2010

The Problem with Using Place of Birth
as Proxy for Style of Intrarpartum Management

faith gibson, LM CPM

MANY MEDICAL AND MIDWIFERY PROFESSIONALS, as well as birth activists and consumers, confuse birth setting (hosp. vs. OOH) with intrapartum management style or may use these terms interchangeably, sometimes to mean an actual physical location, and other times to refer to a management style.

In this paradigm, 'home' has become a frequent proxy for non-medical or physiologically-managed care without use of, or access to comprehensive obstetrical services, while hospital has become a proxy for medical management. We generally assume that the hospital-based medical model is universally safer, while planned home birth care is inevitably more risky. This makes two erroneous assumptions simultaneously -- that PHB attendants routinely reject the appropriate and timely use of obstetrical services and that routine medicalization of healthy women is universally positive or at the very least, neutral.

I would never want to live in a place or an era without timely access to comprehensive medical and surgical services (which depend on hospital facilities), so I never see this as an 'us vs. them' issue. I want hospitals to work and work well. But these proxy assumptions make it impossible to get our hands around the very real social and medical problems we face. Instead of stepping stones to progress, these notions become stumbling blocks that keep society from finding innovative solutions and making "best practices" more widely available to more people.

Even in places like Africa, we generally apply these same proxy assumptions. People frequently refer to the high maternal mortality rate in developing countries as a realistic measure of how dangerous childbearing is. However, an exhaustive study of all maternal deaths occurring in one particular region of The Gambia is instructive.

It begins with the information that all but 2 of these maternity patients were in hospital at the time of their death, and one of those died of an infection after returning home after a Cesarean section performed in the hospital. The vast majority of these women either delivered in the hospital or were admitted early enough in the course of a potentially fatal complication to have been successfully treated by current medical standards. It was not location but quality of care that was the critical issue. The most frequently preventable cause of unnecessary MM identified by the study was a tragic lack of simple economic resources (hospitals with no running water, no drugs, no banked blood, no gas to run the hospital generator for electric lights in the OR, no doctor on site who could perform a CS, etc) combined with unresponsive or inappropriate actions (or omissions) by the hospital staff.

As former administrator of a professional liability group from 1998 to 2000 for CNMs and licensed midwives in three states, I was privy to reports of malpractice cases against obstetricians and midwives in both hospital and OOH settings. Unfortunately there were a number of instance in which it was evident (med-mal carrier settled out of court) that a baby died or was neurologically damaged by the elective use (physician preference) of medically unnecessary obstetrical intervention in a healthy mother who did not herself want the intervention (ex., induction or augmentation to speed things up) or the OB was not in the hospital and *did not come* when asked to by the nurses.

There were also a small number of OOH mfry cases with bad outcomes. These fell into two general categories. The first, and luckily the rarer category, was total disregard for well-established, evidence-based practices by either the parents or the midwife. In those instances, it was not location (home), but lack of common sense and good judgement by either one or both. This is also is not a "place of birth" issue. The answer to this problem is better education of the public, more responsive maternity care so that parents do not become pathologically fearful of medical services, and more effective preparation and regulation of midwives in the responsible practice of their profession, irrespective of location.

The more frequent, (but still statistically rare) situation was a genuinely unpredictable adverse event such as prolapsed cord with baby at a +1 station or placental abruption in a normotensive primipara. One certainly could argue that if the mother had been in the hospital 15 feet from a fully staffed OR in a tertiary care institution with 24-7 in-house surgical, anesthesia and perinatal services, the baby could have been rescued, maybe w/o suffering neurological damage, maybe not.

But as a former L&D nurse who often worked in smaller or rural community hospitals, I also know of instances in which the mother was in the hospital but the doctor was at home. Unfortunately, the same critical issues applied, with the same poor outcomes. Thirty-nine minutes from decision to incision can be far too long, no matter if it represents transport time from the parents' home to an awaiting institution or time spent (waisted!) by nurses frantically paging "any doctor in house stat to L&D", while calling the OB at home, then paging him and finally waiting for him to arrive while the nurses prepare the mother for a crash C-section that turned out to be too little too late.

In far too many places, PHB is the only circumstance where true physiological management can be legally and fully employed. This reflects OB department policies and med-mal carrier protocols that require obstetricians to follow a strictly-defined medical model of care. This frequently includes elective induction at 40-41 wks and the preemptive use of IVs, continuous EFM, a medically-defined schedule for progress in labor, and liberal use of operative delivery for any number of minor variations. Any obstetrician who fails to maximumly medicalize each and every patient risks a lawsuit in which plaintiff's attorney's will parade a line of "expert witnesses" happy to testify that physiological management is "substandard" in the context of professional care by an MD trained in the surgical specialty of obstetrics.

This artificially forces us into this proxy state of affairs that appears to pit hospital against PHB. But in a rational evidence-based system, no healthy women should ever have to choose between a midwife and a physician or btw home and hospital in order to receive physiologically based care for a normal birth.

Statistically-speaking, the relative risks for planned place of birth in each location are approximately the same. Since we all know of preventable perinatal deaths and emergency hysterectomies subsequent to care in both places, the logical conclusion is that *both sides* are having bad outcomes that are preventable by today's standards. While occurring for different reasons, the bad outcomes from each side are only canceling each other out and thus do not represent a true measure of relative risk. That means we can stop arguing about place of birth and instead focus on improving all aspects of maternity care by all categories of birth attendants in all locations.

Over the last 100 years, a consensus of scientific research has identified physiologically-based birth services, regardless of location, to be a relatively safe and therefore responsible choice when provided by trained midwives with access to and use of comprehensive obstetrical services to treat complications or if requested by the mother. Every year one or more credible study on physiological management in non-medical settings is added to this growing body of research. However, five particular sources of research data do the best job of identifying the specific information needed to make science-based decisions relative to national maternity care policy for the United States.

The hottest controversy currently is an ideas spawned by ACOG in 2008 that rejects all available research data because the studies are not randomized controlled trials. According to ACOG policy, the status quo -- maximum medicalization of healthy childbearing under a strict obstetrical model -- is the only 'proven' standard for safe and responsible maternity care and must be maintained until such time as randomized controlled trials can be done to address the question of safety. However, its obvious to everyone else that randomized trials under the terms insisted on by ACOG can never and will never be done

Fortunately for the rest of us, that is not the conclusion arrived at by Australian authors Bastia, Keirse, and Lancaster in a paper published in the BMJ in 1998 on perinatal death in PHB. They were able to distinguish the forest from the tress and do a superb job of debunking this idea by identifying (again) that the real issue is not place of birth. When we look across the board at M&M statistics (historical and contemporary) and records of malpractice litigation, its clear that none of the categories of birth attendants have a monopoly on poor judgement, failure to use common sense and/or inappropriate use of resources.

The introduction to this Australian study hits all these high notes and gives us somewhere dependably solid to stand:

"Despite decades of political and academic debate the relative merits of home-versus-hospital birth remain unproved. This is likely to remain so.

Although home and hospital offers different risks and benefits for birth, neither has standard care characteristics. In fact, the range from safe to unsafe may be wider within each location than it is between them. Addressing what constitutes safe birth practice at home and in hospitals may be a more pivotal concern than attempting to quantify the theoretical differences attributable to place of birth. .... In the Netherlands, where 30% of birth are planned to be at home, there is a widely accepted list of criteria for home birth. When home birth is uncommon, opinions and practices can vary more widely."

These authors observed that when high-risk obstetrics is practiced in an OOH setting, the outcomes disfavor PHB (surprise, surprise!). However, when this high-risk group is removed from the calculations-- a category the majority of midwives and physicians agree is generally best served by making physiological care available to them in a hospital setting -- PHB is demonstrated as relatively safe for mothers and babies as compared with hospital-based medical management.

I have grouped the other 4 studies mentioned above together as a set. They include (1) unattended OOH, (2) lay midwife-attended OOH, (3) professional midwife-attended OOH and a meta-analysis of medically-managed hospital births by obstetricians, FP physicians and certified nurse midwives. This configuration of outcome data includes a "control group" of unattended births which allow us to compared 'care' vs 'no care' and then to compare the specific care of the 3 major groups of birth attendants to one another and to "no care".

One must establish a baseline for "no medical or mfry care" in order to determine the innate riskiness of childbearing in an essentially healthy population, to determine if medical and mfry care make an over-all positive contribution (what economists refer to as 'value added") and finally to statistically calculate the manner and magnitude of medicine & midwifery's ability improve maternal-infant outcomes in a cost-effective fashion. Only in this way can we actually distinguish the qualities of maternity care that are essential (safety + cost-effectiveness) from those that represent traditional customs and preferences of professional providers, but do not directly contributed to improved maternal-infant outcomes via cost-effective "best practices".

(1) The control group consists of women with the same general health and demographic characteristics that are seen in the CDC birth registration data. This is predominately healthy, white, middle-class women who had economic access to all categories of maternity care providers and settings, but in this case, purposefully chose unattended births. Data on this group of unattended home births came from Indiana state mortality statistics for a fundamentalist religious group that all rejected medical care under all circumstances – no prior diagnosis or treatment of chronic medical problems, no risk-screening of mothers during pregnancy, no prenatal care, no trained attendant during childbirth and no emergency transfer of mother or baby with ife-threatening complications to a medical facility (a situation similar to rural parts of the developing world).

Out of 344 births, the unattended group had 6 maternal deaths and 21 perinatal losses.The baseline mortality rate for unattended childbirth was one maternal death per 57 mothers or MMR of 872 per 100,000 live birth (92 times higher than Indiana’s MMR for the same period) and one perinatal loss for every 16 births or PNM rate of approximately 45 per 1,000.

(2) Planned Home Birth in an impoverished and medically-indigent population attended by experienced lay midwives. These maternity patients were risk-screened one time by a public health officer prior to be approved for PHB under the care of a lay midwife. However, state laws did not authorized non-nurse midwives to carry oxygen or emergency anti-hemorrhagic drugs (Pitocin) or to suture perineal tears. These county-registered midwives were required to transfer patients with complications to a local hospital in an appropriate and timely manner. The lay midwife-attended group had no maternal deaths and 3 perinatal losses per 1,000.

Note: This study also reported the perinatal mortality rate for medically indigent women in the same rural regions of North Carolina who delivered unattended, often because local hospitals turned away laboring women who did not have the prescribed ‘cash in hand’. These unattended births had a dramatically increased perinatal mortality rate ranging from 30 to 120 stillbirth and neonatal deaths per 1,000, a perinatal mortality rate consistent with 3rd world countries and unattended births among the religious group in Indiana. [Note again that the take-home message the same -- its not the place of birth but the quality of care and the crucial preventive quality is physiologically-based services, not high-end obstetrics]

(3) Planned Home Birth in a general population attended by nationally-certified direct-entry (non-nurse) midwives. All clients were risked-screened and received prenatal care and those with medical or pregnancy complications were referred to medical services. Professional midwives monitored maternal vital signs and fetal heart tones during labor and were authorized to carry emergency supplies such oxytocin (Pitocin + Methergine), IV fluids, oxygen, neonatal resuscitation equipment and to suture perineal lacerations. Twelve percent of PHB patients were transferred to the hospital during labor or after birth, the majority of
 whom were first-time mothers. Cesarean rate was under 4% for PHB women hospitalized during labor.
This group had no maternal deaths and 2.6 perinatal losses per 1,000.

(4) Planned Hospital Birth for low and moderate risk women -- labor attended by a professional nursing staff, routine use of continuous electronic fetal monitoring, IVs and epidurals; birth conducted as a surgical procedure by a physician or certified nurse midwife. Medical intervention rate for this group was 99%; aggregate surgical intervention rate was 70% (episiotomy, forceps, vacuum extraction and Cesarean section). The CS rate was approximately 25% in 2002. This group had no maternal deaths and a neonatal mortality rate of 1.3 per 1,000. 
Studies of obstetrically-managed hospital birth in low-risk women give a range of NNM from a low of
 0.79 to 4.1.

Note: The routine use of prenatal screening in the hospital population in conjunction with termination of affected pregnancies during the pre-viable state results in an artificially lowered rate of PNM due to a reduced rate of babies carried to term with lethal anomalies.

As measured by the outcome statistics of the four groups -- unattended, lay midwife-attended, professional midwife-attended and hospital-based, medically attended -- the most efficacious strategy for preventing 
maternal and perinatal mortality and morbidity consists of three simple aspects 
of maternity care that balance safety and cost-effectiveness and apply regardless of place of birth.

They are:

(1) Access to prenatal care, on-going risk-screening & referral to medical care for evaluation or treatment as indicated

(2) The presence of an experienced birth attendant during labor, birth and immediate postpartum-neonatal period

(3) Access to hospital-based services for complications or if requested by the mother

Of the three birth attendant categories, the physiologically-based (i.e., non-medical) care by lay midwives demonstrated the most extraordinary level of cost-effectiveness and reduction in both maternal and perinatal mortality when compared to unattended birth and NNM rates comparable to professional midwives. This good outcome was achieved by providing childbearing women with access to risk-screening during the prenatal 
period and referring those with serious medical or pregnancy complications to
obstetrical services. The mother and unborn baby were monitored during active labor by capable midwives, who also arranged to transfer patients with complications to obstetrical
 services at the county hospital.

This simple access to prenatal care and physiological management during the intrapartum and postpartum-neonatal period reduced perinatal mortality by 20 to 40
 times as compared to the mortality statistics for unattended women and at a small fraction of the expense, was able to lower
 the maternal mortality rate to levels equal to that of hospital-based
-obstetrical care. Lay birth attendants are not an option within the structured healthcare systems of North American, which serve an educated population who rightfully expect their healthcare providers to be professionally trained, regulated by the state, able to carry emergency drugs and equipment and to repair simply perineal lacerations as a part of their normal scope of practice. However, lay midwives are an eager and reliable group that are able to provide safe care within a cost-effective system that dramatically improves mother-baby safety in developing countries.

When taken together, these five studies offer great certainty about what makes maternity care safe and effective and gives us a solid starting place. We know that childbearing is unnecessarily and unacceptably risky when women are denied (or refuse) the benefits of 20th century biological science and modern healthcare. We know that three simple, cost-effective steps reduce this high background rate to a level equivalent to most developed countries. National health policy must education the public to the very real dangers of 'no care' and then consistently provide circumstances that make such situations extremely rare by supporting this trilogy of skilled prenatal care that includes timely access to medical services during pregnancy, experienced birth attendance during labor, birth, the immediate PP & neonatal period and comprehensive obstetrical services whenever indicated for the treatment of health problems, complications and emergencies.

Again it must be noted that these are NOT place-of-birth dependent, but they do depend on integrating these three distinct categories of birth attendants (professional midwives, family practice physicians, and obstetricians) and both hospital and OOH birth settings. In such a system, the individual management of pregnancy and childbirth would always be determined by the health status of the childbearing woman and her unborn baby, in conjunction with the mother’s stated preferences, rather than the occupational status of the care provider(obstetrician, GP physician, or midwife) or the planned location of care. To do otherwise is illogical.

It is useful to take into account the enormous benefit that physiological management of labor and spontaneous birth in healthy women contributes to safe maternity care. This is the form of care routinely provided by general practice physicians and midwives in those countries with the best maternal-infant outcomes.

Simply put, the physiological principles of normal maternity care should be integrated with the best advances in obstetrical medicine to create a single, evidence-based standard for all healthy women with normal pregnancies. This integrated standard should apply universally to all categories of birth attendants when providing care to healthy women and be used in all birth settings, with comprehensive obstetric services reserved for those who develop a complication or if requested by the mother.

For essentially healthy women in an intregrated system, physiologically-based childbirth services would be provided by family practice physicians and professionally-trained midwives, with appropriate access to the services of obstetricians, perinatologists and other specialists as necessary. Only this articulated model of maternity care can bringing evidenced-based maternity care into the mainstream of our healthcare system and consistently provide safe and cost-effective services to a healthy population of childbearing women and their unborn and newborn babies.

The most efficacious form of maternity care for an essentially healthy population is always the method that provides “maximal results with minimal interventions”. This is defined as a beneficial ratio of interventions to outcomes for each childbearing woman. It factors in mortality and morbidity rates for mothers and babies both, as well factoring in the immediate, delayed and downstream cost. The ideal maternity care system seeks out the point of balance where the skillful use of physiological management and adroit use of necessary medical interventions provides the best outcome with the fewest number of medical/surgical procedures and least expense to the health care system.

Creating such a rationally-based maternity care system would require a calm and fair-minded coalition of professional groups, willing to learn how to cooperate effectively with one another. The goal (already modeled by the Canadian system) would be a complimentary scope of practice and cooperative style of care among the different categories of birth attendants, a cost-effective model of care that is to the benefit of patients and professional alike.

Lessons for Evidence-based Maternity Care in the 21st Century :

Under those circumstance, place of birth would become what it was always suppose to be -- the right choice for the particular situation for that specific mother & fetus -- with PHB and hospital both seen as equally responsible choices in an integrated, cooperative and 'minimalist' model based on "best practices".

References:

B-1 Maternal Mortality in the Gambia: PhD Thesis by Mamady Cham
B-2
Paper #1 Maternal Mortality in Bansang Hospital, The Gambia - Levels, Causes and Contributing Factors
B-3
Paper # 2 Maternal Mortality in Rural Gambia: What do we need to know to prevent It?
B-4
Q & A: What we can do to prevent maternal deaths

Study #1 Perinatal & maternal mortality in a religious group avoiding obstetric care -- Am Jour Obst Gyne 1984 Dec 1: 150(7):926-31

Study #2: "Home Delivery and Neonatal Mortality in North Carolina", Burnett et al; JAMA, December 19, 1980, Vol. 244, No. 24, p. 2741-2745

Study #3: Outcomes of planned home births with certified professional midwives: large prospective study in North America; Kenneth C Johnson, senior epidemiologist; BMJ 2005;330:1416 (18 June),
doi:10.1136/bmj.330.7505.1416

#4 Meta-analysis - Perinatal MR for planned hospital birth reflects a consensus of scientific literature, CDC birth registration stats and data on obstetrical intervention levels in general population from the "Listening To Mothers" survey, Childbirth Connection; 2002 and 2006