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Institute for Healthcare Improvement Takes on Maternity Care

April 28th, 2010 by avatar

The Institute for Healthcare Improvement (IHI), the leading nonprofit organization working to accelerate change in healthcare, has been in the news this month because its CEO, Donald Berwick, was recently nominated to head up the Centers for Medicare and Medicaid Services. (For those not familiar with Berwick, read his phenomenal article, “What ‘Patient-Centered’ Should Mean: Confessions of an Extremist“). Berwick himself and IHI’s Managing Director, Sue Gullo, RN, were key players in the recent Transforming Maternity Care Project coordinated by Childbirth Connection. Now, the IHI is rolling out programs to help hospitals and health care systems implement some of the work put forth in the project’s Blueprint for Action. These initiatives also coincide with the new Joint Commission perinatal core measures which hospitals may implement as of this month. Here’s what is on offer so far:

  • Earlier this month, IHI recorded Momentum for Maternity of the Safest Kind, a podcast with the Transforming Maternity Care leadership about trends in health care for pregnant women, new mothers, and newborns and the work needed to reliably provide safe and effective care, reduce disparities, and rein in costs.
  • On Tuesday, May 4 from 3-4 PM ET, Sue Gullo will host a public call to discuss the IHI’s work on improving safety in second-stage labor. The call can be accessed through the IHI Webex System (Click on Improving Perinatal Care Collaborative Info Call) or via land line at 866-469-3239 (enter the session ID 354 952 217*. More information can be found on IHI’s Improving Perinatal Care page.
  • A series of seven web-based sessions for hospital staff involved in quality improvement efforts will focus on the safe use of oxytocin for induction, starting with avoiding all elective deliveries before 39 weeks. The series begins May 14.

To keep up with other IHI offerings, you can follow them on Facebook or Twitter

WebEx Log-in Instructions:
* Go to ihi.webex.com (Note: There is no “www”)
* From the top of the page, select the “Event center tab”
* ” Improving Perinatal Care Collaborative Info Call” will be a listed session. From the status column, select “Join Now” and follow instructions.
To join by telephone only (or if you are having trouble joining via web):
Call (866-469-3239; click here for global call-in numbers <https://ihi.webex.com/ihi/globalcallin.php?serviceType=TC&ED=106051772&tollFree=1> ) and enter the session ID # (354 952 217*).  If you experience any difficulties, please contact Lauren at lmusick@ihi.org.

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A new vital sign for maternity care: duration of skin-to-skin contact after birth

April 26th, 2010 by avatar

If you haven’t heard, the Joint Commission, the organization that accredits U.S. hospitals, has recently rolled out a bundle of perinatal quality measures. These measures are designed for hospitals to track and improve their performance on indicators of perinatal quality, including the proportion of newborns discharged from the hospital having consumed only breast milk during their hospital stay. The US Breastfeeding Committee created a helpful document for hospitals, Implementing the Joint Commission Perinatal Core Measure on Exclusive Breast Milk Feeding (PDF). Right on the first page and repeated two more times, the Committee makes this suggestion:

Compliance with the new core measure may require facilities to modify their paper charts and/or electronic medical records. Thus facilities may want to consider charting modifications that support breastfeeding (such as length of time of skin-to-skin contact, especially immediately following birth). [emphasis is mine]

I don’t know how difficult it is to get hospitals to make changes to their documentation forms. I assume as more hospitals adopt electronic health records, the task is easier. However, even if changing the form is easy and inexpensive, staff will need to be briefed on the rationale for the change and trained to document the new data properly. This all adds to the complexity and cost of providing care, so it’s easy to see how some hospitals would just stick with their old way of documenting.

But if hospitals are serious about improving their exclusive breastfeeding rates, they should get serious about measuring the duration of skin-to-skin care. A new study in the Journal of Human Lactation demonstrates a strong dose-response relationship between skin-to-skin care and exclusive breastfeeding at hospital discharge. The data in fact come from a hospital quality improvement program carried out in 19 hospitals in California – the reason they were able to detect the dose-response relationship is that they were documenting the length of skin-to-skin contact as part of these quality improvement efforts. Using data from nearly 22,000 mothers and their healthy, full-term babies, the researchers found the dose-response relationship even after controlling for whether the woman intended to exclusively breastfeed, education, ethnicity, anesthesia, mode of birth, and other factors. One factor that was not reported and apparently not controlled for was history of prior birth and/or prior breastfeeding experience. This could be a significant confounder, but there is no reason to believe it would negate the strong and consistent findings – the dose-response pattern held up in multiple calculations applying various assumptions.

The quality improvement project that produced this study was supported by the Loma Linda University Perinatal Services Network, a network of hospitals working collaboratively to create policies and practices that keep moms and babies together after birth. Check out these great flyers and handouts they offer to promote early mother-infant attachment and breastfeeding.

SOFT

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Consider the Source: An Interview about Nitrous Oxide with Judith Rooks

April 25th, 2010 by avatar

Our Consider the Source series offers an inside look at research from the researchers themselves. In this installment, my guest is a prominent midwife-researcher who was the lead investigator on The National Birth Center Study published in the New England Journal of Medicine, researched and wrote the landmark book, Midwifery and Childbirth in America, and sits on the Editorial Board of the international journal of evidence-based maternity care, Birth, among many other distinctions. But she has not actually conducted any of the clinical trials on the topic at hand – nitrous oxide (also known as “gas and air”) for pain relief in labor.

Instead it was her experience overseeing arguably the most important systematic investigation of labor pain and its management that led Judith Rooks to begin advocating for greater access to nitrous oxide for laboring women. In this interview, Rooks discusses how she became so passionate about nitrous oxide, the American College of Nurse-Midwives’ new position statement on the topic, and why advocates for safe and healthy birth practices should join the movement to improve access to this important option for childbearing women.

Since many of my readers will be unfamiliar with nitrous oxide in labor, I offer this YouTube video of a woman using gas and air in the second stage of labor. If I could have edited out the editorializing by the TV producer, I would have! So please ignore her and have a look at the birth of baby Willow.

Science & Sensibility: You have been a very vocal advocate for increased access to nitrous oxide for laboring women. How did you get interested in nitrous oxide?

Judith Rooks: In 2001 the Maternity Center Association (MCA, since segued into Childbirth Connection) and the New York Academy of Medicine convened an invitational evidence-based symposium on the Nature and Management of Labor Pain. I directed this project on behalf of MCA and began by forming a multidisciplinary steering committee of experts. Penny Simkin was one of the first people I asked to serve on that committee. When she agreed, I asked her to help me develop an agenda for the seminar, and thus the topics to be addressed. Penny suggested that nitrous oxide (N2O) should be included, even though it was so little used and known in the US. She told me that it is widely used in many other countries and has advantages that are needed in this country. I had known almost nothing about it, but educated myself as best I could, after which I agreed with Penny.

At that time, as now, the University of California at San Francisco (UC/SF) and the University of Washington (UW) Hospital in Seattle were the only hospitals in the United States that were still offering N2O analgesia to women during labor. Dr. Mark Rosen, who had 30 years experience offering N2O analgesia to women during labor at UC/SF’s Moffitt Hospital in San Francisco, agreed to conduct a systematic review of the risks and benefits of N2O analgesia for labor and presented his findings during the symposium. Systematic reviews of all other labor analgesics used in the US were also conducted and presented at the symposium—one presentation each for parenteral administration of opioids, paracervical blocks, and nonpharmacologic methods, and three presentations on epidurals, two to deal with the extraordinary lack of consensus regarding the unintended effects of epidural analgesia on labor and its outcomes, and a third paper to describe side effects, necessary co-interventions, and the care required by women who labor with an epidural. Other systematic reviews were presented on the nature of labor pain, pain and women’s satisfaction with the experience of childbirth, and the degree to which American women have access to a choice of methods to relieve and/or help them cope with labor pain. Manuscripts of the systematic reviews were published in a special issue of the American Journal of Obstetrics and Gynecology.

I began to think more deeply about labor pain as a result of planning and directing this symposium, and I learned a lot from the experience: Epidurals can virtually eliminate labor pain but have strong negative effects on the normal physiology of labor, thereby causing a myriad of complications and other negative effects, including an increase in operative deliveries (forceps, vacuum extraction, or cesarean deliveries) and fewer spontaneous vaginal births. Opioids are not very effective at reducing pain and have negative effects on newborns. Paracervical blocks provide effective pain relief but are associated with adverse fetal and neonatal effects. Nitrous oxide is not a potent analgesia but is safe and seems to help most women who use it during labor. Nonpharmacologic measures help to relieve labor pain and have minimal or no side effects; but even women who want an entirely drug-free birth often need something more at some point during labor. Use of epidurals was increasing every year, as was the cesarean section rate and the even higher rate of total operative deliveries. I was and am still on the Editorial Board of Birth, a highly respected multidisciplinary international professional journal that focuses on pregnancy and birth. Reading and reviewing papers about childbirth in other countries made me increasingly aware that women in most English-speaking (or Scandinavian) countries have more options for pain relief during labor, whereas most women the US were increasingly being offered an epidural or nothing. I decided to try to “bend the curve” by expanding access to nitrous oxide.

Science & Sensibility: What do you see as the major benefits of nitrous oxide? Are there risks women should be aware of?

Judith Rooks: The major benefits are mainly lack of disadvantages associated with relying on epidurals, opioids and nonpharmacologic methods to relieve and help women cope with pain during labor:

After almost a century of use by many millions of women in countries with high standards of medical care and research, no studies or published observations have identified any negative effects of maternal use of nitrous oxide analgesia on the alertness and responsiveness of the newborn during the important early period of maternal-infant bonding or on early effective breastfeeding. The newborn of a woman who used nitrous oxide analgesia during labor is not at increased risk of respiratory depression. A pediatrician armed with a drug to counter the effects of opioids does not need to be present at the birth. Her newborn will not be admitted to a neonatal intensive care unit (NICU) for observation on the basis of risks associated with her method of labor analgesia.

Every analgesic and anesthetic drug that enters a woman’s body during labor passes through the placenta, enters the blood of her fetus, and remains active until it is detoxified or eliminated. Opioids (narcotics derived from opium and synthetic drugs that have the same effects) and the anesthetics used in epidurals are detoxified relatively slowly by the liver. Any opioids and anesthetics that are in the baby’s blood at birth have to be detoxified by the baby’s liver, which is immature and not very efficient. It can take several days for a newborn’s liver to eliminate them completely. Opioids depress respiratory function. Babies born with opioids in their blood may need to be resuscitated immediately after birth and tend to be sleepy and unable to nurse effectively. Anesthetics used in epidurals enter the mother’s blood in low amounts, but can still have effects on the newborn. N2O also passes through the placenta and enters the baby’s blood but is rapidly eliminated from the mother’s body (and thus the body of her fetus) through her lungs. Any nitrous oxide that is in the baby’s blood at birth is eliminated as the newborn takes its first few breaths of air. Opioids should not be used close to the time when the baby is expected to be born, yet many women need analgesia during a rapid delivery. Since nitrous oxide does not make the baby less responsive or depress respirations, it can be used up to and during the actual birth without increasing the risk of an unresponsive baby that needs to be resuscitated; it is never too close to the delivery for a woman to continue using nitrous oxide.

Nitrous oxide does not have any negative effects on the normal physiology of labor—the pulsatile release of endogenous oxytocin from the mother’s pituitary gland, maintenance of uterine muscle tone, the force and effectiveness of uterine contractions, blood flow to the uterus, the ability of the fetal head to rotate from a posterior position to an optimal position during second stage, and the mother’s ability to sense when and how to push most effectively, maintain upright positions, and change her posture as needed. There is no need to administer synthetic oxytocin (Pitocin) to make up for the lost effectiveness of endogenous oxytocin and no increased need to use forceps or force applied to the baby’s head by suction (vacuum) to rotate its head from a posterior position in order to deliver the baby vaginally. Because there are no negative effects on the normal physiology of labor, there is no reason to delay starting nitrous oxide during early labor out of concern that it will slow down or stop the woman’s labor before it can get a good start, and there is no reduction in the rate of spontaneous vaginal births.

In contrast, epidurals diminish the pulsatile release of endogenous oxytocin from the woman’s pituitary gland, which is in her brain. Pulses of natural oxytocin produced in the mother’s brain stimulate labor contractions. Reduction in the mother’s own supply of oxytocin causes labor to slow and become less effective. Most women who have epidurals are given an intravenous drip of synthetic Pitocin to make up for this loss. But a steady IV drip of synthetic Pitocin is very different from the synchronized release of natural (“endogenous”) oxytocin produced in and released from the mother’s brain. During normal labor there is a feedback loop between the release of oxytocin by the woman’s pituitary gland and the frequency and intensity of her contractions. Unfortunately, there is no way for an IV Pit drip to know how frequent, long or intense the mother’s contractions are. Without the feedback loop, it is easy to give a mother too much Pitocin, which can cause contractions that are too frequent, too long, and too intense. The arteries that bring blood to the baby through the placenta pass through the uterine muscle. When the contractions are too frequent, too long and too intense, the blood supply to the fetus can be severely compromised because the uterine muscle squeezes the arteries, not allowing enough blood to get through. Pitocin is the drug most commonly associated with preventable adverse effects of labor on babies. In 2007 Pitocin was added to the Institute for Safe Medication Practices short list of medications “bearing a heightened risk of harm,” which may “require special safeguards to reduce the risk of error.” Approximately half of all successful malpractice suits against obstetricians are related to misuse of Pitocin.

Nitrous oxide is not associated with any of the other known adverse effects of epidurals. These include :

  • a sudden drop in the mother’s blood pressure, in some cases leading to an emergency cesarean section
  • persistent fetal occiput posterior position in labor, highly associated with cesarean section for slow labor progress
  • need for bladder catheterization, which increases the risk of urinary tract infections
  • maternal fever in labor, which, despite not being infectious in origin, will often lead to neonatal sepsis work-ups and separation of mothers and babies after birth

Finally, a woman who is having an epidural requires continuous electronic fetal monitoring and an intravenous infusion as precautions against such complications. As a result, a woman who is having an epidural is tied to her bed by tubes and wires that connect her to the equipment that is providing the epidural, the intravenous infusion, and the equipment for continuous electronic fetal monitoring. None of these things are necessary for a woman who is using nitrous oxide, although her mobility is constrained by the need to access the source of the Nitronox (a blend of 50% nitrous oxide and 50% oxygen). But many women who use nitrous oxide don’t use it during their entire labor. Some women set it aside once their cervix has opened fully and they feel the urge to push. If the equipment for use of nitrous oxide is portable, a woman can continue to use it while walking, going to the bathroom, or relaxing in a tub of warm water. And it is not necessary for her to be attached to other equipment.

Although there are several relatively effective nonpharmacologic ways to help women cope with labor pain, most of them are not provided in most American hospitals. Some women who enter labor wanting to avoid an epidural come to a point, especially during their first birth, at which they feel that they cannot take the pain any longer and must have some kind of pharmacologic help. Although a pain crisis can occur at various points during labor, it is not unusual for a women to become exhausted and ask for an epidural during the period shortly before her cervix becomes completely dilated, when she would begin to feel the urge to push. Some women get a second wind once they move into the second stage of labor, but if she gets an epidural at that point, she will have it on board for the remainder of her birth. Although a woman who wanted to avoid an epidural should be able to change her mind and have one, she should also have access to a method of pain relief that is simple and fast to start, takes the edge off her pain and helps her cope, but can be put away—or continued, at her choice—once the crisis has passed, if she wants to re-engage and push with full sensation while giving birth.

Every woman and labor is unique. There is no single best method of labor analgesia. Every method has advantages and disadvantages, and different women value different things. Women should have choices, and some will do better and be more satisfied if they can use a variety of methods at different stages of their experience of giving birth.

Nitrous oxide can be started simply, quickly, easily and safely and begins to take effect almost immediately. There is no need to wait until an anesthesiologist or nurse-anesthetist is available to insert a catheter into the epidural space surrounding the woman’s spinal cord—a delicate procedure that requires sterile conditions. And, because nitrous oxide does not interfere with the normal forces of labor, it is not necessary to wait until labor is well established before the woman can begin to use it. Women who want to have an epidural can use nitrous oxide while they wait to be able to have an epidural.

After a brief period of explanation and supervision, nitrous oxide is self-administered through a mask that the woman holds to her own face. Self-administration allows the woman to determine when and how much nitrous oxide she uses. She can pick the mask up and use it as much or as little as she wants. She can also control the amount of nitrous oxide she takes in by adjusting the speed and depth of her inhalations. Being able to control her use of analgesia gives many women a reassuring sense of self-control.

Rapid elimination of N2O through the lungs means that if a woman decides after starting to use nitrous oxide that she doesn’t like it or no longer needs it, she can set the mask down and stop inhaling the gas. Her body will be completely free of nitrous oxide in less than 5 minutes. In contrast, it may take many hours for a woman’s body to be completely free of the effects of an opioid or epidural.

Science & Sensibility: How many hospitals or birth centers are using nitrous oxide in the United States?

Judith Rooks: To my knowledge only two hospitals in the United States are using as of early April 2010—the University of Washington (UW) Hospital in Seattle and the University of California at San Francisco’s Moffitt Hospital in San Francisco. The company that was manufacturing the equipment for self-administration of Nitronox (the 50%/50% blend of nitrous oxide and oxygen that’s used during labor) lost its subcontractor almost two years ago, resulting in a total lack of new equipment. As a result, hospitals and birth centers that wanted to start using it have not been able to move forward. Now another company is preparing to begin making new equipment. At least two hospitals and one birth centers are in line to buy the equipment and begin to use it as soon as it becomes available. Some other hospitals are considering it. I believe that there will be considerable early demand from smaller hospitals that cannot provide access to epidurals at night and during weekends.

Science & Sensibility: The ACNM Position Statement discusses two concerns with the use of nitrous oxide in labor: reproductive health risks for health care personnel who have repeated exposures to nitrous oxide in the workplace and a theoretical risk of injury to neurons in the newborn’s brain. These are cited as barriers to increased availability of nitrous oxide in the U.S. How have other countries addressed these concerns?

One long-standing concern relates to possible reproductive risk (more months to conceive, possibly due to early spontaneous abortions) among female health workers, including midwives and nurses who work closely with women using nitrous oxide analgesia during labor. This was a problem during an earlier time, especially in the United Kingdom (UK), where many hospitals were not well ventilated and people weren’t aware of the need to prevent the breath exhaled by women using nitrous oxide analgesia from entering the ambient air. Nitrous Oxide inhaled by a woman during labor stays in her body for only a short period of time before it is eliminated by her lungs. It is important for her exhaled breaths to be captured and pulled out of the room. Now that this is understood, a “scavenging” capacity has become an integral part of the equipment for using N2O. The woman breathes N2O and oxygen from a mask and exhales carbon dioxide and N2O back into the mask, which suctions it away. Eventually it is released into the outside air at a time and in a place and manner that are safe. Although nitrous oxide is a “greenhouse gas”, the amount used for medical and dental purposes is minor compared to other sources of nitrous oxide in the earth’s atmosphere, and it is not a poisonous gas that people should be afraid of in low concentrations. Nitrous oxide is produced when organic materials that contain nitrogen are burned or broken down in other ways. The leaves of deciduous trees contain a nitrogen that is turned into N2O by bacteria in the soil under a tree. Humans have always been exposed to low concentrations of naturally occurring nitrous oxide and have evolved an effective way to deal with having it enter their bodies.

The National Institute of Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) are responsible for safe use of all anesthetic and analgesic gases in the United States. Their recommendations for maximum occupational exposure to N2O are more stringent than the rules that govern use of N2O in many other countries. Current OSHA recommendations call for limiting occupational exposure to N2O to not more than an 8-hour time-weighted average concentration of 25 parts per million (ppm). Although the Netherlands adheres to the same standard, the UK, Italy, Sweden, Norway and Denmark set 100 ppm as their upper limit. NIOSH’s recommendation to limit occupational exposure to nitrous oxide to 25 ppm was established during the 1970s, without benefit of actual data. Nevertheless, the American Society of Anesthesiologists (ASA), NIOSH and OSHA all agree that this standard has been effective in protecting American health workers.

The concern about a theoretical risk of injury to neurons in the brain of a human fetus while its mother uses N2O analgesia during labor resulted from research that found seemingly severe but reversible nerve cell damage in the brains of baby rodents, mainly rats, exposed to very high concentrations of N2O, as well as alcohol and many other neuro-active drugs, including all general anesthetics. The period of susceptibility in rodents coincides with the time during which the immature brain is growing and developing at a rapid rate—the first week of life for a baby rodent. The comparable period for humans is from the 6th month of gestation until about three years of age. The research leading to this concern began with research on the pathology that underlies fetal alcohol syndrome and expanded to looking at whether other drugs might causes similar damage to the brains of baby rats. A large body of laboratory research was done and published in the 1990s but did not gain widespread attention until about 2007, which also happened to be the time when midwives and others were becoming concerned about the lack of access to labor analgesia choices for women in the US, resulted in growing interest in nitrous oxide. By 2008 two US hospitals were considering beginning to offer nitrous oxide analgesia to women during labor—a major academic medical center in the southeast and a Kaiser Permanente hospital in California. Both hospitals were leaning towards going forward with N2O obstetric analgesia when leaders of their anesthesiology departments attended a national professional meeting during which this body of research was summarized and discussed. Shortly thereafter the anesthesiology departments of both hospitals decided against any expanded use of nitrous oxide, decisions that were probably minor from their perspective. The much bigger concerns among the anesthesiologists who learned about the damage to rat brains from exposure to nitrous oxide related to the important role of N2O as a component of anesthesia for long but essential surgeries on infants and toddlers.

Nitrous oxide has long been a staple of anesthesia for surgery, not as a single agent but as part of a mixture of anesthetic gases. The addition of nitrous oxide makes it easier to both induce and bring a patient out of anesthesia with less stress, including preventing unpleasant and sometimes very frightening memories. Those benefits are considered so important for children that concerns about risks associated with exposing children to nitrous oxide created a crisis for anesthesiologists and pediatricians, who continued to use nitrous oxide during pediatric surgeries until more information on the clinical significance of the baby-rat studies for humans could be assessed. This all occurred in the context of a wider challenge to continued used of nitrous oxide in anesthesia practice in the US. Development of new anesthetics that can be administered intravenously has made it possible to give adult patients pure oxygen to breathe during surgery. Several studies have shown that patients who breathe 100% oxygen during surgery have fewer infections and better wound healing, apparently due to higher levels of oxygen in their body tissues. A randomized trial that proved this was published in Anesthesiology (the journal of the American Society of Anesthesiologists) in 2007 under the title “Avoidance of Nitrous Oxide for Patients Undergoing Major Surgery.” The study was conducted as part of the Evaluation of Nitrous oxide In a Gas Mixture for Anaesthesia (ENIGMA). An editorial published in the same issue of Anesthesiology pointed out that the important finding of the study was the benefit of high inspired oxygen rather than avoidance of nitrous oxide, which, she pointed out, “is certainly useful for inhalation inductions in children, as well as for analgesia in laboring parturients [women giving birth] or in patients having dental procedures.”

In October 2008 Anesthesiology published a comprehensive review of the biologic effects of nitrous oxide authored by an international team of leading anesthesiologists from the UK and Germany. They noted that, although N2O causes morphologic neurotoxicity in the immature brains of baby rats, this “occurs at doses in excess of those normally administered in clinical practice (i.e., in hyperbaric conditions) and resolves within 3 hours.” They further found no evidence of neuropathology in neonatal rat brains from exposure to N2O concentrations less than 75%. The abstract summarized the situation:

Nitrous oxide is the longest serving member of the anesthesiologist’s pharmacologic armamentarium but remains a source of controversy because of fears over its adverse effects. Recently, the (ENIGMA) trial reported that that nitrous oxide use increases postoperative complications; further preclinical reports have suggested that nitrous oxide may contribute to neurocognitive dysfunction in the young and elderly. Therefore, nitrous oxide’s longevity in anesthetic practice is under threat. In this article, the authors discuss the evidence for the putative toxicity of nitrous oxide, from either patient or occupational exposure, within the context of the mechanism of nitrous oxide’s action. Although it would seem prudent to avoid nitrous oxide in certain vulnerable populations, current evidence in support of a more widespread prescription from clinical practice is unconvincing.

Blood levels of nitrous oxide in women during labor never go very high. Self-administration protects the mother and fetus from getting too much N2O. If the mother becomes drowsy, her hand will fall away from her face, the supply of nitrous oxide will turn off, and she will begin to breathe room air. Nitrous oxide as used during labor is not a very potent analgesia—enough to take the edge off the pain but not a concentration that is even close to what was being given to the poor baby lab rats used in the studies that caused so much concern.

Science & Sensibility: Do you think there are other barriers to increasing access to nitrous oxide: perhaps economic, logistical, or cultural?

Judith Rooks: Lack of equipment has been a big problem during the past two years because the demand for nitrous oxide analgesia was not great enough for the company that had produced the equipment for many years to find a new subcontractor to make the equipment when the one that had been doing so stopped. It turned out to be the problem of all “orphan drugs”, for which there is not enough demand for large companies to invest in producing a supply to meet a limited demand. Now a new company is preparing to begin making new equipment, but it has been a big problem.

Epidurals are big money makers for hospitals and, of course, for anesthesiologists, whereas nitrous oxide is an old, off-patent, cheap drug that can’t compete as a money maker (but may at some point compete as a money saver, as the US moves towards placing value on cost-effective health care). Profit is a powerful force in American health care. If no one is making a profit, no one is pushing for a product to have a place on the shelf, whereas those who are making big profits are always trying to push the product that is not profitable off the shelf.

Once anesthesiologists decided to introduce epidurals for labor analgesia it became important to get rid of anything that might compete. If a hospital or physician wants to be able to tell pregnant women that they can have an epidural during labor, the hospital has to make a commitment to providing access to an epidural 24 hours a day every day of the year. It requires more than 5 full-time people to provide any service 24/7, and it costs a lot to pay full-time salaries for 5.2 anesthesiologists and/or nurse anesthetists. In order to make it practical for a hospital to providing labor epidurals on a 24/7 basis, it is necessary for a large proportion of women who give birth at that hospital to have epidurals. Nitrous oxide was maligned as old fashioned, dangerous to the health of nurses and midwives, making women vomit and thereby posing a threat to their lives because they might inhale some of their vomit, etc. Bad-mouthing nitrous oxide is still going on very actively, whether by ignorance of changed facts (e.g., much lower doses than were used decades ago, scavenging to prevent contamination of the air), repetition of unfounded rumors, financial considerations, or a desire to avoid the need to provide the time-intensive care needed by women who are experiencing some degree of pain.

Most obstetricians were delighted to hand responsibility for dealing with labor pain to anesthesiologists. Some time ago I had protracted communication with a fine obstetrician who banned continued use of nitrous oxide analgesia in an major university hospital when he went there to head the department of obstetrics and gynecology during the 1990s. After he offered several unconvincing rationales for having banned it, he said that he is just uncomfortable seeing women in pain. An epidural is the only method that can totally obliterate labor pain for an individual woman and result in a completely quiet labor unit, with no woman making any sound associated with discomfort. Many obstetricians may resist any change that would put them in the position of having to deal with more women who are experiencing some level of pain.

Most young nurses (all but a few OB nurses at this point) have had little if any experience with women who are laboring without an epidural and have never been taught or had role models to help them learn how to comfort and support a woman who does not have an epidural. Continuing education for labor-unit nurses tends to focus on the technical aspects of care, such as electronic fetal monitoring. Little value is assigned to being able to work effectively with a woman who is trying to go through labor and give birth without an epidural. The few nurses who are interested and able to do it may be criticized by their peers for “spoiling” the patients. Doulas would be a good solution but are not widely accepted in obstetrics. In addition, doulas are most effective as agents of the pregnant woman, but most women can’t afford to hire on and it is not clear that doulas employed by a hospital would be as effective.

Epidurals are clearly the most effective way to eliminate pain during labor. That makes them “the Gold Standard”, even though complete obliteration of pain is not the real goal for many women during labor. Superficially it may seem silly, stupid or sadistic to advocate for introduction of a “less effective” method of analgesia for women during labor. And women are most likely to want to use the method that is “best”.

Few women have full information about the pros and cons of various approaches to reducing and helping women cope with labor pain. The benefits and harms are complicated, time during prenatal visits is limited, and childbirth education is now being provided mainly by hospitals which slant it to encourage women accept and want the kind of care that the hospital can provide most expeditiously.

American health care is remarkably isolated from what is happening in other countries. Although the recent focus on the need for “health care reform” has informed many Americans that health status of Americans is poorer overall than that of the citizenry of many wealthy countries, most Americans think that the only thing wrong with American health care is that some people can’t afford it. There is little understanding that overuse of invasive procedures can actually result in harm, and that more, more expensive, and more “sophisticated” care is not always better. In addition, it is hard for Americans to learn anything about health care from another country. Many American physicians don’t read other English-language medical journals and discount research conducted in other countries as not being as good, important or valid as studies done in the US. As a result, we rarely benefit from progress that is being made in other countries. Most of the use of nitrous oxide analgesia occurs in other countries, so most of the research on it comes from other countries too. Most American physicians don’t have any idea that two of our best academic medical centers, UC/SF and the University of Washington, provide nitrous oxide anaglesia to women during labor.

Nitrous oxide analgesia is most compatible with the midwifery model of intrapartum care, and the supply of midwives is very limited in the United States.

The Joint Commission on Accreditation of Hospitals (JCHA) mandates regular pain assessments of all hospitalized patients, mainly by asking patients to rate the degree of pain they are experiencing using a standard 0 to 10 Numeric Rating Scale. Asking women who are trying to cope with labor pain to rate the degree of pain they are experiencing at regular intervals is counterproductive, since women who don’t want or can’t have an epidural are focusing on something else; it isn’t helpful to interrupt their focus by asking them to think about pain. Some tools that replace use of the Pain Assessment Rating Scale with a way for nurses and midwives to assess how the woman is coping with labor have been developed. I believe that Penny Simkin has developed such a tool, and one was described in a recent issue of the Journal of Midwifery & Women’s Health. This approach is acceptable to the JCHA but is not widely known or used.

Science & Sensibility: If consumers or health care providers are interested in reintroducing nitrous oxide in their communities, what steps should they take?

Judith Rooks: Pregnant or hope-to-become-pregnant women should talk to others, especially maternity care providers in their areas, about the need for nitrous oxide as an option for women who will give birth in local hospitals. Talk about it. Ask about it. Request it. Find out who is responsible for the hospital at which you will or would use for a birth- some kind of board of directors is responsible. Get their names and addresses, and send them letters asking for this. Do the same for the leaders of the departments of obstetrics and anesthesiology. Invite someone who can speak about this to give a talk somewhere in your city or town and get other women (and their partners) involved. Ignorance is the enemy, and in this case it is not just ignorance. Many professionals who think they are well informed about options for analgesia during labor are ignorant about options to epidurals but don’t know—and would be insulted by any inference—that they are ignorant. Don’t antagonize people and make enemies, but provide opportunities for them to learn more. Go on talk radio programs. Local public affiliates of National Public Radio (NPR) are usually open to discussions of topics of interest. Inform yourself thoroughly first. Reading and having a copy of the ACNM Position Statement on Nitrous Oxide for Labor Analgesia is a good place to start. This blog post is also full of authoritative information.

To arm yourself fully with the most current information, you should consider joining the nitrousoxideduringlabor listserv. Go to (http://health.groups.yahoo.com/group/N2Oduringlabor/) and follow directions to join. After you join, return to the listserv home page and click on “Files” in the light blue sidebar on the left side of the page to go the Files section, which contains copies of important published papers and other documents relevant to use of N2O analgesia during labor. As a member of the listserv you have access to all of those documents, as well as most of the messages that have been sent to members of the listserv. The files are listed alphabetically based on the name the given to the gave to the file when it was posted on the website. For example, an important paper by Sanders et al. is listed alphabetically after a very important systematic review of the best available evidence about the safety, risks and use of nitrous oxide for labor analgesia authored by Dr. Mark Rosen, Chief of Obstetric Anesthesia at the University of California at San Francisco and published in the American Journal of Obstetrics and Gynecology in 2002. Both are key documents. Mickey Gillmor, who is on the faculty of the largest midwifery education program in the US (the Frontier School of Midwifery and Family Nursing) helps me run the N2Oduringlabor website.If you have any trouble making this work for you, please let Mickey or me know. My email address is jprooks1@comcast.net. Mickey’s email address is mickey.gillmor@gmail.com.

This advice basically applies to health care workers too.

I think that N2O analgesia is going to become increasingly in demand as the growing imbalance between the supply of anesthesiologists and nurse-anesthetists to provide 24/7 access to OB epidurals and the need for some kind of relatively effective analgesia for women during labor. I believe that women are currently being urged to accept being induced (which leads to more cesareans) or have an elective preemptive cesarean in order to avoid the possibility of going into labor over the weekend or at night with no choice but a hospital that does not have weekend or night coverage for epidurals. I assume that is part, maybe even a significant part of the reason for the great and growing disparity in the average number of births that occur on specific days of the week in the US. As this problem becomes more apparent—amid increasing evidence of increased harms to both mothers and babies of unnecessary inductions and cesareans—the animosity among many anesthesiologists and some obstetricians towards any method of labor analgesia other than the “gold standard” epidural will have to wane.

Information about nitrous oxide is slowing seeping out to women, not all of whom want an epidural; that is why I am doing this interview—as long and tedious as it may seem. Our Bodies Ourselves, Childbirth Connection, and a growing number of books, movies, journals and blogs are bringing more and more women better, fuller and more evidence-based information about their choices and chances to have a non-surgical physiologic birth.

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Why my first year blogging has changed how I see everything

April 22nd, 2010 by avatar

Photo courtesy of merfam via Creative Commons on Flickr

As I mentioned the other day, this week is my one-year blogiversary. Like many bloggers, I look back on my first year and realize that I had no idea what I was getting myself into when I clicked “publish” to submit that first post. I didn’t know how much time and mental energy it would take, how strong a sense of community and mutual admiration I would feel with other bloggers, or how many professional doors it would open.

I also had no idea how great the disruptive potential of social media could be. In one year, I have gone from a vague understanding of social media to a deep conviction that, leveraged properly, it represents one of the most potent threats to our dysfunctional maternity care system. I have come to believe that power is up for grabs in our new connected world, and consumers and their advocates are in a better position than ever to seize it.

I’m going to be talking about some of my thoughts on what Web 2.0 means for healthy birth advocacy on ICAN’s Radio Show tomorrow. I decided that in preparation for that interview and in honor of my blogiversary, I’d collect some of my favorite experiences from the past year that convinced me that social media may once and for all translate the dissemination of knowledge into better, safer care for women and babies.

VBAC_WebImage1. For the first time in birth advocacy history, social media played a central role in disseminating the proceedings of scientific meeting with major national and even international significance. Tweets from the conference spread far beyond the choir, and bloggers banded together to write about VBAC as a vital option before the meeting and to break down the panel’s recommendations for consumers after the fact. The NIH Panel even gave a “shout out” to the bloggers, a move that I argued was intriguing if not ground breaking.  Susannah Fox from the Pew Internet and American Life Project stopped by the blog to confirm my suspicions that NIH’s attention to the blogosphere may be part of a broader awakening of government agencies to what she calls, “the participatory internet.”

2. I discovered that those of us advocating for better, safer maternity care share much in common with and have a lot to learn from healthcare consumers facing serious illnesses. No, pregnancy and birth are not diseases. But last summer, I discovered The Society for Participatory Medicine, and realized that people facing life-threatening or serious chronic illness have been busy using the internet to shape care in ways the birth community has not yet embraced – but could. In a post titled, Let’s Get On This Train: Participatory Medicine and the Future of Maternity Care, I wrote :

Although I had envisioned some pretty nifty things we could do with the internet to improve maternity care, I had my mind pretty well blown recently when I came across a white paper called e-Patients: How They Can Help Heal Healthcare. The paper, the brainchild of a truly visionary doctor, introduces a new web-powered paradigm of healthcare in which patients are empowered, engaged, equipped, and enabled to improve their own health and the quality and safety of the care they receive. It also provides compelling evidence that this new paradigm is already revolutionizing health care in ways we couldn’t have envisioned just a decade ago.  One of its prominent supporters recently wrote, “If you have not read the e-Patient White Paper, you do not understand the future of medicine.”

By reading the society’s blog, e-Patients.net, and engaging with participatory medicine enthusiasts on Twitter, I learned about sites like Patients Like Me and Cure Together, where people are tracking and sharing their health data online and generating new knowledge about diseases and treatments. I also learned about the movement to put medical records in the control of patients rather than hospitals and doctors, a movement that is gaining serious momentum in Washington. And I even got invited to submit a few guest posts.

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3. I saw important research find its way directly into the hands of people who could act on it, skipping the “middle men” (a.k.a, the years-long process in which university-based research trickles through journals and professional conferences to professionals who can’t keep up with every new study and even when they do face cultural or logistical barriers to implementing change in their institutions.) In November I interviewed cord-clamping researcher, Judith Mercer, and comments came in from a medical student, a NICU nurse, a representative of the March of Dimes, several consumers, childbirth educators, and an obstetrician who trains residents. That doctor, Nicholas Fogelson, went on to look at the literature on timing of cord-clamping himself and wrote one of his most widely read and shared blog posts to date, boldly and matter-of-factly titled: Delayed Cord Clamping Should Be Standard Practice in Obstetrics.

4. I had access to people in high places.  When the whole country (myself included) was swooning over Atul Gawande’s brilliant analysis of health care costs published in the New Yorker, I wrote a post titled The Maternity Conundrum: One Thing Atul Gawande Doesn’t Get About Healthcare Reform. It turned out to be the post that would put my blog “on the map,” and next thing I knew Judy Norsigian from Our Bodies Ourselves emailed it to Atul Gawande, copied me, and I almost fainted. Then a bunch of months later, I left some pretty critical feedback on the blog of a prominent hospital CEO about his handling of a scheduled cesarean broadcast on The Today Show, and he wrote back, and a lengthy conversation ensued. I don’t think I’ve ever had such direct access to influential thinkers, and am sure that I wouldn’t have had it not been for good old social media.

5. I spent months reading the published literature on evidence-based care in the second stage of labor for the book I’m writing, only to learn far more by reading the 30+ posts submitted for the Healthy Birth Blog Carnival on pushing. I already had a strong belief that the qualitative literature told a more important story about the harms of conventional obstetric management of second stage than the quantitative literature ever could. What is the blogosphere if not a huge repository of qualitative data?  The stories ranged from triumphant to heartbreaking, and collectively made an extremely strong case for physiologic second stage care. The carnival also provided a chance to look comparatively across healthcare specialties. It’s not often that critical care nurses weigh in on how things are done on the labor and delivery floor, but in a follow-up post to the Healthy Birth Blog Carnival, blogger and father of four, Man Nurse Diaries, wrote:

Now, I’m not an OB nurse. But in critical care, when you urgently need to give clear commands, ONE PERSON DOES IT, whether you’re getting a patient out of bed or coding them. This is so the patient doesn’t fall on the floor as three nurses tell them to go three different ways; it’s so the code efforts proceed in an orderly fashion; it’s so the combative patient has one professional to listen to rather than a room full of hostile voices. But from what I saw, this doesn’t happen in obstetrics. It’s a free-for-all. The stories in the carnival reflect this; it’s really worth covering.

I’m thrilled to have a year of blogging under my belt and to have had this wonderful soapbox thanks to Lamaze International and my wonderful, engaged readers and contributors. But after My Year of Social Media, I’m not all that interested in looking back. I’m facing squarely forward because I think we’re in for an interesting ride.

Photo courtesy of merfam via Creative Commons on Flickr.

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What’s Behind the Cochrane? (or…, “The Good News About Midwives Gets Better!”)

April 19th, 2010 by avatar

Note: If this post looks familiar, then thank you for being one of my dedicated readers who has followed me from the very beginning. Yes, this is a repost of my very first blog post and this week marks the first anniversary of Science & Sensibility! Happy blog-aversary to us!  Later this week, I’ll share a few of my favorite posts and other milestones over the past year. And if you missed this one a year ago, here’s an “understanding research” lesson all wrapped up in a package of very good news (ok, not-so-new news) about midwives!

Often, the closer I look at a study, the less confident I become about the results. I’ve learned that you can’t always trust a paper’s title or abstract, and media coverage of new studies can be woefully misleading, even when it is not carefully orchestrated by those with a vested interest (which it often is). Being advocates for “evidence-based care” means not just knowing that a study has been published, but knowing whether that study is any good, and in what circumstances (if any) the results are relevant and reliable. It also means having our guard up against deeply flawed studies that shape policy and practice despite their limitations. (Henci Goer has done a fantastic job deconstructing some of these influential studies in her series, When Research is Flawed.)

A systematic review synthesizes all of the literature on a given topic, using rigorous criteria for which studies will be included. For instance, Cochrane systematic reviews are typically confined to randomized, controlled trials in which there is no evidence that the randomization process has been intentionally subverted. For this reason, Cochrane reviews are considered the “gold standard” of evidence.

But what happens when the trials that make up a systematic review themselves have flaws or limitations? We end up with Cochrane reviews that can mask problems in the literature, and we can inadvertently put the evidence-based “stamp of approval” on a practice that still needs to be studied further. This is referred to as the “garbage in, garbage out” phenomenon, and we see plenty of it in the obstetric literature.

One kind of garbage that Cochrane reviews rarely address is crossover. This is when some of the participants randomized to the “control group” (e.g., no intervention) end up getting the intervention that is being tested. This problem is rampant in trials of induction, pain relief, and episiotomy, among others. Some women randomized to “expectant management” end up getting induced; some women randomized to “non-epidural pain management” end up getting epidurals; some women randomized to “conservative use of episiotomy” end up getting episiotomies, and so on.  This makes it much more difficult to use our statistical toolbox to discover differences between the two groups, and as a result we see smaller differences, or even no difference. The “evidence-based” conclusion then becomes “there’s no difference is unwanted outcomes, so the intervention is harmless.” But “no difference” can also mean “this study wasn’t big enough to find a difference” or, in this case, “there was too much crossover to detect a true difference.”

The crossover problem usually drives me crazy because it often serves to perpetuate medical-model bias and medical-model practices. But I had an “ah ha” moment when I discovered a crossover-of-sorts problem in the 2008 Cochrane systematic review of midwife-led care. This review was released to fanfare within the birth community. Finally, the enormous body of literature on midwifery had been synthesized by Cochrane reviewers and the conclusions were firmly in favor of midwife-led care! The results were, indeed, unusually impressive. While the conclusions of many Cochrane reviews are couched in tentative language and call for more research, the reviewers here concluded decisively, “Midwife-led care confers benefits and shows no adverse outcomes. It should be the norm for women classified at low and high risk of complications” (p. 17). Still, when I looked a little closer, I was perplexed that some of the differences the Cochrane reviewers found were small or even non-existent. What? No difference in c-sections? Only a small difference in episiotomy? What’s going on here?

A kind of crossover is the culprit, and this time it means that the good news just gets better! It turns out, of the 11 trials comprising over 12,000 women, in all but 1 of these trials (with only 318 participants), some or all of the women in the control groups were actually cared for by midwives. The difference was that that these midwives were supervised by physicians, or they shared their client caseload with physicians. The Cochrane reviewers were not interested in comparing midwives versus doctors. They took it for granted that midwifery care itself is safe, effective, and satisfying. This is, after all, a global consensus, to which the United States remains in stubborn and lonely opposition. Working from the assumption that midwives are an important part of the maternity care system, the question becomes how should we organize that system? Who should coordinate the care of childbearing women – midwives or doctors? Midwife-led care means that women receive their primary maternity care with the midwife, and the midwife engages an obstetrician or other consultant when some aspect of the woman’s or baby’s care falls outside of the scope of independent midwifery practice. This stands in stark contrast to the typical arrangement in the United States, when midwives are supervised by obstetricians or employed by hospitals, and obstetric protocols and productivity standards drive midwifery practice.

Women often believe that going to an obstetrician practice that employs midwives is getting “the best of both worlds.” The Cochrane review of midwife-led care in fact tells us that such arrangements are ineffective, inefficient, and may be hazardous to the health of women and babies.

Citation: Hatem M, Sandall J, Devane D, Soltani H, Gates S. Midwife-led versus other models of care for childbearing women. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004667. DOI: 10.1002/14651858.CD004667.pub2.

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