A recent research paper, Relationship Between Cesarean Rate and Maternal and Neonatal Mortality was published on December 1, 2015 in the Journal of American Medical Association (JAMA). This new study calls into question the long standing World Health Organization recommendation of a 10-15 percent cesarean rate as the point where, beyond that number, we see an increase in maternal and neonatal mortality. This paper has created major discussions and feedback amongst both physicians, researchers and consumers. I had the opportunity to ask Neel Shah, MD, MPP, one of the co-authors of this paper, some questions about his research and what it all means. Dr. Shah is an Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, and associate faculty at the Ariadne Labs for Health Systems Innovation. I am grateful for his willingness to dialogue with me and help us all to understand more about this critical discussion. You can read more information about Lamaze International's response to this research here. Next Tuesday, Henci Goer will compare and contrast this paper and several other recent publications that also assess the demarcation line for a safe number of cesareans. You will want to be sure to come back for this valuable follow up on December 22nd.

Sharon Muza: One of the challenges of this analysis was the lack of consistent data for all 194 countries in the World Health Organization. More than 11% of the countries included in the study did not have any cesarean rate data for the years examined. In some cases, data was imputed or extracted from other sources in order to be able to compare apples to apples. Can you speak to this challenge and how it might have impacted the results?

Neel Shah, MD: To date, no study has been able to take an apples to apples approach in comparing the effects of cesarean delivery rates across the world. Our project team at Ariadne Labs in Boston and at Stanford University went to considerable lengths to include more than 97% of all the live births in the world as part of the analysis, while also making the comparisons across countries as accurate as possible. We wanted to compare cesarean delivery rates at a single snapshot in time (2012), but current data was not always available. In these cases, we were able to make what we feel were very good educated guesses based on other knowledge we had of the country. We actually repeated the analysis for just the 74 countries with the highest quality data (derived from the OECD), and the findings were the same as the main analysis.

The best test, however is to just look at the two main graphs in the study, remove the lines, and remove all of the colored dots that represent the data we had to estimate. If you focus just on the black dots representing the directly observed cesarean rates you will see the same overall message: in many countries the cesarean rate is too low, and in many others it is too high.

SM: Can you explain why it is important to know where the delineation is when an increase in cesareans is no longer helping and is in fact harming the population?

NS: Generally speaking, when patients who encounter the healthcare system get harmed it is because we either did too little or too much. In the context of our study, some of the harm of doing too little is reflected in the mortality rates. However, the harm of doing too much is not evident in the study because by only looking at mortality, we are just seeing the tip of a very deep and wide iceberg.

Cesareans are major surgery and major surgery carries risks' in the United States, complications such as severe hemorrhage, organ injury, and sepsis are three times more common with cesareans compared to normal vaginal births. In countries that lack robust blood banks and other resources for safe surgery the risks are considerably higher. It is also important to keep in mind that childbirth is rarely a one-time event. We (obstetricians) are the only surgeons to repeatedly cut on the same scar over and over again, compounding the risks each time. This can lead to a dangerous condition called placenta accreta, where the placenta becomes fixed within the scar tissue and does not detach properly. In these cases women can, and in many cases do, bleed to death.

SM: It has long been clear that in low resource countries, the cesarean rate is too low and mothers and babies are dying due to the lack of surgical options that save lives when needed in higher resourced countries. What changes need to happen to reduce the mortality rate in newborns and mothers in those places where a low cesarean does more harm than good?

NS: Our study examined the association between cesarean rates and mortality but we were careful to note that it does not directly reveal the causes of mortality. What it may indicate is that some countries with cesarean delivery rates lower than 19% may benefit from greater investment in the safety of mothers and childbirth. At the margin, this does not necessarily mean they need to do more cesareans. It could also mean they need to invest in everything from better nutrition to improved infrastructure.

SM: 'Risk adjusted cesarean delivery rate' - can you explain this term? How can a risk adjusted cesarean delivery rate be used to calculate or determine a safe cesarean rate for different countries or even within a single country?

NS: There are a number of factors that we know increases the risk of a mother needing (and benefiting) from a cesarean (for example having twins or a breech baby). Although our study did not measure clinical factors, risks for cesarean at the clinical and system level can be used to calculate an 'expected' cesarean rate, which can then be compared to the 'observed' cesarean rate in order to see how much it is off by. This is what we usually mean by 'risk-adjusted.'

SM: This research looks at the relationship in maternal and neonatal mortality rates with the cesarean rate. In the discussion, you and the other authors speak to the importance of examining morbidity rates (both short term and long term) because there may be additional health benefits or burdens as a result of a cesarean rate change. Can you provide a little more detail about this line of thinking?

NS: Cesareans are designed to be a life-saving surgery but often we are also trying to prevent other types of morbidity - ranging from cerebral palsy in the newborn to birth trauma in the mother. This is one of the reasons why our findings should not be used to suggest that 19% ought to be the new target rate.

SM: This new research is taking a big picture look at the cesarean rate of the 194 countries belonging to the World Health Organization. What this information doesn't do is tell us what is happening within populations of women within a single country. How might one go about looking at that nuance of the 'proper' cesarean rate?

NS: To look at this in a more nuanced way you need patient-level data to better understand both patient risks and preferences. You also need much more data about the providers and the systems around the providers. In the United States, one of the biggest mysteries is why cesarean rates vary so much across hospitals. As it turns out, patient risks and preferences explain very little of the variation. In fact, the hospital a woman chooses may be her biggest risk factor for getting major surgery...and we don't really understand why.

SM: How can countries that need to raise the cesarean rate best tackle that? What specifically needs to be done?

NS: It is hard for me to speculate about this - I'm sure it depends on the country. Relatively few of the countries in our study reported data on the presence of skilled birth attendants and adequate facilities, but in much of the world this is clearly a major barrier. In South Sudan the cesarean rate is just 0.6%.

SM: It seems like one of the take-aways from your study is that different countries have different levels of optimal cesarean rates, based on a variety of factors? It is not a one-size fits all measure. Can you explain a bit more?

NS: I wouldn't call that a take-away from the study, but I completely agree with you that this is true at a country-level and at just a hospital-level. There are many things we measure in healthcare where we know the target number. Take maternal mortality for instance. The target number is zero. For cesareans the target depends, and you can only decide whether a cesarean was necessary on an individual patient level. And even then, it is hard.

If I do a cesarean and the baby comes out pink and screaming I think, it's a good thing I did a c-section. And of course, if the baby out blue and lackluster I still think it's a good thing I did a c-section! That being said, in the United States it appears that about half the cesareans we do may be avoidable in hindsight. Getting to perfect may be hard but there is tremendous room for improvement.

SM: What type of research should follow this study to help us get a solid understanding of what the optimal cesarean rate should be?

NS: In my opinion, cesareans will remain discretionary decisions for the foreseeable future. What I mean by this, is that whether or not to intervene comes down to a game time call, based more on art than science. Pregnant women understandably don't like to be experimented on and so the truth is that even in 2015, we know very little about what 'normal' labor should look like. The clinician just has to decide, is the baby too big? Is the pelvic too narrow? Is the uterus contracting strongly enough?

This is not a defeatist position however. I became an obstetrician because I was inspired by midwives and doctors who are extremely skilled at making these decisions. The trouble is that these clinicians are often hampered by the availability of resources and other aspects of the environment around them. In my own research, I focus on designing and testing systems of care that enable rather than hamper clinicians in making the best choice for the women in front of them.

SM: This research is considered controversial by some and speaks to a highly charged topic of issues around cesarean rates in general. Given the national recognition that the cesarean rate is too high in the USA, and with ongoing work happening here to reduce this rate, what are some challenges in having this research receive the appropriate recognition and not sending the wrong message.

NS: Part of the reason that childbirth is so charged is that it is a deeply personal endeavor - and so it is hard not to overlay our own subjective experiences onto any conversation about it. In some parts of the world cesarean rates are too low, and in some parts they are too high. The same is true in the United States'there are hospitals in our country with c-section rates of 7% that I seriously question the safety of. There are also hospitals with c-section rates of 70% that I have safety concerns about as well.

SM: How should a childbirth educator or other birth professional respond when a student tells them that they read a news article that says higher cesarean rates are better?

NS: I would ask them what they mean by better? From who's perspective? Everyone who has brought home a baby knows that caring for a newborn is hard work. It is much harder with a 12 centimeter incision. Whether or not that incision is worth it truly depends.

SM: How did this research come about? What is the history and development of the research idea?, Can we expect this to be updated routinely?

NS: This project was led by a surgical oncologist named Alex Haynes, and a group of his surgical colleagues (including Atul Gawande) who played an important role in helping the WHO quantify the global volume of surgery-as it turns out we did not have this estimate until very recently. The interest in cesareans came from the fact that it is by far the most common major surgery performed on human beings, not from a specific interest in childbirth. I was actually the only obstetrician on the team.

That being said, the lead author George Molina is a surgical fellow who is married to a an obstetrician who shares his interest in global health. He marshalled the paper through an extensive, year-long review process before it was ultimately published. I hope we do get to update this in the future but it may depend on whether we can recruit George to take-up childbirth research full time

SM: Were these findings what you expected? Were there any findings that surprised you?

NS: To me the most remarkable finding is that we did not see benefits to cesarean rates above 19%, and yet there is a long tail in the graph representing the many countries with cesarean rates that are considerably higher. For all of us who want to see more sensible use of interventions in childbirth, the clear message is that we have a lot of work to do.

About Neel Shah, MD, MPP

Dr. Neel Shah, MD, MPP is an Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, and associate faculty at the Ariadne Labs for Health Systems Innovation. He is an expert in designing, testing, and spreading system interventions that improve the safety, affordability, and experience of patient care. As a general obstetrician-gynecologist at Beth Israel Deaconess Medical Center, Dr. Shah cares for patients during critical life moments that range from surgery to primary care to childbirth.

Prior to joining the faculty, Dr. Shah founded Costs of Care, a global NGO that curates insights from clinicians to help delivery systems provide better care at lower cost. He is listed among the '40 smartest people in health care' by the Becker's Hospital Review, and has been profiled in the New York Times, the New England Journal of Medicine, and other outlets for his efforts to expose how low value care can harm patients.

In 2015, Dr. Shah co-authored the book Understanding Value-Based Healthcare (McGraw-Hill), which Don Berwick has called 'an instant classic' and Atul Gawande called 'a masterful primer for all clinicians.' He is currently a member of the National Advisory Council and Chair of Innovative Payment and Delivery Systems Workgroup for the National Partnership for Women and Families.

Other selected resources/work of Dr. Shah

I'm an OB-GYN. I'm not sure every baby needs to be born in the hospital - Washington Post

Moving Beyond the Cesarean Section - video

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