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This illustration depicts a mobile hanging over an infant’s crib. In addition to some traditional playthings, this mobile’s hanging elements hint at the delicate balance of issues to be considered by expectant parents and healthcare providers in whether to attempt a vaginal birth after a prior cesarean delivery. No permission is required to use the image. Please credit “Bonnie Hamalainen/NIH Medical Arts.
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NIH Consensus Development Conference on
Vaginal Birth After Cesarean:
New Insights

March 8–10, 2010
Bethesda, Maryland

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Press Telebriefing
Wednesday, March 10, 2010 - 2:00 pm EST

OPERATOR: Good afternoon, ladies and gentlemen and welcome to today's conference call, Vaginal Birth after Cesarean: New Insights and Health. All lines have been placed on a listen-only mode and the floor will be opened for questions and comments following the presentation.


If anyone should require assistance throughout the conference, please press star zero. At this time, it's my pleasure to turn the floor over to your host Kelli Marciel. Kelli, the floor is yours.


KELLI MARCIEL, COMMUNICATIONS DIRECTOR, OFFICE OF MEDICAL APPLICATIONS OF RESEARCH: Good afternoon and welcome. To start out, I apologize for our slight delay in getting started and we appreciate for your patience. Welcome and thank you for joining us today for this telebriefing to discuss the findings of the NIH Consensus Development Conference on Vaginal Birth after Cesarean: New Insights, held at the NIH in Bethesda, Maryland this week, Monday through Wednesday.


I'm Kelli Marciel, communications director with the NIH Office of Medical Applications of Research or OMAR. This conference was presented by OMAR and the Eunice Kennedy Shriver National Institute of Child Health and Human Development as part of the NIH Consensus Development Program. It was co-sponsored by several other NIH institutes and other components of the U.S. Department of Health and Human Services.


For those of you who may not be familiar with the NIH Consensus Development Program, there are a couple of points that are important to bear in mind. The members of this consensus development panel were selected for this task because they have expertise in – excuse me, relevant fields including obstetrics and gynecology, urogynecology, maternal and fetal medicine, and the list goes on, and because they are viewed by their peers as highly skilled in critically examining the scientific evidence.


The panel members came to this process free of academic or financial bias regarding the conference topic. As conditions for their inclusion on the panel, they must hold no financial interest in an entity that could be benefited or harmed by the conference findings. The panel members have spent the last several weeks reviewing published literature and have spent the last two days absorbing the testimony of experts in the fields and the conference audience.


Following the conference presentations and discussion, the panel met until late last night in executive session to weigh the evidence and prepare their statement answering six key conference questions. The panel members performed this task on a volunteer basis. The NIH covers their expenses for traveling to the conference but they are not compensated for their time.


It's also important to recognize that the panel issues this statement as an independent group. Their statement does not represent a policy or position statement of the NIH or the federal government. The panel's draft statement marked 4:41 this morning has been posted to the media resources page. You could view the conference online at consensus.nih.gov.


The panel chair presented this draft to the conference audience at 9 o' clock this morning followed by a discussion period to allow the audience to offer comments on that draft. The copy of the statement you should have received via e-mail includes a roster of the panel members, many of whom are here to answer your questions as part of this telebriefing. The panel met in executive session again between 11 am and 2 pm this afternoon to discuss the comments that they received in the open session this morning.


The revised draft will be posted to the Consensus Development Program Website later today. A few procedural points before I turn things over; Dr. Cunningham, our panel chair, will provide an overview of the panel findings after which there will be time for questions which may be answered by Dr. Cunningham or another member of the panel.


The telebriefing will end promptly at 3 pm, if not sooner. Press star-one to queue up to ask your questions. A moderator will recognize you in turn and un-mute your line to allow you to pose your question to the panel.


Finally, only members of the media are permitted to ask questions during this telebriefing. Other interested parties have been welcomed to listen in as well but will not be recognized to address the panel with questions.


And with that, I'll turn things over to our panel chair, Dr. F. Gary Cunningham, Beatrice and Miguel Elias Distinguished Chair in Obstetrics and Gynecology at the University of Texas, Southwestern Medical Center at Dallas. Dr. Cunningham?


F. GARY CUNNINGHAM, UNIVERSITY OF TEXAS, SOUTHWESTERN MEDICAL CENTER: Good afternoon. My name is Gary Cunningham and I'm the panel chair for the consensus conference that Kelli has so adequately outlined it for you. The inception of this conference began over a year and a half ago and a lot of work has been put into this by many people in this well-orchestrated attempt to look at data that tell us where we are in relation to the position of so- called VBAC, as you know is Vaginal Birth After Cesarean delivery, versus elective repeat cesarean delivery. And this was stimulated by the obviously well-known, rising cesarean section rate overall in this country as well as the world.


And we know that the primary cesarean or one for the first time will beget other cesareans and this has created some problems. Another problem has been the voice of many women who have bemoaned the fact that they have not had access to care where a trial of labor can be offered as an alternative to an operative delivery. And this of course is mirrored by the fact that the VBAC rate in the United States has diminished in the last almost 15 years from 30 percent to about 10 percent with the market change.


So we were commissioned then to look over this mountain of data which we did. We've looked at literally thousands and thousands of pages of evidence. We've looked at hundreds and hundreds of pages of peer-review research and we have tried to come to the state-of-the-art conclusion of where we stand right now and what we can do to provide better resources or better access to the women of whom we speak.


The conclusions that we reached are not – they're not of guidelines. I think we have to make that quite clear that these are not guidelines. These are considered a consensus report and not guidelines.


And what we found was that the use or the employment of a vaginal delivery after cesarean with the trial labors is certainly a safe alternative for the majority of women who've had one prior cesarean section, assuming it is the so-called low transverse variety. We looked at factors that would prohibit these women from having access to this decision or this choice and we concluded after that that there are several major reasons why this access has been blocked or at least diminished in many places.


We would – I can quickly run over those. The effect of that, the number of hospitals offering trial labor is diminished because of the perceived good and bad outcomes that accrue to either the mother of the fetus. Many of these outcomes can be quite catastrophic. And even though they're relatively uncommon when they occur, they're quite devastating to, obviously, the women and her family, as well as to the medical personnel for whom are caring for them.


And some of these, we to addressed public policy. We addressed the lack of access to care in certain areas because of monetary considerations. The fact that some areas are very wide because they're in geographical spread areas and whatever, and some of these will be insurmountable. But we hope that some of the recommendations will cause some of these to be improved.


For example, we found that there is a medical legal consideration that puts up some of these barriers. This is generated by the rather large wards that occur only rarely with the bad outcomes to babies. And the fear of this is has driven a lot of providers out of the business or the practice of offering VBAC because of those rare but catastrophic complications. We're concerned about some barriers, and perhaps, some professional societies have made some – have made some very good, but sometimes impossible to follow, guidelines.


And this has put many hospitals on a position of having to close to their access to these types of procedures, with catastrophic outcomes. So with that in mind, I would ask you to look at your handouts and ask our panel who has worked unbelievably hard the last three or four months to – for their opinions on various and sundry subjects.


OPERATOR: Thank you. The floor is now open for questions. If you have a question, please press star one on your telephone keypad at this time. If you're using a speaker phone, we ask that while posing your question, you pick up your handset to provide favorable sound quality. Again, ladies and gentlemen, if you have a question or comment, please press star one on your telephone keypad at this time.


Please hold a moment while we poll for questions. Our first question is from Brenda Wilson from the NPR, please go ahead.


BRENDA WILSON, SCIENCE DESK CORRESPONDENT AND EDITOR, NATIONAL PUBLIC RADIO: Yes. Hello. One thing that is not clear to me is whether you recommend that ACOG change its language about having anesthesiologists, surgeons, the full panoply of, you know, medical personnel on hand before a VBAC can be performed or within what time period do they need to be on hand?


That's not clear to me. Is it immediate? ACOG today seemed to indicate that you hadn't changed or you supported their position.


CUNNINGHAM: Well, that's sort of yes, sort of no. What we recommended is we looked at the guidelines posted by the American College of OB-GYN as well as the American Society of Anesthesiologists who has, you know, issued to joint statement about the "immediate availability" just, I think, in the past few months and it reiterated the immediate availability which, according to the statistics of ACOG, has definitely been a factor in decreasing the access to care for many women. We looked at the evidence and we found no good evidence that such a rule had changed any of the outcomes of interest. But that doesn't mean that it doesn't apply; it just means that there's no evidence to support that and it is a crippling (INAUDIBLE) many hospitals and physicians and it, therefore, is a big driver of this problem at hand.


What we did, and after looking at everything and listening to testimony by a number of people who are experts in this particular area, anesthesiologists as well as obstetricians, as well as hospital administrators, what we did is we recommended that these organizations reassess their requirement relative to other obstetrical complications. In other words, this policy is made for just one particular instance in which a bad outcome is not very common. Yet, you have to follow the rules for all the 100,000 of patients who deliver, and maybe there's only going to be 10 catastrophic outcomes out of 100,000, which kind of outlines what the problem really is.


So, we just asked them to reassess those guidelines in light of the lack of any supporting evidence but we also said, you know, you probably need to look at other obstetrical problems that may or may not require immediate obstetrical and anesthesia help.


WILSON: And let me just be clear about something you said. You looked at the evidence. You found no evidence that this rule or this guideline, you know, to have, you know, immediate access that it had an effect or that, you know, that it changed outcomes?


CUNNINGHAM: Well, there's no data either way, there's no data to indicate that it didn't work or it didn't improve things. There's no data to indicate that it made things worse. So, our request is that they reassess that.


EMILY LUKACZ, ASSOCIATE PROFESSOR, CLINICAL REPRODUCTIVE MEDICINE: This is Emily Lukacz from San Diego. I think the only thing that these guidelines that we can clearly see an association, not necessarily a cause and effect, but a decrease in access for women who want have a trial of labor. It's the only, from expert testimony, but not from scientific evidence.


MARCIEL: Does that cover your questions, Brenda?


WILSON: Yes. I'm sorry. Thank you.


MARCIEL: Thanks. I think, next, we'll hear from Susan Jenkins with Big Push for Midwives.


SUSAN JENKINS, STEERING COMMITTEE MEMBER AND LEGAL COUNSEL, BIG PUSH FOR MIDWIVES CAMPAIGN: Thank you very much for taking my question. And I would like to address the one attorney who is on the panel and I believe that is Ms. Zimmet from Georgetown University. Is she present right now?


SHEILA ZIMMET, ASSOCIATE VICE PRESIDENT, GEORGETOWN UNIVERSITY: Yes, I am.


JENKINS: Ms. Zimmet, did the panel take into consideration any of the extensive legal and ethical literature on the issue of informed consent? Because my understanding this morning, and to the great disappointment of most of the people who are present in the audience, the panel did not take a position affirming that pregnant women should be considered persons with constitutional rights the same as any adult person. And I'm wondering that, even though, yes, I agree, there's presently few, if any, appellate-level decisions other than in re A.C. from the District of Columbia, addressing this issue specifically in the context of pregnancy, that case did come out squarely in favor of informed refusal, always, for the mother. But there is extensive law review writing in this area; is the panel aware of the extensive and very much pro–informed refusal literature among attorneys and law professors on this area?


ZIMMET: Well, yes, we did have conversations in that area. We focused on informed consent as a factor that influenced practice and patterns, and access to trial of labor. We didn't see it as our task to resolve that issue and focused on that issue. We think we need to look at the informed consent issue and see what improvements there can be in the communication between provider and patient; any tools that can be provided and developed to answer those issues, but we recognize that the medical legal issues involving informed consent, constitutional and ethical issues, really are issues that are answered in a varied fashion in different states. And we certainly weren't in a position to answer them at this consensus panel.


JENKINS: So, in spite of Dr. Lyerly's ethical presentation yesterday, the panel is unwilling to affirm the ethical necessity of recognizing that a woman has an absolute right to informed refusal of the surgical procedure that may cause harm to her?


LARRY MCCULLOUGH, DALTON TOMLIN CHAIR IN MEDICAL ETHICS AND HEALTH POLICY: This is Larry McCullough. I'm the ethicist on the panel.


JENKINS: Yes.


MCCULLOUGH: They claim that the right to refuse is absolute is a controversial claim. It's not at all settled in the law or in medical ethics but in – even if it – and that controversy which is considerable is way beyond the scope of this group. We did however strongly emphasize the need for an evident-based, unbiased approach to the informed consent process, to make sure that women eligible for trial of labor would be informed about that alternative and get the information they need about it, to make their own decisions for themselves. And so, there is a strong emphasis on the centrality of informed consent of – in our conclusions.


JENKINS: Dr. McCullough, just one quick follow up question, if I may, on that. The conclusions that are reached in the draft, at least, the draft opinion that we saw this morning indicates that the commit – the position of the, you know, committee is that only where it's considered medically reasonable, quote, unquote, whatever that means, is there – does – would the woman have the right to refuse. And that, the definition of medical – medically reasonable is – there is no definition for medically reasonable.


MCCULLOUGH: Well, actually there is. And the concept is it's the idea is when the alternatives are roughly medically equivalent. What we said, is that shared decision making should be followed where the tradition refrains from making a recommendation and really helps the woman make a decision that reflects her values and preferences which is what the goal of the informed consent right.


JENKINS: Right. What if her values and preferences is to say no...


MARCIEL: Susan?


JENKINS: ... at the end of all that?


MARCIEL: Susan, I'm sorry, this is Kelli, we've got a lot of people waiting in the queue and we have limited time.


JENKINS: Oh, so, you're going to dodge the issue and that's what I'll report to my readers. Thank you.


MARCIEL: Please feel free to queue back up and if there's time at the end we'll be happy to discuss that further but we're going a little bit far afield from the panel's charge.


JENKINS: OK, I would suggest to the other reporters that they check with some of the people on the audience on that issue, including National Advocates for Pregnant Women.


MARCIEL: Thank you. Next we'll take Denise Grady, from the New York Times.


DENISE GRADY, WRITER, NEW YORK TIMES: Thank you. I have a couple of questions that I'll go through, one is, at the – during the common session, Dr. Spong (ph) asked the group if you would make a specific explicit statement in the report that this – that VBAC is a safe option for many women. So, I'd like to know if you do plan to amend the report in the way that she suggested. The next question I'd also like to ask about, why the wording is – just that you were asking the professional groups just to re-assess the requirement. Why do you stop short of saying something stronger, like, change it or loosen it up or something like that? Why do you – why is it such a measured approach to that question? And why not more of a recommendation about who's a candidate and who's not? Thank you.


CUNNINGHAM: This is Gary Cunningham. I'll address the part about the statement and the revision of the policy. Without data this committee is not any better – not in any better position to mandate a management practice any more than we had thought of the current role was by the professional societies. And remember, I've couched this – first this interview by saying that we do not write guidelines, we do have recommendations, we do have conclusions. And we feel that both of these societies are obviously they're going to revise the – I mean, they're going to consider revising their guidelines. But bottom line is we can't make them do it and if that process is necessary then the usual day of business will take care of it.


Now, regarding Dr. Spong's (ph) remarks, those were entered into the final conclusion of – to represent, essentially, what she said, I don't recall the exact wording.


MARCIEL: And I'll just remind folks on the line that that revised draft will be up later today at consensus.nih.gov, so you can check on that there.


PETIT: Yes, this is, Nancy Petit, OB/GYN; Wilmington, Delaware. Just to expound on that last comment, we did appreciate what Dr. Spong had to say, and it was the consensus of the group that given the safety of trial of labor and the majority of women with a prior low transverse cervical cesarean delivery that we believe that many women should have the opportunity to give it a try.


MARCIEL: Does that answer all your questions, Denise?


GRADY: Yes, it does. Thank you.


MARCIEL: Great, thank you. Next, we'll hear from Bridget M. Kuehn. JAMA Medical News


BRIDGET KUEHN, WRITER, JAMA MEDICAL NEWS: Thank you for taking my question, I appreciate it. It seems that there may be a bit of a trade-off, if you loosen the requirement or – req or – if ACOG and these other groups decide to loosen the requirement of having a physician immediately available, those minority of women who do experience a catastrophic event, what will be the medical implications for them? And what are the legal implications for doctors in that case, if there is not a doctor immediately available to respond and there's a delayed response?


CUNNINGHAM: Well, you could say the same thing, if the patient was having labor at the – let's say, at a birthing facility or outside the hospital when their doctor, anesthesia personnel were not there. So, if you're going to apply the rule to the hospitals theoretically, you should provide it to the whole providers who are giving obstetrical care. The other thing comes back to be careful what rule you revise because you may make things worse.


For example, the American College of Anesthesiologists may well conclude that, "Hey, you're probably right. This could happen to anybody in any labor. Why are we concentrating on VBAC?" So that's demand 24/7 coverage for any hospital that does O.B. And then you go release the access to care, it goes down even lower. So, you know, we have to consider all these things. And these are the – given the data we had, these are the strongest recommendations we could make.


TEKOA KING, CNM, M.P.H., FACNM, U.C. SAN FRANCISCO: This is Tekoa King from U.C., San Francisco. Thank you for a very good question. One of our suggestions is going to be that we have more work and study looking at the population of women who have had a previous caesarian section to better characterize those within that group that are low-risk, maybe medium-risk and high-risk for the outcomes that you've brought up. And there are certain trends that this may very well be information that can help mitigate the problem that you suggested.


KUEHN: All right. Thank you.


EMILY LUKACZ, MD, UC SAN DIEGO MEDICAL CENTER: I have one more. This is Emily Lukacz again from San Diego. I'm a urogynecologist. I think one of the main goals of our panel was to be able to provide individual women and practitioners risk rate, not relative risk, not a twofold increase or three-fold increase but absolute numbers. And part of our consensus document has those absolute numbers relative to usual causes of death, death in the reproductive range, infant mortality, SIDS mortality, so that you can actually look at the numbers per 100,000. And each individual woman will have different preferences and different levels of risks that they're willing to accept in order to have an experience that they are invested in.


MARCIEL: Does that cover it for you, Bridget?


KUEHN: Yes, thank you very much.


MARCIEL: OK, thanks. Next, we'll hear from Lauren Neergaard with the Associated Press.


LAUREN NEERGAARD, ASSOCIATED PRESS: Hi, thanks. I wondered if you could address what's the right balance here because we did have this big swing from nearly 30 percent VBAC rates 15 years ago. Was that about right? Do we have an idea of what is about right, where we should be?


CUNNINGHAM: This is Gary Cunningham again. We labored with that for a long time, no pun intended. We – nobody knows what the cesarean rate is for anybody. There are ballparks that have been suggested. The National Consortium of Healthy People 2000, I think, recommended that we shoot for a primary cesarean rate of, I think, 15 percent at about this time. And we've obviously exceeded that, I think.


And if you've seen the handout, the incidence of primary cesarean section is higher than 15 percent. As I said before, there's no doubt that the primary cesarean delivery rate drives the repeat rate because if you look at the graph in the handouts or the – I don't know what kind of materials you guys have, but the graph from the National Center for Vital Statistics shows that as the number of VBACs goes down, the number of repeat section goes up. Well, that's easy to say, "Yes, we can say that." But – so it's a function both of the primary cesarean rate as well as the decreased VBAC rate. I'm not dodging your question about what the ideal cesarean rate is because I don't know any more than anybody else knows. So, there are a lot of people who will tell you their opinions on it but, I don't really have one, especially with this particular group, we just know that it could be higher but how high; I mean, I'm talking now about the trial of labor, right? It could be higher with more vaginal deliveries and less cesareans, but there's going to be a tradeoff, there's going to be more – more complications for the fetus and well, maybe also for the mother.


NEERGAARD: And to follow up on that, can you talk a little bit more about who's the candidate? I mean, you've said a couple of times that it has to do with the low transverse section, which I think, is pretty much all people do now, but in that larger group, is there a way to tell who would be a better candidate for trial of labor or not?


MARILYNN FREDERIKSEN, M.D., CLINICAL ASSOCIATE PROFESSOR, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, FEINBERG SCHOOL OF MEDICINE:
This is Marilynn Frederiksen, Northwestern University. I think one of the problems that we have was in the data there wasn't an approach that we could uniformly use to figure out who was the best candidate. There are multiple screening tools that work as a population-based data in our very – and have been validated but one didn't get to the individual. They don't have the power to really predict who will succeed and who will not. There are different approaches as to evaluation of risks and in our critical gaps in our recommendations, we wanted evaluation of some of these tools to actually better delineate the patient who would be successful for trial of labor.


CUNNINGHAM:
Look, let me comment. I'm sorry, let me – this is Cunningham again, let me follow up on that, too. There's a – some confusion about, whether these – these assessments apply to the trial of labor being a success and that really says nothing to the bad outcomes except that we know that – unsuccessful of trial of labor leading to cesarean, does have a worse outcome than a patient who has an elective cesarean.


What we – we can only say, about some of these risk factors that your chances of having a successful VBAC or a little bit greater or less or whatever, without putting a number on it, but the other thing that we found that was important is– there's no risk assessment tools or methods to find those women who had more likely to have the horrible complications.


And there's a pretty good data on that, that the women who had the worse complications are the same one's at the – they would be delivering either at the birthing center or in a hospital. So, there's a – that's another one of those dark gray areas in the data. And we recommended that the people look at this, I mean, the thing that causes the bad things around here; number one, are ruptured uterus, with the woman suffering from a loss of her uterus, hysterectomy, multiple blood transfusions, and you know, perhaps even dying from the complication, and the fetal complications are early, early rupture separation of the placenta before the baby can be delivered outside and the baby's severely brain damaged.


And those are the two things that if we had a risk assessment to predict those, we would go into business and become famous as clairvoyants but unfortunately there's no way you could pick these out. So, what we've done is we've said, "OK, these are the patients who can probably be safely offered or offered trial of labor where it'll be relatively safe. You'll have the lowest complication rate. We're not recommending any of this for patients who have complications, patients with two incisions, we didn't mention that. These are all patients who have one prior low transverse cesarean incision and that's it.


LUKACZ: At term.


CUNNINGHAM: And at term, excuse me, yes, at term. But because that's where the data appears to be the most robust. And Carol, we don't recommend it for patients who have medical problems, patients who come in with breeches, patients with twins and things to that nature.


So, that leaves about 70 to 75 percent of the patients who would be eligible to at least consider a trial of labor.


MARCIEL: OK. Lauren, I'm going to ask you – so that we can accommodate a few more questions before our time runs out. I wonder if we can table this until we get through a few more and then maybe we can revisit it if there's time.


NEERGAARD: That actually answered it. So, thanks.


MARCIEL: Great. Thank you. Next, we're going to hear from – and I'll give the panel a chance to weigh in again later if they want to clarify once we entertain a few more questions. Next, we're going to hear from Pat Anstett with the Detroit Free Press.


PAT ANSTETT, DETROIT FREE PRESS, MEDICAL WRITER: Yes. Thank you very much for taking my questions. I need some clarification. I had my own question and then Dr. Cunningham just said, "We don't recommend it for patients with twins, medical problems and so on." I assume he was talking about VBAC and if that's the case, it leads to my – here is my question, which is, many women end up with a primary repeat C-section; if they are older, have a chronic disease or overweight or have a multiple gestation pregnancy, should any of those women – is it safe for them to consider a VBAC?


Women are going to run into this, doctors say this all the time, what's, you know, if a doctor says this to a woman, "You might end up with a C-section because you're 40 years old" or whatever, what's the response? What does a woman need to know about the evidence linking these conditions, medical conditions, to problems in a pregnancy and delivery?


CUNNINGHAM: Well, we have to – this is Cunningham, again – we have to say again upfront that we – the limited amount of good data is restricted to the – the quote low risk patient. There's barely enough data say for example to say, you know, it's safe to deliver twins because we don't know for sure if the complications are, let's say, doubled or, for example, because there's two babies. I don't know if that would double the complication rate there or not.


But intuitively, I think that in obstetrics, you know, that any of these complications are bad enough without a trial of labor and...


ANSTETT: What about age of the woman, Dr. Cunningham? How does...


CUNNINGHAM: Well, I mean, it has to...


ANSTETT: There are a lot of older women having babies and they want to know if it's safe to have a VBAC or not?


CUNNINGHAM: That's a very good question and it's going to be more common. In the last statistics I saw showed that the 10 percent of the deliveries in this country were to women who are over the age of 40. And there are a multitude of problems that ensue from that, most of them are – can be handled but as far as a categorical rejection, age 40 would not necessarily be one.


(INAUDIBLE): similar question. When you look at older age women, they do have a higher rate of caesarian section overall. And – and that maybe looking at all comers – when we looked at the success rate of VBAC, that did seemed to be some data supporting age related – Dr. Grobman presented data that on population base that they have less success rate. So, it's a factor.


ANSTETT: They have less success but did they have more problems? I'm looking at that as two different things.


(INAUDIBLE): We don't have that data.


ANSTETT: You don't have that data. So, for now, women who fall into all these other categories don't have good guidance on whether or not they should go one route or the other, it sounds like.


CUNNINGHAM: Well, it depending on how it looks, let's just take age with you. It's not a categorical, un-variable or whatever you want to call it. Older women have bigger babies. And that's a factor in recommending against a trial labor, if you have a large baby. Older women have a higher rate of dysfunctional labor that requires the use of oxytocin, augmentation, or induction, which has been suggested to have an effect on uterine rupture.


It increases the incidence of hypertension. So, now, you have a woman who's potentially hypertensive, who has, you know, whatever – and, well, diabetes. I'm reminded by Dr. Fredrickson that diabetes obviously accrues with age. It's a disease that's, I think, 4 percent in the obstetrical population at age 40 whereas it's only one percent at age 20.


And diabetic women have problems as, you know, you can surmise. Plus, they tend to have big babies, too. So, you have to look at the whole picture. And our data doesn't preclude those other women from looking at a trial labor with their providers. It's just that we can't say, "Hey, they should be categorically offered," one, for the reason I just told you.


MARCIEL: Does that help out, Pat?


ANSTETT: A little. I was looking for more clarity to give to women today rather than saying they're, you know – but I'm sorry, I will stick to what you're willing to stick with. I'm not trying to push you somewhere but women get – I just spent time in all this reporting this. You know, I'm talking too much here so let's move on.


MARCIEL: Thanks. We actually...


CUNNINGHAM: Let me say...


MARCIEL: Sorry.


CUNNINGHAM: This is an important – this is an important concept and we're – what we're saying is that you have to take the – you'll have to tell me about an individual patient and maybe one of us could give you a recommendation. But just to categorically say older women can have, say, trial labor, we can't say that. Not only can't, but we won't.


MARCIEL: We have one...


ANSTETT: But lots of doctors conversely are saying the opposite which is, if you're older, you probably shouldn't have trial labor. They might not come right out and say it but that's what the result is.


MARCIEL: OK. Now, Pat (ph), we have one...


ANSTETT: Now, I'll stop here. Thank you.


MARCIEL: Thanks. We have one more panel member who's interested in weighing on this, Tekoa King.


TEKOA KING, ASSOCIATE CLINICAL PROFESSOR, U.C. SAN FRANCISCO: This is Tekoa King from U.C. San Francisco. Pat, it may help a little bit if you think first about the indication for the original caesarian section. There are some recurring indications and there are some non-recurring. So, for instance, the woman who has her first caesarian section because she has a baby in a breech position, that's not necessarily going to reoccur; she is not necessarily needing a caesarian section for all of her birth. And some of the other conditions that you've indicated, age or pre-existing medical condition, the issue really for them is not so much VBAC versus not VBAC but what is their medical condition at the time that they are at term and ready to give birth.


If there are other indications for medical care, it should be provided to them. That needs to be factored into their decision about mode of delivery. The other thing is that with regard to people who don't have any other conditions that need to be factored in, we have some preliminary data that you can categorize women as low-risk, medium-risk, or high-risk for problems with the VBAC. And that that's the data that we've recommended we really need to get a lot more of so that that can be of value to settings where there aren't – maybe don't have quite as many resources or for women like you were talking about.


LUKACZ: Can I just make one more comment on that? This is Emily Lukacz in San Diego. I think that the point is not that we are just trying to say that only certain women should talk to their providers about VBAC.


I think all women who've had a prior caesarian delivery should talk to their providers about VBAC, and reassess what their individual risk and what their level of risk acceptance is. And there aren't going to be exact numbers. This conference tried to provide some numbers on the big outcomes but the small outcomes are very individual and very dependent on what each individual values both provider and patient values are.


MARCIEL: I hope that rounded that out for you, Pat. I think we're going to move to Shari Roan of L.A. Times.


SHARI ROAN, L.A. TIMES: Thank you. I wanted to ask the panel about what is the level of concern about the risk of repeat caesarian sections such as these complications with the placenta as we see more women have two, three, maybe four caesarian sections, if their growing concern that that isn't a very good alternative either and perhaps, more VBAC should be tried just to avoid that kind of situation.


LUKACZ: Absolutely. This is Emily Lukacz again in San Diego. That is a critical aspect in counseling a patient regarding her choice of mode of delivery at the time of her second pregnancy, or pregnancy after a C-section. We looked at the evidence and it appears that from national statistics, approximately 30 percent of women will have three or more children during a lifetime.


So that means in 70 percent, this question is probably not as important. But, you know, it was brought up at the conference that not everybody can necessarily plan having subsequent delivery. So it is a very critical aspect of the counseling process. Certainly anyone planning multiple or higher orders of pregnancies with each increasing – each caesarian section, there is a market increase in complications related to repeat caesarian sections whether that's placental abnormality, either the placenta being in the wrong position, covering the cervix, growing into the uterus, these oftentimes result in hemorrhage needing transfusions, resulting in hysterectomy sometimes, which would clearly have a major impact on somebody's future childbearing.


So, we provide those very discreet numbers. Although based on fairly low evidence, not large studies there – because these rates occur fairly infrequently. But we try and give those numbers very specifically for each subsequent caesarian delivery so that women can make decisions with their providers about what the best choice for delivery is.


ROAN: Thank you, Dr. Lukacz.


MARCIEL: Thanks. Next, we're going to hear from Frederick Jolsen (ph) with Reuters.


FREDERICK JOLSEN (ph), REUTERS: Yes, hi. I was wondering in terms of safety. Could you tell me about how VBAC compares with first-time vaginal birth? Are they – are the risks similar? Hello?


MARCIEL: One sec.


FREDERIKSEN: If you think about the catastrophic events including uterine rupture...


JOLSEN (ph): I'm not really hearing this.


FREDERIKSEN: I'm sorry.


JOLSEN (ph): I can't hear you.


FREDERIKSEN: If you think about the catastrophic events, a uterine rupture...


JOLSEN (ph):
Yes.


FREDERIKSEN: ...with the trial labor, it has approximately the same incidence as catastrophic events of nulliparous women with respect to the outcome for the newborn. This is Fran Frederiksen from Northwestern. And we gave numbers in the report so that we have reference points to other events – that occurred at similar levels. So that is in the report.


LUKACZ: Can I just add to that? This is Emily Lukacz again. The risk of uterine rupture in a primiparous patient is limited to basically case reports within the literature and in Williams Obstetrics; that base background rate for uterine rupture, 92 percent of those occur in women who have already had a prior caesarian delivery; that means less than 8 percent or less would occur in a primiparous patient.


JOLSEN (ph): OK. Thanks. Could you please state your name again, the first one who answered? I didn't catch that.


FREDERIKSEN: Marilyn Frederiksen, Northwestern University.


MARCIEL: Did you get that this time, Frederick (ph)?


FREDERICK (ph): I did not, no.


MARCIEL: It's Marilyn Frederiksen.


JOLSEN (ph): OK, thank you. Thanks so much.


MARCIEL: Thanks. Next, we're going to hear from Sarah – we're only going to have time for a couple more callers. We have Sarah Wildman, Politics Daily.


SARAH WILDMAN, POLITICS DAILY: Hi, can you hear me?


MARCIEL: It's a little garbled. Can we try again?


WILDMAN: All right, can you hear me now?


MARCIEL: Not very well. I'm sorry, let me take one other and then if you'll queue up again maybe we'll get a better connection.


WILDMAN: OK.


MARCIEL: Sorry. Brenda Wilson, NPR.


BRENDA WILSON:
You know what, it's OK. I was, I was going to ask the person who asked the last – answered the last question to do it online because you're doing it in a – to the open room and I'm radio. I suppose or I can call, someone can call me later, that's all. It's just not working for me.


MARCIEL: Thanks. Sorry, we did but we had some audio trouble on the last call, I hope we're clearer now. We'll follow up with you by phone, Brenda. Sarah Wildman, Politics Daily, should we try again?


WILDMAN: Is that better? If it's the connection, I'll let it go. Is it at all better now? If I can, maybe make it fast. (INAUDIBLE). Is that any better?


MARCIEL: I'm sorry, we...


WILDMAN: You can't hear me.


MARCIEL: The operator is telling us it's your connection that's giving us trouble.


WILDMAN: OK, I already (INAUDIBLE). Thank you.


MARCIEL: Thanks. I think we'll pause a little bit and let anybody else who wants to queue up give them a chance. In the meantime, I want to remind everyone that, like I said, the draft statement is going to be up later today at concensus.nih.gov. Also if you follow the links from that homepage to the media resources page, you'll be able to access a playback of this call pretty quickly, the number for that is already up and shortly after conclusion of this call, that will be available. So if you came in late and missed anything you want to play that back, you'll have that option. Also a little bit later on, we'll have audio and text transcripts of that available online. I'm looking for anymore questions from the poll. I'm also going to offer the panel an opportunity if they'd like to make some closing remarks clarify anything they've said. We have a – Doctor Hogue.


CAROL HOGUE, EPIDEMIOLOGIST, EMORY UNIVERSITY, GEORGIA: Hello, I'm Carol Hogue, Epidemiologist at Emory University and I wanted to just emphasize something that was said earlier that pregnancy is something of a risky endeavor that women do suffer complications of pregnancy and their babies do have problems and fortunately these are rare. But they occur irrespective of mode of delivery and in fact for some delivery – some outcomes, cesarean delivery is more risky than any kind of vaginal delivery; be it after a C-section or – than it's first – in the first pregnancy; and in particular, the very rare, fortunately, experience of maternal death is higher for C-section irrespective of whether it's primary or repeat. And I think this is important for women and their maternity care providers to recognize, to understand, and to weigh.


One of the problems with the panel's considerations of this, is that sometimes in weighing those options, it's a tradeoff between making the pregnancy as safe as possible for the mother versus making the pregnancy as safe as possible for the baby, and it's in those trade offs and in the lack of really good information to give accurate and compelling information to the woman and her maternity care provider that we are more cautious in what we say then I think we would feel comfortable being if we – if we did have those data. Our research recommendations if implemented would go a long way to being able to answer those questions.


MARCIEL: Before we hear from more panel members, I want to give Sarah Wildman one more chance to see if we can get that audio.


SARAH WILDMAN: Hi. Is everything OK? Is that any better, right now?


MARCIEL: I'm sorry, it's not.


WILDMAN: Am I better? OK, I'm sorry. OK. All right, thank you.


MARCIEL: We'll try to catch up with you by phone after the briefing. Another panel member wanted to weigh in.


NANCY PETIT: Hi, this is Nancy Petit from Wilmington, Delaware. The other thing that we were able to identify both in review of the literature, as well as the opportunity to listen to the individuals that attended the conference, is that there is a true need for a better communication between the health care provider that is – that's providing the woman her pregnancy care, and the woman herself.


And we really felt that it was important to encourage that the health care provider – share with the woman first of all, what the capabilities were of the institution that would be participating in her delivery, the level of comfort that the health care provider had in terms of her identified risks, and it was also important that in return, that he really or she really take the opportunity to listen to what the pregnant woman had to say in terms of what her desires truly were. And again, if weighing all of the – the risks and the benefits hopefully between these individuals as well as any other family that are going to weigh into this, they could come up with a best plan that was, that was, I guess, suitable and meant the most to both.


MARCIEL: Hope that's helpful to folks, we're going to – oop (ph), we have another caller on the line, Kelly Brewington with the Baltimore Sun.


KELLY BREWINGTON, BALTIMORE SUN: Hi, sorry for this late question. I just want to understand something about the scope of this consensus report. Doctor Cunningham, you said that this report is not a set of guidelines but a consensus report. But what exactly does that mean? What kind of influence will this report have on the practice of VBACs that you hope?


CUNNINGHAM: What we would hope is that women who were interested in having a trial of labor will have better access to a safe trial of labor within a hospital is what we've – we would like to see happen.


BREWINGTON: OK.


CUNNINGHAM: The data indicate that hospitals are not able or willing to provide that service and that's closed the door – and no pun intended there either – has closed the door to a lot of women having a choice between the two. And that we – we're just hoping that by putting this data out there, after this exhaustive review, will prompt some people to look at the problem. This is a multi-faceted problem. It won't be solved by a small hospital in a rural county that's got 200 deliveries a year. It won't be solved by the big hospitals. It's got to be solved by public officials. It's going to be solved by, there's going to have to be discussion between doctors and lawyers, and business persons, insurance companies and many, many things before this problem is probably solved.


BREWINGTON: OK. Thank you.


MARCIEL: Thanks, Kelli (ph). Oh, we're almost out of time. We have another comment from the panel? OK.


WANDA NICHOLSON, ASSOCIATE PROFESSOR, CHAPEL HILL, NORTH CAROLINA: This is Wanda Nicholson from Chapel Hill. Just one comment that I think that, you know, we are able to, you know, say that there are a large number of women who will be eligible for trial of labor. But then, again, the most, rather, more important point is to ensure there is sound and good communication between maternity providers and their patients. So that there is a balanced discussion of potential benefits in both trial of labor or repeat caesarian delivery, and then in that fashion we could ensure appropriate and thorough informed consent to our patients.


MARCIEL: Great, thank you. I want to thank everybody who called in and everybody who's been listening in. I'll also thank the panel members for their time and encourage those of you who called in, that if you need any further assistance in covering the conference, please do check the media resources page for some of the resources we've described already. And certainly, if you have any additional needs or questions, please call me at 3014964819. And with that, I believe, we will sign off. Thanks everyone.


OPERATOR: Thank you. That concludes today's teleconference. Please visit us on the Web at consensus.nih.gov or e-mail us at consensus@mail.nih.gov. We thank you for your participation. You may disconnect your lines at this time and have a great day.




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