By Erika Check Hayden
The 25,000 US women who give birth at home each year received shocking news from the nation's obstetricians early this year. Babies born at home die within their first month of life at two to three times the rate of children born in hospitals, the American Congress of Obstetricians and Gynecologists (ACOG) declared on the basis of a review published in July 2010.
But the study behind the warning is not as definitive as it seemed. Before the ACOG warning, the study generated so much criticism that the journal that published it, the American Journal of Obstetrics & Gynecology, was investigating it. The post-publication review documented errors in the original analysis, but it did not contradict the study or change the paper's conclusions, and the problems do not warrant a retraction, according to Elsevier in New York, the company that publishes the journal.
The ongoing debate over the study underscores the difficulty of conducting objective reviews on controversial medical topics such as home birth, says Andrew Vickers, a statistician at the Memorial Sloan-Kettering Cancer Center in New York.
"The scientific debate about home birth has become extremely polarized and politicized," Vickers says. "It is becoming hard to be anything but skeptical about anything but the most carefully conducted randomized trials."
The home-birth study was published last July by Joseph Wax, a specialist in maternal fetal medicine at the Maine Medical Center in Portland and his colleagues, who conducted a meta-analysis of 12 studies on home and hospital births. Using data from a subset of four of these studies, Wax's team concluded that babies born at home without birth defects were more likely to die in their first 28 days of life than those born in hospitals.
Soon after the study came out, epidemiologists, nurses, midwives, some obstetricians and home-birth advocates alleged that the paper did not meet standards set out in internationally recognized systems promoting best practice in conducting and reporting meta-analyses, such as the Cochrane Collaboration's Cochrane Reviews for evidence-based healthcare and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement.
Divergent methods
Researchers had also identified potential errors in the study's statistics. For instance, Carl Michal, a physicist at the University of British Columbia in Vancouver, Canada, identified an error in an online meta-analysis calculator used by Wax's team to arrive at some of its conclusions. The developer of that calculator acknowledged the error and has alerted potential users to the problem.
And Karin Michels, an epidemiologist at Harvard Medical School in Boston, Massachusetts, points out that Wax's team did not provide measurements of the variations between the studies included in its analysis; when studies diverge widely in methods and outcomes, they should not be combined, Michels says. As a result, she says, readers can't know how much the studies included may differ and whether it was appropriate to combine them.
In a statement sent to Nature, Elsevier says that in response to the criticisms, the journal enlisted three "specialists in maternal fetal medicine with expertise in meta-analysis and clinical research" to examine all the correspondence that the journal had received regarding the Wax paper. The reviewers attempted to reconstruct Wax's calculated risks for three outcomes: deaths of neonates, or infants from birth to 28 days old; premature births before 37 weeks of gestation; and 'postmature' births after 42 weeks of gestation, according to Elsevier. Postmaturity can carry risks such as diminished amniotic fluid. "In all 3 cases, the results the panel found were slightly different from that in the Wax paper," says Elsevier, although the panel did not find major differences in the risk estimates or the overall statistical significance of the results.
The review committee recommended that the journal publish full summary graphs online for each outcome in the study, "which will allow readers to better assess the study findings", says Elsevier. But the committee did not recommend a retraction of Wax's paper by the journal. "There were a number of issues raised in the letters, many of which the panel felt were subjective and should be debated openly," Elsevier told Nature.
On 28 February, Wax's team posted the requested summary graphs on the journal website. The risk of newborn death and postmaturity among babies born at home is now higher than it was in the original paper, and the risk of prematurity is now lower. The document does not discuss whether or how Wax's group erred in its original calculations, or what changes were made to produce the new results.
Controversial exclusion
Critics are not appeased, because many had argued that Wax's team erred by inappropriately including or excluding studies from some of these outcomes in the first place. Epidemiologists consulted by Nature, who are not involved in the home-birth debate, agreed that there were problems with the study design.
Diana Petitti, an epidemiologist at the Arizona State University Center for Health Information and Research in Phoenix who authored a book on meta-analysis, says Wax's group should not have excluded data from a major Dutch study, published in 2009, that examined more than 300,000 home births for many outcomes, including the risk of newborn deaths. That study found no increased risk of death after home birth in the first week of life.
Petitti says this issue could have led to incorrect conclusions even if the statistical methods were sound. "The problem of excluding the Netherlands study dwarfs any problem related to software or the statistical models," she says.
ACOG and Wax declined multiple requests from Nature for comment. But the journal will publish more letters regarding the study and responses from Wax in coming weeks.
Elsevier says the journal did not notify ACOG about the investigation of Wax's study. Nonetheless, the substantial public criticisms of the paper should have given ACOG "some reservations" about using the study in its statement about home births, said David Moher, a clinical epidemiologist at the University of Ottawa and chair of the PRISMA Statement.
But, Moher says, it is unfortunately common for reviews to contain major methodological flaws.
"The quality of non-Cochrane Reviews leaves much to be desired," he says.
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15 Comments
Add CommentIt is possible that the report is biased.
Reply | Report Abuse | Link to thisAn 82 year old born at home with the help of a mid-wife.
So much BS so little minds. Babies were born at home or in the woods or on the sand for centuries. They were being born WAY before hospitals. In fact hospital births is a very new thing. You or baby are much more likely to catch something in a hospital than at home. Mid-wives are the best thing ever!!!!! This is just offensive to someone who doesn't buy into all the BS articles like this that they try to feed people.
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Reply | Report Abuse | Link to thisIt is rather ironic that while homebirth midwives attempt to discredit the Wax study, they steadfastly refuse to publish the safety data that they have collected.
MANA (The Midwives Alliance of North America) the trade organization for homebirth midwives (certified professional midwives, CPMs) spent the years 2001-2008 collecting a tremendous amount of data. Over the years MANA repeatedly told its members that more extensive safety data was forthcoming, encompassing approximately 18,000 CPM attended planned homebirths. MANA has announced completion of the data collection and publicly offered the data to others.
So why haven't we seen the death rates for CPM attended homebirths? MANA will only reveal the data to those who can prove they will use it "for the advancement of midwifery" and even these "friends" of midwifery must sign a legal non-disclosure agreement providing penalties for those who reveal the data to anyone else.
In other words, MANA's own safety data shows that homebirth increases the risk of neonatal death, possibly quite dramatically.
Complaints about the Wax study are a red herring. The organization that represents American homebirth midwives KNOWS that homebirth increases the risk of neonatal death. Their own data is so compelling on this point that they don't dare release it.
The Midwives Alliance of North American has an ethical duty to release its own neonatal death rates. There is absolutely no justification for keeping this information from the American public. Rather than questioning the Wax study, we should be asking what MANA is hiding and why.
Reply | Report Abuse | Link to this"In other words, MANA's own safety data shows that homebirth increases the risk of neonatal death, possibly quite dramatically"
Were did that come from. There is no way what you said can be summerized like that. You can't just make something up, stick "In other words" before it and expect it to magically become true.
MD? maybe, valid critical thinking in your comment, no.
Being a woman who has given birth both in the hospital and at home, I can testify that home births are less stressful, safer, cleaner, and more conducive to positive mental health. As far at the reported loss of infants born at home vs born under hospital care, I think they really are talking about loss of income, not actual lives. The "scary midwife" propaganda stems from the "doctors are God" school of medicine. Women have been giving birth for thousands of years. It's not rocket science. There are billions of us around. Stop your hysteria, and if you ain't tried it, don't knock it.
Reply | Report Abuse | Link to thisWhat you are addressing is your own medical school indoctrination, and the bias infused into your thinking by your belief in your "educational superiority." Where women choose to give birth should be supported, not condemned. If you care about women, then help women and midwives, not suppress them, or condemn them. Home birth is a spiritual, family-enhancing, emotionally uplifting, and joyous event. I've done it both ways- your way with gadgets, monitors, and scary sterile attendants, and at home with real faces and people I trust around me. Have you?
Reply | Report Abuse | Link to thisYes babies have been born at home for millenia. But don't forget that infant mortality and death during child birth was also very common. Why are we reverting to third world birthing methods? Can a midwife perform an emergency c-section which can mean the difference between a healthy baby or a severely brain damaged baby? Can she administer a blood transfusion before the mother bleeds to death? Home births play Russian roulette with the lives of mother and baby. You find hospitals and monitors scarey? They ensure a safe delivery. Labour and delivery is a temporary state but caring for a brain damaged child is permanent for the rest of your life, if you still have one.
Reply | Report Abuse | Link to thisWell said, Scico.
Reply | Report Abuse | Link to thisruspert, your comment is based on a sample of one. My personal experience is that hospital birth is better, also a sample of one. Clearly, neither of us can speak definitively on the subject, our samples being way too small (plus we know very little about fetal or maternal medicine). We could also both be wrong, and maybe (unlikely, but just as an example) births in ponds are even better.
Reply | Report Abuse | Link to thisSo, I prefer to check the results of large sample studies and meta-analyses instead of relying on personal experience and anecdotes from friends. Provided the studies are solid.
Is this study solid? I notice the article says that the criticism revolved around the point that the methodology of the Wax study could have been improved. However, after the necessary improvements, there is no material difference in the conclusion. Is continued ruckus manufactroversy then?
MANA is the largest group of professional, or lay, midwives in North American. They did a study of 18,000 home attended births. The study results have been prepared. MANA refuses to release their data to anyone outside their own community, and even then, an "agreement" has to be signed not to use the data for anything other than "the advancement of midwifery".
Reply | Report Abuse | Link to thisIf the data were favorable toward home birth, don't you think they would be shouting it off the roof tops!
For MANA to be silent, it could only mean bad news. It doesn't take a special amount of critical thinking to reach that conclusion.
All that "scary stuff" is there to protect the safety and life of you and your baby in the event that something goes wrong during your birth. "Family enhancement, joyousness, and enrichment" are very pretty words, but do nothing to enhance the safety of the birth experience for those women and babies who have a life-threatening incident during birth. I've been there...have you?
Reply | Report Abuse | Link to thisThe real story here has very little to do with the statistical and methodological soundness of the Wax study. This is pseudoscience attempting to make itself more palatable to the mainstream by adopting quasi-scientific trappings. There is an organized movement of people out there who are mounting a strategic campaign to advance their own ideology-driven agenda about childbirth. They believe that birth is inherently safe and highly spiritual and that any attempt to make it safer is actually dangerous. Of course, they want everyone else to believe this too, so they've decided that if they yell loud enough they can drown out the truth. They submit ridiculous studies with massaged data to their biased journals, then viciously attack everyone who publishes something that doesn't agree with their dogma.
Reply | Report Abuse | Link to thisAs a woman, I find it noxious. I'm sick of being innundated with this garbage. Most of us don't consider childbirth to be the defining moment of our lives. I find it ironic that there's a link on this page to another story about women in third world countries dying in childbirth. One of the quotes- "There are still many parts of the world where the mode of delivery is the home, and it's difficult to really deal with emergencies in that setting," says Robert Black, a professor of international health at the Johns Hopkins Bloomberg School of Public Health."
Why exactly do we want middle class women in developing countries to receive third world care? You don't need a study to understand that sometimes complications arise during birth that require immediate medical intervention of the sort that a midwife in a private home will not be able to provide. The majority of babies will be fine, but some will not. If people know and understand that and choose it anyway, fine, but proselytizing universally about safety is wrong and potentially dangerous.
I truly believe that in this day and age it is backward and anti-woman to advocate that childbirth should be relegated to some kind of primitive status, outside the standards of safety and pain relief common to the rest medical care. it's just a bunch of lies and bullying.
I am a mother of 13 children and I have had all of them in the hospital. I have alot of friends that have home-birthed their children and I don't know of any fatalies. I prefer to go to the hospital and they prefer to stay at home. I feel it is up to the person and where their safety, comfort and confidence is. I feel more comfortable having people with lots of experience and technology available to use in case of a problem. This really needs to be a choice. I just pray that each person puts all their trust in God who is able to see them through. www.cosmicgrandeur.com
Reply | Report Abuse | Link to thisThe midwifes today aren't not the midwifes of 1000 years ago. They have also the most developed instruments with.
Reply | Report Abuse | Link to thisThey can't make a C.S. clearly, but this isn't their job.
They can identify if and when C.S. is necessary. In time!
Even in a hospital environment you have wait min. 30 min. until an operation unit can receive a patient. In this time the mother can arrive in the hospital.
The midwive can made an infusion at home if it is necessary. That is more than enough to prevent collapse or shock. Not even in hospital is possible immediately obtain a blood transfusion. The first step is also there an infusion: volumen control.
The midwive can also manage most time the birth that a C.S. and/or transfusion e.s.o. is not necessary...
The lack of oxigen is doe 33% to the intra uterine life, 33% to the birth and 33% to the after birth life.
The valid statistics show that in home birth is less morbitity than in hospital. That is the fall of oxigenation also.
Mothers and falmily aren't idiots, they have weighted which is the most advantegous for the WHOLE family, and if something happened they can assume the responsability of their FREE consent choise.
If there is a tragedy that is first at all, their tragedy and THEY must live with.
Please read the paper of Pat Janssen (British Columbia) on the matter:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2742137/
It is nowhere a good choice: if you are for this solution you can encounter a problem, if you have choiced the other can be an other kind of problem.
The life is not warranted 100%.
You can fly, and the airplain crashs. You have a fear of fly you go by train, and the train may crash. Not even walking is safe...
Thank you, Marc Lévesque...
Reply | Report Abuse | Link to thisI will "Ditto" your comments.
"Dr" Tuteur is guilty of spinning her own opinionated words and personal agenda into the fray. THE most vocal, anti-homebirth person on the internet today... she is the "Spin Dr" of biased rhetoric, spewing libelous statements into nearly every comment section of nearly every article or report on home birth and midwifery care.
An UNlicensed, formerly practicing OB/Gyn (age 53), who has not practiced medicine, let alone assisted a women giving birth in any setting since before 2003 (she let her license lapse: http://profiles.ehs.state.ma.us/Profiles/Pages/PhysicianProfile.aspx?PhysicianID=39270), Amy Brenner Tuteur's ONLY creditably (that of being trained as a physician at Harvard) lacks merit today. She contradicts herself at every turn, advocating for women to make their own best choices about their birth care, yet demonizes home birthing women while defending those who elect cesarean by maternal request. She "claims" she left practice to raise her children... perhaps she couldn't manage the demands of being a physician with those of being a mother. Good for her children AND especially for the women she would have cared for (they might have all had cesareans so that she could get home to her family for dinnertime.) Better that she make casseroles than catch babies.