Wednesday, May 11, 2016

Skin-to-Skin Care After Cesarean

Image by Nicole Monet Photography
Although cesareans are generally over-used in most developed countries, sometimes they are truly needed. Thank goodness we have them as an option when they are needed.

But even a necessary cesarean can be difficult or even traumatic at times. Cesareans have also been found to negatively impact breastfeeding initiationduration, and formula supplementation rates.

One of the most consistent things heard from cesarean moms is how hard it is to be separated from her baby. Obviously, sometimes this is medically necessary, but babies have been routinely separated from their mothers even when there is no medical necessity. This separation can last for hours, sometimes even many hours. Research shows that this can negatively impact bonding and maternal interaction with the baby.

Many cesarean mothers say it feels like everyone gets to hold and take care of the baby before she does, which is difficult. Surgical birth can be a very passive experience for the mother, who may feel disconnected and distant from the baby afterwards.

In an effort to humanize and improve the cesarean experience, some doctors began experimenting with changing the care given during cesareans. The mother is prepped, and sometimes a clear drape is used so the parents can see the baby being delivered (if they wish). Often, the doctors wait a few minutes to cut the cord, letting the baby have the benefits of delayed cord clamping.

Then the baby is laid directly on the mother's bare chest, "skin to skin" as it were, which has been shown to have significant benefits. The mother's body warms the baby (along with blankets on top of both), the baby gets flora from the mother's skin, and the baby picks up the subtle cues that encourage early latching on for nursing. Thus, the baby is more gently transitioned to the outside world while the doctors finish stitching up the mother.

Some resources call this a "natural" cesarean, but this is a poor term, since surgery is anything but natural and the term tends to unrealistically minimize the realities of surgical birth. Many people feel that "gentle" cesarean or "family-friendly" cesarean are better alternative terms.

Women have been asking for many years for the drape to be lowered at the baby's delivery, and for the baby to go directly to them instead of to the nursery. For years, doctors have said that they couldn't do skin-to-skin in the operating room because it would delay treatment of the baby, might increase risk of infection for mother or baby, might increase hypothermia (low body temperature) of the newborn, and would interfere with the surgery.

But now, more and more hospitals are exploring this option because of consumer demand. The question is, how does this impact outcomes?

Skin-to-Skin After Cesarean Improves Outcomes

In a recent study, doctors looked at many of these questions in detail. Do mothers and babies who had skin-to-skin cesarean sections (SSCS) have worse outcomes?

The answer was that NO, mother-baby dyads having skin-to-skin care after cesareans did not have worse outcomes; they often had better outcomes instead.

For example, in the study, far fewer babies were admitted to intensive care after a SSCS than after a conventional cesarean (9.5% vs. 18%). Also, fewer had a suspected neonatal infection (2.0% vs. 7.3%).

There were slightly more surgical site infections in the SSCS group but the difference did not rise to statistical significance and could have been the result of chance. Surgical times were slightly longer (about 5 minutes longer on average) in the SSCS group but the recovery time was shorter by about 15 minutes on average.

This is not the only study to find positive results associated with skin-to-skin care after cesarean. A recent literature review found that a SSCS increased breastfeeding initiation rates, reduced time to first breastfeeding, decreased formula supplementation, reduced newborn stress, and improved maternal bonding.

Another recent study found that babies who experienced a SSCS did not experience more hypothermia than those born by conventional cesarean.

Basically, pretty much every objection traditionally used against skin-to-skin care after a cesarean has been debunked. So why isn't this routinely used in hospitals now? The answer is that medical culture can be difficult to change. The routines around surgical birth are firmly entrenched in most hospitals and it has been difficult to change the beliefs of many staff members, despite research showing the benefits of "gentle" cesareans.

The good news is that there is a growing cultural shift to humanize cesarean birth in many institutions. The bad news is that it is taking a long time to catch on in some areas. It is up to consumers and healthcare providers to keep pressuring for change in hospital culture.

Conclusion

Mammals have a strong biological need to see and hold their offspring immediately at birth; those that are separated from their offspring often reject their babies or take sub-optimal care of them.

Thankfully, humans have higher reasoning capacity and can overcome this; many cesarean mothers bond just fine with their babies. However, it is also not uncommon to have initial bonding issues; many cesarean mothers feel disconnected, like they really aren't sure this is their baby or that they are just a temporary caretaker of the baby. Or they may feel guilt at pictures of the baby alone in the NICU after the birth, like they had voluntarily abandoned their baby.

Research clearly shows that when mothers and babies do not have quick contact after birth, it can negatively affect bonding and breastfeeding behavior, sometimes even long-term. Cesareans can be inherently traumatic because the nature of the surgical procedure in most hospitals usually means a significant delay like this.

Skin-to-skin contact has a powerful role to play in helping cesarean mothers bond more easily with their child and improve breastfeeding rates. A Cochrane review of skin-to-skin contact after a normal vaginal birth found that skin-to-skin contact improved breastfeeding rates and duration, lowered cardio-respiratory stress in babies, and decreased crying. They found "no apparent short- or long-term negative effects" from skin-to-skin contact. In other words, skin-to-skin contact had NO real risks, only benefits.

But for too long, those benefits remained out of reach for women who had cesareans. For years, doctors said skin-to-skin contact was too "risky" or logistically difficult to do during a cesarean. Some staff began advocating skin-to-skin care for fathers during a cesarean, which is better than nothing, but still left the mother out of the picture.

Happily, now that we know that skin-to-skin contact is safe and practical, more hospitals are starting to offer skin-to-skin contact for the mother during a cesarean in order to promote a more family-friendly experience. In one hospital, the rate of skin-to-skin contact at cesarean has increased from 20% to 60% in healthy term infants.

There is one caution, however. Many cesarean activists are concerned that some hospitals are trying to blunt criticism of excessive cesarean rates by making them more palatable to the public through these promotions. Some institutions may even try to sell parents on planned cesareans by promoting them as a "natural" alternative, implying they are just as safe as a vaginal birth. One recent study addresses this concern, stating:
It must be mentioned that a patient-centered approach to cesarean delivery should not be used to promote elective cesarean birth. We agree that vaginal birth is generally the safest mode of delivery, and each cesarean birth increases maternal risk during subsequent pregnancies.Yet when cesarean delivery is medically necessary, gentle cesarean may provide a positive birth experience for a family, rather than a surgery to be endured. Furthermore immediate skin-to-skin contact promotes early and successful breastfeeding, which may be adversely affected by cesarean birth compared with vaginal birth.
Let's be clear. The best way to increase breastfeeding rates and improve bonding is to lower the rate of non-indicated cesareans. However, when a cesarean becomes a reality, techniques like immediate skin-to-skin contact can help the experience become more family-friendly and humane.

Sadly, immediate skin-to-skin contact during a cesarean is still all too rare in hospitals, but the rate is increasing. It's long past time for this low-risk intervention to become the standard of care when a cesarean is done.



References

J Matern Fetal Neonatal Med. 2016 Mar 9:1-21. [Epub ahead of print] Risks and benefits of the skin-to-skin cesarean section - a retrospective cohort study. Posthuma S1, Korteweg FJ1, van der Ploeg JM1, de Boer HD2, Buiter HD3, van der Ham DP1. PMID: 26955857
OBJECTIVE: Comparing maternal and neonatal outcomes after conventional cesarean section (CS) versus a "natural" or "skin-to-skin"cesarean section (SSCS). METHODS: Retrospective cohort of women who underwent a SSCS (01-2013 until 12-2013) compared to conventional CS (08-2011 until 08-2012). CS before 37 weeks, under general anesthesia and in case of fetal distress were excluded. Main outcome measures were maternal blood loss, post-operative infection and admission; neonatal infection and admission; procedural outcomes. RESULTS: We analyzed 285 (44%) women in the SSCS-group and 365 (56%) in the conventional CS-group. There were no significant differences in surgical site infection (2.1% vs. 1.6%; RR 1.1; 95%CI 0.64-2.0), or other maternal outcomes. Fewer neonates born after SSCS were admitted to the pediatric ward (9.5% vs. 18%; RR 0.58; 95%CI 0.41-0.80) and fewer neonates had a suspected neonatal infection (2.0% vs. 7.3%; RR 0.40; 95%CI 0.19-0.83). No differences were observed for other outcomes. Mean operation time was 4m42s longer in the SSCS-group compared to the conventional CS-group (58m vs. 53m; 95%CI 2m44s to 6m40s). Mean recovery time was 14m46s shorter (114m vs. 129m; 95%CI 3m20s to 26m). CONCLUSION: Adverse maternal and neonatal outcomes were not increased after skin-to-skin cesarean compared to conventional cesarean delivery.
J Am Board Fam Med. 2014 Sep-Oct;27(5):690-3. doi: 10.3122/jabfm.2014.05.140014. Promotion of family-centered birth with gentle cesarean delivery. Magee SR1, Battle C2, Morton J2, Nothnagle M2. PMID: 25201938
PURPOSE: In this commentary we describe our experience developing a "gentle cesarean" program at a community hospital housing a family medicine residency program. The gentle cesarean technique has been popularized in recent obstetrics literature as a viable option to enhance the experience and outcomes of women and families undergoing cesarean delivery. METHODS: Skin-to-skin placement of the infant in the operating room with no separation of mother and infant, reduction of extraneous noise, and initiation of breastfeeding in the operating room distinguish this technique from traditional cesarean delivery. Collaboration among family physicians, obstetricians, midwives, pediatricians, neonatologists, anesthesiologists, nurses, and operating room personnel facilitated the provision of gentle cesarean delivery to families requiring an operative birth. RESULTS: Among 144 gentle cesarean births performed from 2009 to 2012, complication rates were similar to or lower than those for traditional cesarean births. Gentle cesarean delivery is now standard of care at our institution. CONCLUSION: By sharing our experience, we hope to help other hospitals develop gentle cesarean programs. Family physicians should play an integral role in this process.

Wednesday, April 27, 2016

Your Hospital Choice Significantly Influences Your Cesarean Risk

Image from Consumer Reports 

Consumer Reports has a new report out for Cesarean Awareness Month, focusing on the variations in cesarean rates at hospitals across the United States. It highlights how different a woman's risk for a cesarean is, depending on which hospital she chooses.

One analysis points out the wide variations in cesarean rates for low-risk mothers in the Consumer Reports investigation. For example, Crouse Hospital in Syracuse, New York had an 11% cesarean rate in low-risk mothers, while Hialeah Hospital in Miami, Florida had a high of 68% for the same group. That kind of massive variation suggests there is more to the cesarean story than simple medical need.

Disclaimer: It's always important to remind people that no one begrudges a cesarean that is truly needed. No one is less of a woman or a mother if she has a cesarean, and it's perfectly okay to be happy with your cesarean. Don't make this about any one person's particular birth story, but rather focus on the big picture.

The big picture here is that over-utilization of cesareans brings significant risks on a public health level. Mothers and babies are being endangered by doing too many cesareans. 


It's time to shine a light on hospitals' cesarean rates so consumers can make fully-educated decisions about where they want to give birth.

Cesarean Rates in Low-Risk Mothers

The Consumer Reports article focuses on the cesarean rate in first-time, low-risk mothers. These rates act as a sort of canary-in-the-coal-mine warning of excessive cesarean rates. Their article explains further (my emphasis):
Consumer Reports’ analysis focuses on first-time mothers-to-be who should be at low risk of needing a cesarean: pregnant women expecting just one child (not twins, triplets, or other multiples) whose babies are delivering at full-term in the proper position, which means coming out head first. 
The target C-section rate for those births, set by the Department of Health and Human Services, is 23.9 percent or less. That’s 10 percent less than the rate for such births in 2007, which the government uses as a baseline from which to improve. 
But many experts say that the ideal C-section rate for those births is even lower. “Getting under 24 percent for low-risk births is something all hospitals should be able to do, but for those deliveries, hospitals should be aiming even lower,” Main says.

Yet nearly six in 10 of the hospitals we looked at had C-section rates above the national target for low-risk births. That means that 40 percent of hospitals already achieved this goal. “This sends a message that almost all hospitals should be able to achieve this rate,” Main says. 
The risk of having a C-section also varied depending on where in the country women lived. In general, rates were higher in the Northeast and South, and lower in the West and Midwest. 
Three states plus the District of Columbia had C-section rates of 30 percent or higher: Mississippi (31 percent), Kentucky (32 percent), Florida (32 percent), and D.C. (35 percent). 
And four states had rates below 18.5 percent: South Dakota (14 percent), Wyoming (17 percent), New Mexico (18 percent), and North Dakota (18 percent).
It's nonsensical to think that the uteri of women in South Dakota are vastly more efficient than the uteri of women in Mississippi. There is something else influencing cesarean rates here besides true medical need.

The Science and Sensibility analysis points out that hospital culture plays a very strong role in influencing cesarean rates, as demonstrated by wide variations of cesarean rates in hospitals serving the same basic community: 
For example, 30 percent of low-risk deliveries at the University of Chicago Medical Center were by C-section, while at Northwestern Memorial Hospital, another teaching hospital just 10 miles away, only 17 percent were. 
In southern California, 22 percent of low-risk deliveries at Kaiser Permanente Riverside Medical Center were cesareans, compared with 35 percent of low-risk deliveries at nearby Riverside Community Hospital.
According to this analysis, some hospitals have been able to substantially reduce their cesarean rates over time simply by internally publishing the rates for individual providers within the hospital. When care providers saw their rates compared to those of their colleagues, they often changed behaviors that led to a reduction of cesarean rates. 

So why not make the cesarean rates for EVERY hospital in the country publicly available? Perhaps peer pressure can work on a hospital level too.

If hospitals had to acknowledge that other hospitals with similar patient risk levels and demographics could safely have lower cesarean rates than they did, they might put more effort into policies which would help change their own rates.

Transparency in Cesarean Rates

Transparency in healthcare is vitally important. Consumers have the right to know how their local hospitals rate in measures of quality of care, and to make an educated decision on where to take their business as a result.

Many hospitals are already reporting on their infectious morbidity and other measures of quality ─ why shouldn't parents be able to research the cesarean risk at their local hospital? Parents deserve to be able to make an educated choice, yet right now these reports are completely voluntary and many hospitals don't report results at all.

For example, some of the most prominent hospitals in the U.S., like Mount Sinai in New York City or Yale-New Haven in Connecticut, do NOT practice transparency in cesarean rates. The Consumer Reports article notes (my emphasis):
Consumer Reports does not have C-section rates for more than half of the estimated 3,000 U.S. hospitals that deliver babies. That’s because hospitals are not required to publicly report that information, and many choose not to.
This urgently needs to change. Hospitals should be required to have transparency in quality measures such as infectious morbidity and low-risk cesarean rates.

I'd go even further and suggest that the cesarean rates for EVERY PROVIDER be made publicly available. Sure, you can ask your providers their rates, but not every provider tracks this, and some lie about their rates. Providers need to be held accountable for their rates, and we know that publishing rates is effective in reducing non-indicated cesareans.

Most importantly, though, prospective parents deserve to be able to learn about their likelihood of surgery with a particular provider. How can you be an informed partner in your own care when you can't get basic information like about the performance of your hospital and your provider? Consumers have every right to this information. 

Furthermore, transparency can have the added benefit of providing motivation for hospitals and providers to improve their results so consumers are more likely to bring their business. Experience shows that when substandard results are highlighted and a program is developed to address the issues, outcomes can be improved.

Transparency is powerful stuff in healthcare, and it has the potential to motivate major changes.

Kudos to Consumer Reports for shining a major spotlight on this issue. Now it's time for the hospitals who are not being transparent to change their policies and be accountable too. Otherwise, who knows what's really happening in those hospitals? Or how many women are being subjected to the immediate and future risks of major surgery on dubious grounds?


Tuesday, April 5, 2016

Forced Cesareans Because of Weight

Photography by Leticia Valverdes, Birth Marks Photography
Photo and story at A Beautiful Body Project
April is Cesarean Awareness Month. I had a different post for it planned for this week, but then I came across this outrageous, infuriating story of a women of size in Brazil who was basically forced into two cesareans simply because of her weight. I simply HAD to comment and bring this to people's attention.

Here is the photographer's summary of her situation (my emphasis):
Elaine was two times forced into caesarean sections for no medical reason other than her obesity, including second one where she arrived in hospital already 9 cm dilated but was forced into a c-section as the obstetric doctor said she would not look after her and the baby if she insisted on a natural labour. She locked herself in the toilette with her doula but got scared and allowed the C when already 10 cm dilated. She was told she was too fat to labour.
Too fat to labor? Yet she was already dilated! She'd done all of labor except pushing. But her doctor could not be bothered to attend her in labor for pushing; I'm sure he felt she was too "high-risk" to push out a baby. Yet other fat women can push out their babies ─ when they are given a real opportunity, which is far too rare these days.

Also frustrating to me is the fact that EVERYONE so far has missed the fact that she almost certainly has lipedema. Look at her legs and her behind. Classic shape and texture of advanced lipedema! They are blaming her for her fatness (and she blames herself, as you can see from her comments about herself in the article) when likely a great deal of it is beyond her control. But that certainly doesn't mean she can't push out a baby. Many of us with lipedema have. It's just bias, pure and simple, on the part of the doctor. And that highlights a troubling trend in cesareans these days.


As the Cesarean Awareness Month logo above notes, the overall cesarean rate in the United States is too high, with almost 1 in 3 women having a cesarean. Yes, some of those are absolutely necessary and life-saving, and no woman should ever be shamed or feel like less of a mother or a woman if she has had a cesarean. Please don't think I'm putting you down if you've had a cesarean.

But a too-high cesarean rate has major public health implications that we are ignoring, and women's health is being impacted by this.

Sadly, high BMI women are being disproportionately affected by this high cesarean rate, and this has major implications for our health. 

Sure, this story is from Brazil where the cesarean rate is sky-high, but don't be naive; there are "obese" women here who are being railroaded into cesareans only because of their weight.

I have written about the high cesarean rate in obese women many times. If you want to read a post with extensive research details on it, read this one ─ Astronomical Cesarean Rates in Women of Size. It has plenty of references and explanations, but here are a few highlights.

Too many care providers have taken the view that fat women "can't" birth normally or are "too risky" to birth normally. One recent study showed that about 1 of 3 "morbidly obese" women are being pressured into cesareans before labor. So the 1 in 3 national c-section figure above? The same rate happens in high BMI women ─ except that's only the pre-labor cesareans in obese group.

What about those who labor? Even when women of size are "allowed" to labor, the high-intervention and high-risk way that they are often managed mean that the resulting cesarean rate is even higher.

In many recent studies, the cesarean rate in obese women is around 50%, or ONE IN EVERY TWO WOMEN. 

Where's the graphic that reflects that?!? Where is the outrage in the birthing community? Where is the accountability for providers? Where are the hospital programs to try to reduce the enormous cesarean rate in high BMI women? NOWHERE.

Check out this study from 2013 which documented cesarean rates in high-BMI women in Tennessee. Note how this cesarean-oriented culture results in especially high rates in "morbidly obese" women:

"Underweight" women (BMI less than 18.5) -      26.0%
"Normal Weight" women (BMI 18.6 - 24.9) -      31.4%
"Overweight" women (BMI 25 - 29.9) -               39.1%
"Obese" women (BMI 30 - 34.9) -                       40.8%
"Morbidly Obese" women (BMI 40+) -               56.6%

This reminds me of a similar study from Kentucky, showing cesarean rates in morbidly obese women near 60% also.

You can find studies with even higher rates too, like this very large, multi-state study from more than a decade ago which found a c-section rate of 71% for women with a BMI of 52 or more.

Or a more recent study that found a nearly 70% c-section rate in women with a BMI of 35 or more.

Then there's this study from Michigan, which had a total cesarean rate of MORE THAN 80% for women with a BMI over 50.

And the cesarean rate in obese women continues to rise unabated and unchecked.

One German study we discussed recently showed that while cesarean rates have increased in all groups over time, they've increased the most in "morbidly obese" women. In just 22 years, the cesarean rate in Class III Obese women doubled, going from 26.9% to 55.2%.

Why? What changed? These stats compare women of the same size, so it wasn't the women who changed. Most likely it was the management of those women that changed, and the fear levels around their pregnancies. 

If the cesarean rate in fat women has increased from 27% to 55% in 22 years, how far will it go in the next 22?

How Can We Change This Trend?

The good news is that it doesn't have to be this way. 

As I've pointed out before, there was a large recent British study that found a 30% cesarean rate in "super-obese" women (BMI 50 or more) who were given a chance to labor.

Yes, 70% of these super-obese women were able to give birth vaginallywhen given the chance to do so.

Yet hospitals in Kentucky and Tennessee, as cited above, had c-section rates of around 60%, nearly TWICE the British rate. And the Michigan study had rates even higher than that. Why?

These differences suggest that there are key differences in how high BMI women are being managed that is resulting in such wide variations in cesarean rates in this group, both over time and by location.

It's time for care providers to start focusing on the cesarean practice rate variation in obese women and learning from it. Once we acknowledge that there is a wide range in the obese cesarean rate, we can more easily start studying the things that help lower the risk for cesarean in this group, and hospitals can work on meaningful changes that will improve outcomes. But I have yet to see one study that seriously addresses this issue.

What Can Be Done?

Even if we have no study that directly addresses this issue, there almost surely are things that can be done to lower the cesarean rate in higher weight women. You start with the things that have been shown to lower the cesarean rate in women of all sizes and make sure these things are applied to women of size as well (which they often aren't).

Based on the evidence (references and explanations in the last section of the original article), the most logical ideas would include:
  • A strong emphasis on preventing the first cesarean, especially scheduled cesareans that occur before labor. Far too many doctors are not giving fat women a chance to labor at all and then repeat cesareans become nearly automatic. Prevent the first cesarean and you quickly impact the overall cesarean rate in this group 
  • Less early induction of labor unless it is truly medically indicated since induction often increases the chance of cesarean; when induction is used, wait until the mother's cervix is ready for labor whenever medically possible 
  • Dating pregnancies more accurately in women of size with longer menstrual cycles so that more are truly ready for labor at term and not being induced too early
  • Reduction in the overuse of common interventions in obese women, like early breaking of water, early epidurals, and routine pitocin augmentation
  • Encouraging women of size to stay home longer in early labor, since research shows that coming into the hospital too early is strongly associated with higher cesarean rates
  • Giving women of size MUCH more time and patience in labor to account for a possibly slower dilation curve and a longer first stage of labor
  • More utilization of midwifery and/or a midwifery-laborist model of care for low-risk obese women since this has been shown to decrease the risk for cesareans
  • Strongly encouraging use of doulas and professional labor support for women of size since doulas have been shown to reduce cesarean rates significantly
  • A re-emphasis on the importance of properly-sized equipment like blood pressure cuffs so interventions are only undertaken when truly needed, based on accurate data
  • More attention to preventing and treating fetal malposition in women of size (who may be more at risk for fetal malpositions)
  • More freedom of movement in labor and utilization of alternative positions in pushing, instead of immobilizing the obese woman in bed and reducing her pelvic space
  • Fewer late ultrasounds for estimating fetal weight, since prediction of fetal weight increases the chance of cesarean beyond the baby's size alone
  • A revival of VBAC access for high BMI women, with fewer VBAC inductions and more patience during a "trial of labor" to give it the maximum chance to happen
Start with these ideas, then hospitals should organize some serious trials to see if they help. Make reducing cesarean rates in high-BMI women a strong priority in research and in practice. 

Conclusion

It's outrageous that this poor woman from Brazil was forced into a cesarean TWICE simply because of her weight, even after she arrived at the hospital nearly fully dilated. 

It reminds me of the story, told by an OB, of getting into trouble with her colleagues because she let a morbidly obese woman VBAC. The woman arrived at the hospital fully dilated (and with a history of a prior vaginal birth). Her colleagues raked her over the coals for not doing an automatic c-section, simply based on the mother's size. They would have forced this mother into another cesarean, even though her body had already proven it could give birth safely, and even though she was fully dilated, based on nothing more than her weight. And this was in the U.S., not very long ago!

I've heard from other fat women who were strongly encouraged or even coerced into signing papers for an elective cesarean early in pregnancy, based only on size. While it's by no means universal, it does still happen. Higher-weight women ARE being forced into cesareans based on their size alone, even here and now. 

Thank goodness, not all providers are like this. Even as we are outraged by stories like these, we must remember and acknowledge that there are wonderful midwives and doctors out there who are truly size-friendly, who give women of size every chance at vaginal birth, and who do support them in VBAC as well. Some maternity providers are wonderful with women of size and it's vitally important that higher-weight women seek out and find these size-friendly providers. 

On the other hand, there is a real callousness around care of high-BMI women among some providers, even an outright viciousness at times. The lack of caring among many providers about the extreme cesarean rates in high-BMI women says a lot. Most shrug off a cesarean as a natural consequence of obesity, pretending that their hands are tied. Baloney.

Historically, cesarean rates in high-BMI women were not as different from average-sized women as they are today. As we have seen, the cesarean rate has increased markedly in obese women in recent years, and there is a great deal of variation in the obese cesarean rate between institutions. 

This means that a high cesarean rate is not an inevitable outcome of obesity, and that many fat women can give birth vaginally with the right support. It also means that there are ways to lower the cesarean rate in higher-weight women ─ if we are willing to study it and make change a priority.

Far too many of the cesareans in women of size today are “iatrogenic”— influenced more by the attitudes and management protocols of the care providers than by the woman’s size. Far too many high BMI women are sectioned before labor even starts, induced before their bodies are ready, or have their labors cut short out of impatience or fear. But research has shown that most women of size can give birth vaginally if they are just given a real chance to do so.

It's time we work to make that happen. Let's not hear about any more cases like poor Elaine. 

Wednesday, March 30, 2016

Can Inositol Prevent Gestational Diabetes?

We have written before about the use of inositol (either myo-inositol or d-chiro-inositol) to reduce insulin resistance in women with Polycystic Ovarian Syndrome (PCOS). It's a promising therapy, one that deserves far more research attention than it is getting so far.

But one of the pressing questions so far is whether or not it can reduce a woman's chance for raised blood sugar during pregnancy (Gestational Diabetes, or GD). Several recent studies from Italy have addressed this question.

How Inositol Works

Inositols are a group of carbohydrate compounds that exist in nine chemical orientations called stereoisomers; the two most important ones are myo-inositol and d-chiro-inositol. Your body uses bacteria from the gut to convert the phytic acid found in found in fruits, vegetables, legumes, whole grains, nuts, and other foods into inositols. They then play an important role inside the cell in insulin signaling.

In PCOS, this pathway does not seem to function properly. While most people can get the inositol they need from foods, women with PCOS may have difficulty converting naturally-occurring inositols into d-chiro-inositol (DCI). Or they may convert it reasonably well but excrete it too quickly and therefore do not have enough in the body to help utilize its insulin properly. Supplementing with exogenous (outside the body) sources of inositol is thought to help restore proper signaling function.

So, basically, the idea is that women with PCOS are not able to utilize the natural forms of inositol in their food and this causes insulin metabolism to be inefficient. This leads to a build-up of insulin in the body, which leads to the hormone imbalances of PCOS. And in pregnancy, it may lead to an increased risk for gestational diabetes. The hope is that treatment with inositol may help reduce these problems. 

Inositol and GD

During pregnancy, a temporary state of increased insulin resistance occurs because diabetogenic hormones are produced by the placenta in order to provide the fetus with more energy in case of famine or nutritional challenges. This happens in all women.

In normal pregnancies, the mother's insulin levels are able to respond enough to keep her blood sugar in the normal range, but in some women, the pancreas can't respond with enough insulin (or the body becomes too resistant to the insulin) to keep the blood sugar normal. These women are at high risk for getting GD in pregnancy, which in turn may lead to a higher rate of big babies, pre-eclampsia, and other problems. The women most at risk for GD include those with PCOS, those with a strong family history of diabetes, and high-BMI women.

As a result, a number of researchers have proposed using insulin-sensitizing medications routinely during pregnancy in these groups to reduce the risk of GD and other problems.

Or course, some insulin-sensitizing drugs cannot be used because they cross the placenta and can cause birth defects or low blood sugar in the newborn. Metformin is the usual drug of choice in recent years and seems relatively safe, but its performance has been mixed. So now researchers are proposing using inositols (usually myo-inositol) to reduce the risk for GD.

And indeed, some research has shown that women who develop GD in pregnancy tend to excrete high levels of inositol in their urine, suggesting their bodies are unable to convert/utilize it properly. And there is at least one small study that suggests that some women with already-diagnosed cases of GD can be effectively treated with inositols.

So might prophylactic treatment with inositol help prevent GD in women at high risk for the condition?

Studies on Inositol for GD Prevention

So far, the studies on using inositol to prevent or lower the incidence of GD are promising.

An April 2013 study found that myo-inositol lowered the rate of GD in non-obese women with a history of Type 2 diabetes in a close relative. The GD rate was 15.3% in the placebo group vs. 6% in the myo-inositol group.

A July 2013 study found that administering myo-inositol to women who had elevated fasting glucose levels in early pregnancy also lowered the rate of the development of GD.

A December 2015 study found that myo-inositol lowered the rate of GD in a population of "overweight" (BMI 25-30) women. The GD rate was 27.4% in the placebo group vs. 11.6% in the myo-inositol group.

An August 2015 study found that myo-inositol cut the rate of GD incidence in obese women (BMI 30 and over) in half; the GD incidence was 33% in the placebo group vs. 14% in the myo-inositol group.

Most significant of all, a small June 2012 study found that myo-inositol dramatically lowered the rate of GD in women with PCOS. The control group (treated with metformin until conception was confirmed, when it was stopped) had a 54% GD rate, whereas the myo-inositol group (treated before and throughout the entire pregnancy) had a 17.4% rate.

These are all very significant findings and some researchers are getting very excited about the use of inositols in pregnancy. We will undoubtedly see many more studies on this in the future.

Weaknesses of the Studies

However, some cautions are warranted in looking at these studies. One prominent GD researcher wrote a mostly-positive editorial on the use of myo-inositol for preventing GD, but noted a number of problems with the studies, echoing the reservations that I had as I reviewed the abstracts.

Generally, the study groups are pretty small. You need much larger studies to be sure there is a true benefit happening. Also, most serious complications are rare in pregnancy; you need really large study groups to confidently rule out potential safety issues like birth defects or perinatal mortality.

Also, the studies are all done in Italy; most of the inositol research these days is being done there. When all the research on a substance is being done in one particular area or by one set of doctors, that raises the question of bias. It will be very important to see this work replicated in other places and other populations.

The Italian hospitals have also concentrated mostly on myo-inositol. I'd also like to see researchers compare myo-inositol and d-chiro-inositol to see which has greater efficacy.

And of course, the potential for harm in pregnancy is always high because there is a baby involved. Since inositol is a substance your own body produces from food, you would think the risk should be low, but even nutrients that are beneficial in small doses (like vitamin A) can be harmful to fetuses in large doses. More research is needed to look for any possible neonatal effects, as well as to clarify optimal and safe dosages.

Furthermore we need to clarify when usage of inositols is safe. In most of these studies, myo-inositol was only given after the first trimester, so we don't really know if it has any effect on the development of babies early in the first trimester. In the study on obese women, myo-inositol was started in the first trimester but likely this occurred after organogenesis. People in the PCOS study took it throughout the whole pregnancy; no harm was found, but the study was quite small and much larger studies would be needed to see possible impact on rare outcomes.

Some animal models have suggested that large doses of myo-inositol can trigger uterine contractions, so that is another concern that must be addressed. No increase in prematurity was noted in the PCOS pregnancy study, but again, that study was too small to be definitive. Obviously, research that looks specifically at premature labor is needed.

One intriguing finding has been that inositol use (especially d-chiro-inositol) has lowered the risk for Neural Tube Defects (NTDs) in folate-resistant mouse models. A defect in insulin-signaling pathways might be a plausible explanation for why obese women have a somewhat higher risk for neural tube defects than other women. Although no research on obese women has been done, preliminary research on inositol supplementation in women who are at high risk for a NTD because of a prior NTD-affected fetus has been promising. On the other hand, because NTDs are rare, it will probably be a very long time before we know for sure whether inositol use lowers the risk of NTDs in obese women. 

In addition, as a Cochrane Review noted, studies were inconsistent in reporting neonatal outcomes, and the overall quality of studies were judged to be of low or very low quality. The review found the preliminary GD results quite favorable, but strongly encouraged larger, more diverse, and better-designed research.
So while the initial results from these inositol in pregnancy studies are quite promising, there is definitely room for reservations too.

Final Thoughts

Personally, I am very intrigued by the potentials of inositol use. I find the research around the use of inositols outside of pregnancy to be very promising so far, and I'm intrigued by the anecdotal benefits many women with PCOS have reported. To me the mechanism of action seems quite plausible and it is logical that inositol supplementation might be useful. Since myo-inositol is very inexpensive and easy to find, inositols have tremendous potential as a therapy ─ if they are effective and safe.

However, I'm always a little bit leery when researchers start experimenting with interventions during pregnancy. History is littered with examples of things we thought were a good idea in pregnancy, were adopted without adequate research, and which actually turned out to be ineffective or even harmful.

I also have mixed feelings about the fact that doctors are pushing this treatment with high-BMI women regardless of glycemic status or PCOS diagnosis. Some researchers have pushed the envelope of ethical behavior at times to try to reduce possible complications in obese women, and I'm deeply concerned doctors will start pushing these treatments before they are truly proven to be effective and without harm.

On the other hand, high-BMI women clearly do have increased risks for some complications, including gestational diabetes. If a way to prevent GD could be found, that might improve outcomes in some women. As long as this is treated as experimental research, done with proper protocols and truly informed consent, it is important that these studies go forward ─ but it's equally important that women have the right to opt out of them without penalty if they decide they are uncomfortable with the potential risks. Nor should inositols be incorporated into routine care at this point.

As we have written about before, metformin was thought to be the miracle drug for preventing problems in women with a high potential for insulin resistance. However, more thorough research has shown its usefulness to be mixed.

Metformin has certainly been shown to be useful in managing gestational diabetes once it is diagnosed. And in women with PCOS, a number of small initial studies showed that metformin was helpful in reducing miscarriage, pre-term birth, and perhaps GD and blood pressure issues.

However, a recent randomized study did not show that metformin was useful in preventing GD among women with PCOS, although researchers noted the need for further large studies to confirm this. It should also be noted that metformin does seem to lower the rate of miscarriage pretty consistently, so it still may be a useful drug for PCOS, even if it doesn't prevent GD.

But outside of PCOS and GD treatment, metformin's use in pregnancy is more doubtful. Two recent large studies have found that metformin was not useful in preventing GD or lowering birth weight in babies of high-BMI women with normal glucose tolerance. The authors concluded that metformin should not be be used routinely to prevent complications in obese women.

So there is plenty of precedent for a promising therapy that looked like THE cure-all for prevention of complications associated with insulin resistance in pregnancy. Yet so far, none of these therapies have proven to be useful across the board. Useful under certain conditions, yes, but not for routine use.

Still, the recent research on inositols in pregnancy is very interesting. The inositols are an intriguing, plausible possible treatment, and anecdotally some women with PCOS have achieved great results with them, but this is not the same as having quality research on its use and safety in pregnancy. More research is vitally needed, with larger study groups, more varied populations, and stricter study designs.

Keep your eyes peeled for future developments, as research into the inositols is expanding. Until then, use of the inositols in pregnancy should remain a matter of individual decision-making between a woman and her provider, with full informed consent.

References

Inositol and High-BMI Pregnant Women

Obstet Gynecol. 2015 Aug;126(2):310-5. doi: 10.1097/AOG.0000000000000958. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. DʼAnna R1, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. PMID: 26241420
OBJECTIVE: To evaluate whether myo-inositol supplementation, an insulin sensitizer, reduces the rate of gestational diabetes mellitus (GDM) and lowers insulin resistance in obese pregnant women. METHODS: In an open-label, randomized trial, myo-inositol (2 g plus 200 micrograms folic acid twice a day) or placebo (200 micrograms folic acid twice a day) was administered from the first trimester to delivery in pregnant obese women (prepregnancy body mass index 30 or greater). We calculated that 101 women in each arm would be required to demonstrate a 65% GDM reduction in the myo-inositol group with a statistical power of 80% (α=0.05). The primary outcomes were the incidence of GDM and the change in insulin resistance from enrollment until the diagnostic oral glucose tolerance test. RESULTS: From January 2011 to April 2014, 220 pregnant women at 12-13 weeks of gestation were randomized at two Italian university hospitals, 110 to myo-inositol and 110 to placebo. Most characteristics were similar between groups. The GDM rate was significantly reduced in the myo-inositol group compared with the control group, 14.0% compared with 33.6%, respectively (P=.001; odds ratio 0.34, 95% confidence interval 0.17-0.68). Furthermore, women treated with myo-inositol showed a significantly greater reduction in the homeostasis model assessment of insulin resistance compared with the control group, -1.0±3.1 compared with 0.1±1.8 (P=.048). CONCLUSION: Myo-inositol supplementation, started in the first trimester, in obese pregnant women seems to reduce the incidence in GDM through a reduction of insulin resistance.
J Matern Fetal Neonatal Med. 2015 Dec 23:1-4. [Epub ahead of print] Myo-inositol may prevent gestational diabetes onset in overweight women: a randomized, controlled trial. Santamaria A1, Di Benedetto A2, Petrella E3, Pintaudi B2, Corrado F1, D'Anna R1, Neri I3, Facchinetti F3. PMID: 26698911
OBJECTIVE: To evaluate whether myo-inositol supplementation may reduce gestational diabetes mellitus (GDM) rate in overweight women. METHODS: In an open-label, randomized trial, myo-inositol (2 g plus 200 μg folic acid twice a day) or placebo (200 μg folic acid twice a day) was administered from the first trimester to delivery in pregnant overweight non-obese women (pre-pregnancy body mass index ≥ 25 and < 30 kg/m2). The primary outcome was the incidence of GDM. RESULTS: From January 2012 to December 2014, 220 pregnant women were randomized at two Italian University hospitals, 110 to myo-inositol and 110 to placebo. The incidence of GDM was significantly lower in the myo-inositol group compared to the placebo group (11.6% versus 27.4%, respectively, p = 0.004). Myo-inositol treatment was associated with a 67% risk reduction of developing GDM (OR 0.33; 95% CI 0.15-0.70).  CONCLUSIONS: Myo-inositol supplementation, administered since early pregnancy, reduces GDM incidence in overweight non-obese women.
Inositol and Pregnant Women at Strong Risk for Diabetes

Diabetes Care. 2013 Apr;36(4):854-7. doi: 10.2337/dc12-1371. Epub 2013 Jan 22. myo-Inositol supplementation and onset of gestational diabetes mellitus in pregnant women with a family history of type 2 diabetes: a prospective, randomized, placebo-controlled study. D'Anna R1, Scilipoti A, Giordano D, Caruso C, Cannata ML, Interdonato ML, Corrado F, Di Benedetto A. PMID: 23340885
OBJECTIVE: To check the hypothesis that myo-inositol supplementation may reduce gestational diabetes mellitus (GDM) onset in pregnant women with a family history of type 2 diabetes. RESEARCH DESIGN AND METHODS: A 2-year, prospective, randomized, open-label, placebo-controlled study was carried out in pregnant outpatients with a parent with type 2 diabetes who were treated from the end of the first trimester with 2 g myo-inositol plus 200 µg folic acid twice a day (n = 110) and in the placebo group (n = 110), who were only treated with 200 µg folic acid twice a day...RESULTS: Incidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group: 6 vs. 15.3%, respectively (P = 0.04). In the myo-inositol group, a reduction of GDM risk occurrence was highlighted (odds ratio 0.35). A statistically significant reduction of fetal macrosomia in the myo-inositol group was also highlighted together with a significant reduction in mean fetal weight at delivery. In the other secondary outcome measures, there were no differences between groups. CONCLUSIONS: myo-Inositol supplementation in pregnant women with a family history of type 2 diabetes may reduce GDM incidence and the delivery of macrosomia fetuses.
J Matern Fetal Neonatal Med. 2013 Jul;26(10):967-72. doi: 10.3109/14767058.2013.766691. Epub 2013 Mar 1. Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial. Matarrelli B1, Vitacolonna E, D'Angelo M, Pavone G, Mattei PA, Liberati M, Celentano C. PMID: 23327487
OBJECTIVE: To test the hypothesis that dietary myo-inositol may improve insulin resistance and the development of gestational diabetes mellitus (GDM) in women at high risk of this disorder. DESIGN: A prospective, randomized, double-blind, placebo controlled clinical trial, pilot study. PARTICIPANTS: Non-obese singleton pregnant women with an elevated fasting glucose in the first or early second trimester were studied throughout pregnancy...RESULTS: Thirty-six women were allocated to receive myo-inositol and 39 placebo. The incidence of GDM in mid-pregnancy was significantly reduced (p = 0.001) in women randomized to receive myo-inositol compared to placebo (relative risk 0.127). Women randomized to receive myo-inositol also required less insulin therapy, delivered at a later gestational age, had significantly smaller babies with fewer episodes of neonatal hypoglycemia. CONCLUSIONS: Myo-inositol supplementation in pregnancy reduced the incidence of GDM in women at high risk of this disorder. The reduction in incidence of GDM in the treatment arm was accompanied by improved outcomes.
Inositol Use in Pregnant Women with PCOS

Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28. Myo-inositol may prevent gestational diabetes in PCOS women. D'Anna R1, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. PMID: 22122627
To evaluate retrospectively the prevalence of gestational diabetes (GD) in pregnancies obtained with myo-inositol administration in women with polycystic ovary syndrome. A total of 98 pregnancies in PCOS women obtained in a 3-year period, either with myo-inositol (n. 54), or with metformin (n. 44) were considered. While myo-inositol was assumed through the whole pregnancy, the group of women treated with metformin stopped the drug assumption after pregnancy diagnosis, and was considered as a control group. After having eliminated cases of miscarriages and twin pregnancies, a definitive number of 46 women in the myo-inositol group and 37 in the control group was taken in account to be retrospectively evaluated. The primary outcome measure was GD occurrence in both groups; whereas secondary outcome measures were pregnancy outcomes: hypertensive disorders, pre-term birth, macrosomia and caesarean section occurrence. Prevalence of GD in the myo-inositol group was 17.4% versus 54% in the control group, with a highly significant difference also after adjusting for covariates. Consequently, in the control group the risk of GD occurrence was more than double compared to the myo-inositol group, with an odds ratio 2.4 (confidence interval 95%, 1.3-4.4). There was no difference between the groups in relation to secondary outcome measures. This study suggests a possible effect of myo-inositol in the primary prevention of GD in PCOS women.
Meta-Analysis on Inositol for Preventing GD

Cochrane Database Syst Rev. 2015 Dec 17;12:CD011507. doi: 10.1002/14651858.CD011507.pub2. Antenatal dietary supplementation with myo-inositol in women during pregnancy for preventing gestational diabetes. Crawford TJ1, Crowther CA, Alsweiler J, Brown J. PMID: 26678256
BACKGROUND: ...Myo-inositol, an isomer of inositol, is a naturally occurring sugar commonly found in cereals, corn, legumes and meat. It is one of the intracellular mediators of the insulin signal and correlated with insulin sensitivity in type 2 diabetes. The potential beneficial effect on improving insulin sensitivity suggests that myo-inositol may be useful for women in preventing gestational diabetes...MAIN RESULTS: We included four randomised controlled trials (all conducted in Italy) reporting on 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The trials had small sample sizes and one trial only reported an interim analysis. Two trials were open-label. The overall risk of bias was unclear. For the mother, supplementation with myo-inositol was associated with a reduction in the incidence of gestational diabetes compared with control (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.29 to 0.64; three trials; n = 502 women). Using GRADE methods this evidence was assessed as low with downgrading due to unclear risk of bias for allocation concealment in two of the included trials and lack of generalisability of findings...AUTHORS' CONCLUSIONS: Evidence from four trials of antenatal dietary supplementation with myo-inositol during pregnancy shows a potential benefit for reducing the incidence of gestational diabetes. No data were reported for any of this review's primary neonatal outcomes. There were very little outcome data for the majority of this review's secondary outcomes. There is no clear evidence of a difference for macrosomia when compared with control.The current evidence is based on small trials that are not powered to detect differences in outcomes including perinatal mortality and serious infant morbidity. All of the included studies were conducted in Italy which raises concerns about the lack of generalisability of the evidence to other settings. There is evidence of inconsistency and indirectness and as a result, many of the judgments on the quality of the evidence were downgraded to low or very low quality...Further trials for this promising antenatal intervention for preventing gestational diabetes are encouraged and should include pregnant women of different ethnicities and varying risk factors and use of myo-inositol (different doses, frequency and timing of administration) in comparison with placebo, diet and exercise or pharmacological interventions. Outcomes should include potential harms including adverse effects.

Sunday, March 20, 2016

Most Babies Suspected to be Large Actually Aren't


So many mothers get the "big baby" fear card handed to them during pregnancy. This often leads to pressure for interventions such as induction of labor, or scaring women into a planned cesarean.

In this survey, one-third of women surveyed were told their babies were getting "quite large." Yet only one in five of these women actually went on to have large babies (around 9 lbs. or more).

Although the survey doesn't have information specifically about women of size, I would bet that the rate of big baby fear cards is even higher in our care. There is some justification for this; on average, we do tend to have somewhat larger babies. But even so, most high-BMI women have average-sized babies. And even if they do have a bigger baby, most of these can be born just fine with a little care and patience, especially if they have full mobility during labor.

But the fear of big babies from big mothers is so exaggerated these days that many care providers act as if every high-BMI woman will have a Godzilla Baby. Sadly, a great deal of the increased interventions we experience is likely tied to that fear of big babies.


Reference

Matern Child Health J. 2015 Dec;19(12):2578-86. doi: 10.1007/s10995-015-1776-0. Labor and Delivery Experiences of Mothers with Suspected Large Babies. Cheng ER1, Declercq ER2, Belanoff C3, Stotland NE4, Iverson RE5. PMID: 26140835
OBJECTIVE: To characterize the prevalence of and factors associated with clinicians' prenatal suspicion of a large baby; and to determine whether communicating fetal size concerns to patients was associated with labor and delivery interventions and outcomes. METHODS: We examined data from women without a prior cesarean who responded to Listening to Mothers III, a nationally representative survey of women who had given birth between July 2011 and June 2012 (n = 1960). We estimated the effect of having a suspected large baby (SLB) on the odds of six labor and delivery outcomes. RESULTS: Nearly one-third (31.2%) of women were told by their maternity care providers that their babies might be getting "quite large"; however, only 9.9% delivered a baby weighing ≥4000 g (19.7% among mothers with SLBs, 5.5% without). Women with SLBs had increased adjusted odds of medically-induced labor (AOR 1.9; 95% CI 1.4-2.6), attempted self-induced labor (AOR 1.9; 95% CI 1.4-2.7), and use of epidural analgesics (AOR 2.0; 95% CI 1.4-2.9). No differences were noted for overall cesarean rates, although women with SLBs were more likely to ask for (AOR 4.6; 95% CI 2.8-7.6) and have planned (AOR 1.8; 95% CI 1.0-4.5) cesarean deliveries. These associations were not affected by adjustment for gestational age and birthweight. CONCLUSIONS FOR PRACTICE: Only one in five US women who were told that their babies might be getting quite large actually delivered infants weighing ≥4000 g. However, the suspicion of a large baby was associated with an increase in perinatal interventions, regardless of actual fetal size.

Sunday, March 13, 2016

Once Again, Metformin Does Not Reduce Birthweight

One of the risks of "obesity" and pregnancy that care providers get most concerned about is big babies.

Although most high-BMI women have average-sized babies, they do have an increased rate of big babies on average and this tends to panic many providers.

Why all the concern? Most of the time, big babies have normal outcomes, but research is clear that they are more at risk for shoulder dystocia (shoulders getting stuck), as well as low blood sugar at birth and perhaps also cesarean section.

Because doctors frequently get sued for nerve damage caused by shoulder dystocia, they understandably are concerned when they suspect a woman might have a large baby. And because larger women tend to have larger babies on average, many care providers want to intervene in the pregnancies of women of size to try and prevent big babies.

Prophylactic metformin is just the latest intervention that care providers are using to try and reduce fetal size among high-BMI women.

Interventions for Big Babies

Traditionally, the most common intervention if a big baby is suspected is a planned cesarean or an induction "before the baby gets too big," even though most research does not support improved outcomes from either of these interventions. Indeed, there is substantial research to suggest poorer outcomes. Thus care providers have looked for other alternatives to reduce birthweight in the infants of high-BMI women.

The most popular intervention these days is to strictly limit the mother's prenatal weight gain. A high weight gain has been shown to be associated with more Large-for-Gestational-Age (LGA) babies, so it does make sense for women to be careful about what they eat and try to avoid large gains.

On the other hand, too-small gains are associated with increased risks of prematurity and Small-for-Gestational-Age (SGA) babies. Some research also suggests that very small gains and weight loss during pregnancy are associated with infant death, so it's important that care providers not go too far in limiting prenatal weight gain.

Many care providers try to reduce the number of large babies by pressuring women to lose weight before pregnancy. However, research clearly shows that few people lose weight long-term, and that even when weight is lost long-term, it is usually only a very small percentage of their weight. Rarely does a woman completely normalize her weight before pregnancy and keep it off successfully. So this tactic also has limited use, leading care providers to look for other possibilities.

Metformin to Reduce Birthweight

The most recent trendy "fix" for big babies has been to put high-BMI women, even those with normal glucose tolerance, on metformin (Glucophage). The theory is that many high-BMI women have blood sugar or insulin levels that are elevated but not high enough to be diagnosed with gestational diabetes. These "pre-diabetic" blood sugar levels and/or high insulin levels are thought to be what is causing the baby to grow larger.

As we have written about before, this is an interesting theory but one that is fraught with concerns. Most women of size don't have big babies; if you put them all on metformin as a preventative, what does this do to the majority who would have normal-sized babies? And does metformin use increase risks for other problems? For example, one meta-analysis shows an increased tendency towards pre-term birth with metformin. And we know that metformin tends to deplete B vitamin levels, especially B12 and folic acid. Could that cause birth defects or cause other problems? These are important questions that need to be answered.

In the meantime, the question of whether metformin "normalizes" fetal birth weights is being answered now. It does not.

One study from England recently found that giving metformin to obese women with normal glucose tolerance did NOT reduce fetal size. 

This new study seems to confirm those findings. Using metformin in women with a BMI over 35 but normal glucose tolerance did not reduce fetal size.

Those who promote scorched-earth intervention policies in the pregnancies of women of size will point out that the metformin use did lower the mother's weight gain. However, the difference was small; only about 5 lbs. or so. Is that really clinically meaningful, especially when it didn't change the baby's birthweight or much of anything else?

The one promising find was that metformin use did lower the rate of pre-eclampsia, from 11% to 3%. Since pre-eclampsia is a very serious complication, that is an interesting finding, and one that echoes a few other studies on metformin use.

However, this is balanced by the fact that most other studies have shown that metformin had little effect on pre-eclampsia rates. Indeed, there have been at least two studies that have found an increased rate of pre-eclampsia when metformin was used. So the question of its efficacy for reducing pre-eclampsia is still up in the air.

Nor did metformin use change the rate of gestational diabetes (GD) in this study, which you might expect it to have done. That casts even more doubt on its utility in non-diabetic obese women.

Another downside is that many women experienced side effects (usually G.I. issues like nausea, vomiting, and diarrhea) while taking metformin. Fifty women dropped out of the trial, presumably because of side effects like these. If taking metformin results in G.I. misery, women are simply not going to take it, so it doesn't really matter how effective it could be (or not). It has to be tolerable for those taking it.

Final Thoughts

This post might make people think I'm opposed to the use of metformin. I'm not.

I think metformin is a pretty amazing drug in many ways. It has an excellent safety profile, and an impressive record of improving health outcomes in people with diabetes. It does cause significant G.I. issues in some people so its utility is limited for those folks, but for those who can tolerate it, it's an extremely useful drug.

Nor am I opposed to the use of metformin in pregnancy─ when it is indicated, such as with GD and/or PCOS (Polycystic Ovarian Syndrome). The research shows it can be quite useful in those situations. 

However, in my opinion, across-the-board use of metformin on all obese women to prevent big babies or other complications is highly questionable. 

That doesn't preclude its use in a carefully monitored research setting, please note. If non-diabetic women of size have been given full informed consent about it and want to participate in a research study on its use, I'm okay with that. They get to decide for themselves whether they think participating in such a study is worthwhile. They should not be pressured or guilted into using it, but if they want to be a test subject then that's their right.

But routine use across the board in all non-diabetic obese women? Pressuring or guilting normoglycemic high BMI women into its use just because they might have a bigger baby? I think the results of these two studies clearly indicate that use is a massive overreach.

The good news is that this study provides further data that use of metformin in pregnancy seems to be reasonably safe. This is great for women with PCOS, type 2 diabetics, and women who develop GD; metformin seems to be clearly helpful in these groups.

The bad news is that it doesn't seem to be very helpful as a way to normalize fetal growth in non-diabetic women.

The bottom line is that care providers need to stop pushing the use of metformin as a way to prevent big babies in high BMI women. 


Reference

N Engl J Med. 2016 Feb 4;374(5):434-43.doi: 10.1056/NEJMoa1509819. Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus. Syngelaki A1, Nicolaides KH, Balani J, Hyer S, Akolekar R, Kotecha R, Pastides A, Shehata H. PMID: 26840133
BACKGROUND: Obesity is associated with an increased risk of adverse pregnancy outcomes. Lifestyle-intervention studies have not shown improved outcomes. Metformin improves insulin sensitivity and in pregnant patients with gestational diabetes it leads to less weight gain than occurs in those who do not take metformin. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned pregnant women without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of more than 35 to receive metformin, at a dose of 3.0 g per day, or placebo (225 women in each group) from 12 to 18 weeks of gestation until delivery. The BMI was calculated at the time of study entry (12 to 18 weeks of gestation). The primary outcome was a reduction in the median neonatal birth-weight z score by 0.3 SD (equivalent to a 50% reduction, from 20% to 10%, in the incidence of large-for-gestational-age neonates). Secondary outcomes included maternal gestational weight gain and the incidence of gestational diabetes and of preeclampsia, as well as the incidence of adverse neonatal outcomes. Randomization was performed with the use of computer-generated random numbers. The analysis was performed according to the intention-to-treat principle. RESULTS: A total of 50 women withdrew consent during the trial, which left 202 women in the metformin group and 198 in the placebo group. There was no significant between-group difference in the median neonatal birth-weight z score (0.05 in the metformin group [interquartile range, -0.71 to 0.92] and 0.17 in the placebo group [interquartile range, -0.62 to 0.89], P=0.66). The median maternal gestational weight gain was lower in the metformin group than in the placebo group (4.6 kg [interquartile range, 1.3 to 7.2] vs. 6.3 kg [interquartile range, 2.9 to 9.2], P<0.001), as was the incidence of preeclampsia (3.0% vs. 11.3%; odds ratio, 0.24; 95% confidence interval, 0.10 to 0.61; P=0.001). The incidence of side effects was higher in the metformin group than in the placebo group. There were no significant between-group differences in the incidence of gestational diabetes, large-for-gestational-age neonates, or adverse neonatal outcomes.  CONCLUSIONS: Among women without diabetes who had a BMI of more than 35, the antenatal administration of metformin reduced maternal weight gain but not neonatal birth weight. 

Sunday, March 6, 2016

Weight Loss In Pregnancy Doubles the Risk for Low Birth Weight Babies


Here is yet another study showing that weight loss during the pregnancies of "obese" women increases the risk for low-birth weight babies.

In this study, weight loss during pregnancy doubled the risk for a low-birth-weight baby. 

This is important because low-birth-weight babies are at increased risks for health problems as they get older, including insulin resistance, diabetes, abdominal fatness, metabolic syndrome, and cardiovascular disease. In the rush to "cure" obesity through restricted prenatal weight gain, are care providers increasing the next generation's risk for the very conditions they are trying to prevent?

Nor is this the first study to find an increased risk for small-for-gestational-age babies with gestational weight loss. It is only the latest of quite a few to find this. One recent systematic review concluded that Gestational Weight Loss "should not be advocated in general for obese women."

Yet there are still care providers who are pressuring women of size to lose weight during pregnancy. Care providers need to STOP promoting gestational weight loss as a goal for obese women. 

Side Notes and Cautions

A couple of cautions about the study. 

As we discussed before, there are women of size who naturally lose weight in pregnancy because their metabolism increases during pregnancy. This doesn't automatically mean a bad outcome, and no one should panic if they are losing weight without trying. Some women, especially those with higher BMIs, lose weight without restricting their nutrition and have perfectly fine outcomes. As long as you are eating well and baby seems to be growing adequately, it's not something to panic about. 

But deliberately trying to lose weight during pregnancy is a different story. The care providers who are pressuring women to lose weight during pregnancy by restricting their intake or eliminating food groups are putting babies at risk and this study confirms that. 

Care providers should NOT be counseling women to gain no weight or to lose during pregnancy. Previous research shows that this is particularly risky for women in the "overweight" (BMI 25-30) and "borderline" obese (BMI 30-35) groups. Some gain seems to be helpful, even if the overall gain in higher BMI women is lower than in other weight groups.

On the other hand, it is important to note that excessive weight gain also is associated with increased risks, most notably for a big baby. (It is also associated with higher rates of blood pressure issues in pregnancy, although this could simply be coincidental due to fluid retention.) 

This means that women of size should try to avoid a too-high gain if they can. However, plenty of high-BMI women have had higher gains and still had healthy outcomes. Like weight loss, a higher gain is not something to aim for, but it doesn't have to be something to panic over either, as long as nutrition is normal and healthy and baby seems to be growing along a normal curve.  

Moral of the story: High-BMI women have the best outcomes in pregnancy when they gain modestly...not too much but not losing either. 

However, a modest gain with good nutrition is different from manipulating weight gain deliberately by restricting calories. In my opinion, it's far better to focus on optimal nutrition than on trying to manipulate weight gain to meet arbitrary weight gain guidelines.

My Biggest Quibble

I am always disappointed that I have yet to see a prenatal weight gain study that focuses on the right issue ─ nutrition. Instead they use weight gain as a proxy for good nutrition, which is an erroneous thing to do. 

A person who gains 11-20 lbs. (the amount recommended for obese women by the Institute of Medicine guidelines) while eating a lot of junk food probably has a lot different outcome than one who gains the same amount from healthy proteins, whole grains, and a variety of fruits and vegetables. Both gains are the same, but the nutrition is very different. Instead of looking only at how much weight women gain, I'd rather they did a more qualitative investigation into what the women were consuming and how that influenced outcomes. 

I'd personally be a lot less worried about the woman of size who gains 30 lbs. while eating an excellent diet than one who gains 30 lbs. from eating Twinkies and ice cream. I'd also be a lot less worried about one who loses weight in pregnancy while eating a healthy diet with plenty of calories than one who loses weight by drinking Slim-Fast to limit her weight gain. (Yes, sadly, that's a real recommendation from a real doctor.)

Rather than obsessing over weight gain, care providers would do better to focus on the quality of the mother's nutrition rather than obsessing so much about the numbers on a scale. 

Reference

J Perinatol. 2016 Jan 7. doi: 10.1038/jp.2015.202. [Epub ahead of print] Maternal and neonatal outcomes in obese women who lose weight during pregnancy. Cox Bauer CM1, Bernhard KA2,3, Greer DM2,3, Merrill DC1. PMID: 26741574
OBJECTIVE: To evaluate neonatal and maternal outcomes in obese pregnant women whose weight gain differed from the Institute of Medicine (IOM) recommendations. STUDY DESIGN: Maternal and neonatal outcomes associated with weight change in pregnancy were retrospectively investigated in women with obesity (body mass index (BMI) ⩾30 kg m-2; N=10734) who gave birth at 12 hospitals. Using a 1:1:1:1 design (n=778 matched groups), we matched women with obesity who lost, maintained, gained appropriate (IOM recommended) and gained excessive weight during pregnancy by gestational age at delivery, maternal age, race/ethnicity, prepregnancy BMI, chronic hypertension, pregestational diabetes and smoking status. Regression techniques were used to adjust for confounders and compare outcomes across weight change categories. RESULT: Compared with IOM recommendations, weight loss was associated with twofold greater odds of low birth weight infants and a mean decrease in estimated blood loss of 30 ml; excessive weight gain was associated with doubled odds of gestational hypertension or preeclampsia, fourfold greater odds of macrosomia and a mean decrease in 5-min APGAR of 0.09. From lost to excessively gained weight, the odds of cesarean delivery increased 1.4 times and mean infant birth weight increased by 197 g. In contrast, the odds of small-for-gestational age were 1.8 times greater for women who lost than gained excessive weight. CONCLUSION: Weight loss in obese pregnant women is associated with increased risk for low birth weight neonates but significantly decreased or maintained risk for other maternal and neonatal morbidities, as compared with appropriate or excessive weight gain. This study supports re-evaluation of the current IOM guidelines for women with obesity.