The vast majority of women with epilepsy are able to get pregnant, with relatively few issues, new research shows.
“There has been the notion and some evidence in the past that fertility is reduced in women with epilepsy compared with the general population, but what these findings suggest is that 90% of women with epilepsy can get pregnant,” study investigator Andrew G. Herzog, MD, professor and director, Neurology, and Neuroendocrine Unit, Beth Israel Deaconess Medical Center, Wellesley, Massachusetts, told Medscape Medical News
The study was presented here at the American Epilepsy Society (AES) 72nd Annual Meeting 2018.
The researchers used retrospective data from a web-based epilepsy birth control registry. Any woman with epilepsy can complete the online survey and get educational materials on safe and effective contraception.
From this registry, researchers had reproductive data on 978 women aged 18-47 years with epilepsy. This included demographic, epilepsy, anti-epilepsy drug (AED), contraceptive, and reproductive data.
The investigators analyzed three outcomes:
Infertility rate: The percentage of women who had unprotected sex but did not achieve pregnancy after 1 year.
Impaired fecundity rate: The percentage of women who were infertile or did not carry a pregnancy to live birth, excluding abortions.
Live birth rate: The percentage of pregnancies that resulted in live births, excluding abortions.
A total of 411 women attempted to become pregnant. Of this group, 373 had 724 pregnancies resulting in 445 live births.
The mean age at pregnancy was 24.9 years, but women who became pregnant ranged in age from 14 to 44 years.
Some 72.6% of the women had a live birth at first pregnancy and 89.0% had at least one live birth in their first two pregnancies.
Of the 411 women, 38 tried but were unable to become pregnant at the end of 1 year, for an infertility rate of 9.2% (95% CI, 6.7 – 12.4). In contrast, the infertility rate among the general population is 6.4%, as estimated by the Centers for Disease Control and Prevention (CDC).
About 20.7% of the women had impaired fecundity, which included the 38 individuals who were infertile and 46 pregnancies that did not result in a live birth.
Impact of AEDs Unclear
Investigators also examined the potential impact of AEDs on fertility. They compared no AED to monotherapy and polytherapy, and no AED to specific classes of AED, including enzyme-inducing, non-enzyme-inducing, enzyme inhibitory, and glucuronidated drugs.
They found that for women on any AED, the rate of infertility was twice that of those not taking an AED (10.3% vs 4.2%), although the sample sizes in this interim analysis were too small to be statistically significant, said Herzog.
Devon MacEachern, BS, who presented the data at a Platform Session during the meeting, said the study would need more than double the participants in the any AED category for the study to be adequately powered to make meaningful conclusions about the potential impact of AEDs on fertility.
The impaired fecundity rate was also almost two times greater for women on any AED than for those not taking an AED (22.2% vs 13.9%; relative risk [RR], 1.79; 95% CI, 0.94 – 3.11; P = .08).
Comparisons of various individual monotherapies to polytherapy were not significant.
In addition, the live birth rate was similar for women on any AED (73.9%) compared with those not taking an AED (79.1%).
However, when investigators examined the impact of specific drugs on fertility, the analysis showed that women on lamotrigine had a significantly higher live birth rate than their counterparts on valproate (89.1% vs 63.3%; RR, 1.41; 95% CI, 1.05 – 1.88; P = .02).
Physicians have numerous issues to discuss with their female patients with epilepsy during office visits. These include seizure management, safety and risks of individual AEDs, as well as contraception, which is “often not adequately addressed,” said Herzog.
A limitation of the study is that the information was self-reported. Also, the women who completed the registry surveys were younger and better educated than the general population, and minority women were under-represented.
Following MacEachern’s presentation, one delegate asked whether the fertility of the women’s partners may have contributed to fertility failure rates.
The “downfall” of this study, and of a CDC general population study, is that they don’t determine whether the male or female contributed to the infertility, she said.
Good News for Patients
Commenting on the study for Medscape Medical News, session co-chair, Kelly Knupp, MD, Pediatric Neurology and Epilepsy Program, Children’s Hospital Colorado, said the results are “good news” for patients.
“The fear of many teenage girls with epilepsy is that they can’t have babies.”
The higher infertility rate among women with epilepsy uncovered by the study is something “we worry about in terms of what that means in a bigger population and something [physicians] have to be cognizant of.”
However, as information in the database is self-reported, “we have to be a little cautious because it doesn’t represent the entire population,” she said.
Appropriate management of pain during and after pregnancy is essential to minimise the risk of adverse outcomes to mother and baby, but the type and timing of pain relief is important, a new review said.
A team of leading doctors carried out the review for the Royal College of Obstetricians and Gynaecologists (RCOG) following concerns over the use of codeine during breastfeeding.
It recommended that, where possible, all drugs should be avoided during the first trimester because the embryo is most vulnerable to teratogenic effects between 4 to 10 weeks gestation. However, it acknowledged that some would need to be continued to prevent maternal harm.
It found that paracetamol “remains the analgesic of choice” in pregnant and breastfeeding women because of its excellent safety record, although it noted limited associations between the use of paracetamol and adverse outcomes including an increased incidence of childhood asthma, behavioural problems, and a delay in gross motor and communication development in children with long‐term antenatal exposure.
The review said that nonsteroidal anti-inflammatory drugs (NSAIDS) – such as ibuprofen – should be avoided unless clinically indicated, such as for a severe migraine, within the first trimester and should not be taken after 30 weeks of gestation due to increased risk to the baby.
The reviewing doctors recommended the lowest effective dose for the shortest time because of some evidence that the use of NSAIDS might increase the risk of first-trimester miscarriage.
However, NSAIDS were safe to use during breastfeeding, they said, as the quantity of drug that passed into milk was very small.
The guidelines said that opioid analgesics, such as codeine, tramadol, dihydrocodeine (DHC), and morphine should be avoided wherever possible and only administered by a health professional.
However, it highlighted the important difference between codeine and DHC during breastfeeding and emphasised that DHC was safer to take during breastfeeding, whereas codeine should be avoided, because of increased concerns regarding toxicity.
Dr Dina Bisson, a consultant obstetrician who led the review, said: “It is absolutely essential that pain is managed appropriately during pregnancy and breastfeeding. Many women may develop headaches, lower back pain and pelvic pain during pregnancy and breastfeeding, while others may have chronic conditions, where pain management is necessary.
“If pain is not adequately managed, this can have a negative impact on a woman’s physical and mental wellbeing.
“Women should be encouraged to try non-medical treatments, such as adequate rest, hot and cold compresses, massage, physiotherapy, and exercise. But if pain relief drugs are required, it is important that doctors and midwives are able to advise on appropriate medication and hopefully this review will be helpful.”
The RCOG said it was concerned by reports that fewer pregnant women were having a flu vaccine this year. Public Health England said this week that only around 40% of pregnant women have had the vaccine so far this season.
Dr Pat O’Brien, a consultant obstetrician and spokesperson for the RCOG, said: “Flu can occasionally be serious for pregnant women as it increases risk of complications, such as bronchitis, a chest infection that can develop into pneumonia.
“The best way to avoid getting this is to have the flu vaccination. Women who are pregnant should be reassured that current evidence shows the flu vaccine is safe to use.”
I have observed natural childbirth to be a topic of a lot of heated debates online. One camp, to which I belong, prefers to do it “the way nature intended,” without pain killers and interventions, and another camp wonders, understandably, why not use the methods of pain management that civilized humanity has come up with. Because labor is definitely not a walk in the park.
While my plan to have a natural, unmedicated childbirth was based fully on following my intuitive nudge, I decided to dig deeper and list some more legit reasons to consider a natural approach.
Here are the top 10 reasons to consider a childbirth without the epidural.
1. The Array Of Possible Side-Effects
The epidural is usually a safe procedure, but the quantity of possible side-effects is frightening: low blood pressure (most common), loss of bladder control, itchy skin, sickness, backache, severe headaches, infection, epidural haematoma, convulsions, breathing difficulties, nerve damage, death. (Source)
2. Epidurals Interfere With The Important Cocktail Of Birth Hormones
Hormones play a huge role in labor. Estrogen and progesterone initiate labor. Oxytocin is the initiator of the rhythmic contractions of early labor, and oxytocin produced by the fetus directly stimulates mother’s uterine muscle, prevents postpartum hemorrhage after birth, and mediates the milk-ejection-reflex. Beta-endorphin increases tolerance to pain and shifts consciousness to “another place,” frequently described by labouring mothers. Prolactin prepares a pregnant woman’s breasts for lactation. Catecholamines (the “fight-or-flight” hormones, epinephrine and norepinephrine) gradually rise, peaking right before transition, and initiate the Fetus Ejection Reflex. If the natural increase of CA levels that should occur later in labor is blocked (by painkillers or other drugs), then the fetal ejection reflex will not be stimulated and delivery may be more difficult. Epidurals prevent the production of beta-endorphins, which in turn makes it harder for a laboring woman to cope with pain and go to that “other place” women describe. Epidurals also reduce oxytocin production and prevent its levels from rising during labor. They also prevent the peak of oxytocin from happening during birth, as the stretching receptors of a woman’s lower vagina that trigger it are numb. Read more in-depth on hormones during labor in this amazing article.
3. Epidurals Lengthen Labour
The 2002 study concluded that epidurals are associated with longer second-stage labor (the painful one!!!), but not the first stage. (Source)
4. Epidurals Increase The Rate Of Pelvic Floor Problems After Delivery
To be detailed – urinary, anal, and sexual disorders. The prospective study concluded that a second stage longer than one hour (a frequent occurrence with the use of epidural as we saw in the previous point) is associated with the development of postpartum urinary incontinence (loss of bladder control), which is rarely resolved spontaneously.
5. Epidural Triples The Risk Of Severe Perineal Tear
The study of 2,759 women giving birth to babies after 36 weeks gestation in St. Francis Regional Medical Center concluded that epidural analgesia more than tripled the risk of severe perineal injury. Out of 2,759 women 634 had epidurals (65 of them had severe tears) and 2,125 did it naturally (and only 111 of them teared). Those are pretty impressive numbers. Read full study review here.
6. Drugs Administered By An Epidural Enter Baby’s Bloodstream
Moreover, since their immune system is very immature, it takes them way longer to eliminate them from their system. For example bupivacaine, a commonly used epidural analgesic, stays in your baby’s bloodstream for at least 8 hours (compared to 2.7 hours in yours).
7. Epidurals Compromise Fetal Oxygen Supply, Resulting In Fetal Acidemia
Fetal acidemia is a medical term referring to the high acidity of an unborn baby’s blood. It typically occurs when a fetus is deprived of oxygen for a period of time during or after delivery. Sometimes it can lead to complications, such as brain damage, or even infant death. This study shows that the frequency of fetal acidemia (pH less than 7.10) was significantly increased in the spinal-anesthesia group and in the epidural group compared with the general-anesthesia group. Read the full report here.
8. It Increases The Necessity Of Cesarian Section By 2.5 Times
The study of 711 women who carried to term and had a spontaneous onset of labor showed that, out of 447 who received epidurals, 10.3% received cesarian sections, and out of 264 women who did not receive the epidural analgesia, only 3.8% ended up with the C-section. That is a pretty big difference. Here is the full summary of the study.
9. Baby Is Less Alert & Has Less Ability To Orient
This study showed that immediately after delivery, infants with greater exposure to bupivacaine (drug administered in Epidural) in utero were more likely to be cyanotic (having a blue or purple tint of skin associated with low oxygen saturation) and unresponsive to their surroundings. Visual skills and alertness decreased significantly with increases in the cord blood concentration of bupivacaine, particularly on the first day of life but also throughout the next six weeks. And if you are planning to breastfeed, this is major news, as you want your baby alert in order to latch within the first hours when the sucking instinct is the strongest.
10. It Is Important To Feel Labour Pain
I know this one is hard to wrap your mind around, but hear me out. In my opinion, pain during labor teaches a woman two of the most important virtues of motherhood: acceptance and surrender.
There’s a lot about being a mother, especially of a very young infant, that one would have to accept. Without judgement, without resentment, just for what it is. I am talking about numerous sleepless nights and days, and months, and more months; crying for seemingly no reason, sometimes for hours, sometimes rejecting your comfort and help, being bathed in your own tears; not being perfect no matter how hard you might try; changes in your life, in all areas of it, even the ones you did not expect. Surrender to pain during labor is like surrendering your control to God, to the flow, to nature, and allowing what needs to take place to do so, regardless of your level of comfort or satisfaction with the process. I believe that in this surrender begins your journey of motherhood, and that with accepting your pain, you accept this honorable title. Here is one more amazing piece on the power and purpose of pain during labor by Judith A. Lothian. She could not have described it any better.
I hope this article brought you more clarity about what labor is like, what physical processes are happening, and how the use of an epidural can inhibit the perfect natural course of events. And on the ending note, whether you decide to give birth naturally or not, here is to a fast and easy labor and healthy, happy babies ❤
Do you know any more reasons to consider a natural childbirth? Let’s talk in the comments below.
As a medical student, one of the conditions that was hardest for me to get my head around was PCOS (polycystic ovarian syndrome). It took me several years of advanced training to understand the ins and outs of the syndrome.
PCOS is a complex hormonal condition that involves multiple organs systems. It’s is a clinical diagnosis, meaning that doctors diagnosis patients with PCOS based on symptoms – not on a specific lab test that is “positive of negative” for the condition. PCOS is diagnosed if a woman has two or more of the following symptoms:
Signs of too much male hormone (excess dark hair growth on chin, cystic acne or elevated testosterone on blood tests)
Menstrual cycles > 35 days apart
Enlarged ovaries on ultrasound
As hard as it was to grasp in med school, and as challenging as it is to explain it to my patients in a 10-minute office visit, it’s not surprising that there are a lot of misunderstandings about PCOS floating around.
Myth #1 “PCOS is caused by your ovaries”
PCOS is caused by a full body hormonal miscommunication – the actual polycystic ovaries are merely a symptom. There are many different metabolic issues going on that contribute to PCOS. The brain sends the ovary mixed signals causing it to secrete excess male hormones, which affects the delicate fluctuations of female hormone that trigger ovulation. At the same time, fat cells contribute to the problem by resisting insulin, triggering the body to make excess insulin when carbs are eaten. This insulin increase not only prompts the ovary to produce too much male hormone, but also causes weight gain. The ovaries can’t manage to ovulate because the hormones are all wrong.
Myth #2 “Women with PCOS are infertile”
Women with PCOS can have difficulty getting pregnant, but the infertility associated with PCOS is often easy to treat. Women who have PCOS and are overweight can often begin to ovulate regularly with very modest weight loss of even 10% of their body weight. Medication can also help; 50% of women with PCOS will conceive with clomiphene treatment (an inexpensive ovulation-inducing pill). Of women who conceive on clomiphene, the majority conceive within 4 months, so it should not be taken for an extended amount of time.
Myth #3″PCOS causes pain”
During a normal menstrual cycle, the chosen egg of the month begins to grow within a small follicle cyst on the ovary. When ovulation occurs, the egg escapes the cyst and makes a run for the fallopian tube, and its former cyst usually dissolves over time. In PCOS the ovaries are trying to ovulate but because of the body’s confused hormones, the ovulation cyst gets stuck and is unable to fully develop to the point it can spit out the egg, hence the ovary becomes swollen with underdeveloped cysts. These cysts cause the ovaries to become enlarged, but the cysts do not usually rupture or cause pain.
Myth #4 “Women with PCOS are overweight”
PCOS is often associated with obesity, but not always. At one time, PCOS was defined as having all three symptoms plus obesity, but we now recognize that there are different “types” of PCOS. You only need two of the three symptoms of PCOS to have the condition. The treatment of PCOS is based on the sub-type and your goal (for example, birth control pills do an excellent job of controlling the irregular cycles and treating the abnormal male hormone of PCOS, but would not be the best option for someone try to conceive). For overweight PCOS patients, a low carb diet with regular exercise is recommended. (My personal recommendation is the nutrition plan in The Obesity Code by Dr. Jason Fung)
Myth # 5 “PCOS patients have very high risk pregnancies”
I often have patients worry that since PCOS makes it challenging to get pregnant, it will also put them at super high risk during pregnancy. Once pregnant, PCOS patients are at an increased risk of gestational diabetes and high blood pressure, but most go on to have normal pregnancies. They do not have an increased risk of miscarriage as previously thought.
Around 10% of women meet the criteria for PCOS worldwide and our understanding of the condition and treatments has evolved over the last 20 years. If you have symptoms of PCOS, don’t get discouraged by the myths. Instead, talk to doctor about customized treatment of your condition.
For many practitioners of in vitro fertilisation (IVF) today, it must be hard to comprehend the disdain and disgust with which the introduction of IVF as a therapy for infertility was greeted. The ethical and legal wrangling about human reproductive cloning and the current debate over trans‐generational (germline) genome editing gives a small flavour of how IVF was seen then. What was regarded as an irrelevant, disruptive, and unethical practice is now effectively mainstream treatment in most countries of the world.
The journey from bench to bedside was fraught with difficulties – both technical and social.1 It took almost 10 years from the proof of principle of IVF in Robert Edwards’ Cambridge laboratory to the first live birth 40 years ago in Oldham, UK, achieved by Edwards, Steptoe, and Purdy. To be an IVF parent then was considered too shameful to admit, to be an IVF child was to be considered a freak, and to be an IVF practitioner or to be conducting embryo research led to one being likened to Frankenstein or Dr Mengele. Indeed, when Edwards and Steptoe applied for a Medical Research Council (MRC) grant to fund their work in 1971, they received entirely hostile referees’ reports,2 suggesting that the referees either did not believe that IVF was able to solve the problem of infertility or that it was not a problem worth solving. Despite these funding setbacks, the hostile social environment in which they worked, and the many technical problems that they had to overcome, they pressed on undaunted, buoyed up largely by the many letters that they received from people suffering with infertility and the willing supply of patients that came to their Oldham clinic. The hostile social and professional environment was such that, even after the births of Louise Brown in 1978 and Alistair Montgomery in 1979, the situation for Edwards, Steptoe, and Purdy did not improve. As Steptoe had to retire from his NHS post in Oldham, they sought support from the NHS and the University in Cambridge to continue the work there, but were unsuccessful, and were forced to relocate and adapt a private clinic at Bourn Hall, which set them back 2 years. During this hiatus, the Australian clinics in Melbourne took the lead, only to be hampered themselves by the same social abreaction in the form of state legislation that restricted their capacity to undertake research on human embryos. Edwards, Steptoe, and Purdy started taking patients at Bourn Hall in 1982, the same year that the Government set up a committee of enquiry into IVF chaired by Mary Warnock. This committee reported in 1984 and recommended the setting up of a Human Fertilisation and Embryology Authority (HFEA), to oversee treatment and research using human embryos. The HFEA finally came into existence in 1990 after a prolonged struggle to salvage embryo research from initially very hostile houses of parliament.3
Efficacy and safety
Despite the fact that we have much to celebrate regarding the introduction of IVF, it is clear that the efficacy of the technology, despite continuing improvement, remains limited (can you imagine any other branch of medicine or surgery accepting and working with a 70% failure rate?), and its safety is still not fully demonstrated: being live born is not the same as being a healthy adult. Potential epigenetic effects of superovulation, culture conditions, media constituents, and embryo or gamete manipulation have never been studied in the long term,4 and only a few have been studied in the short term. In the early days of IVF, neither the MRC nor the Department of Health thought IVF important enough to consider long‐term follow‐up for babies, and still only scant information about health follows the various registers internationally. At least intracytoplasmic sperm injection (ICSI) was followed up strictly after its introduction in Belgium, and some pre‐implantation genetic diagnosis (PGD) centres still follow the children that they have helped to be born free of genetic disease.
Multiple embryo transfer
Increasing evidence has accumulated from well‐designed studies about the disadvantages and risks of multiple embryo transfer, not only in terms of prematurity with a multiple birth, but also the effects of vanishing twins that may accompany the transfer of more than one embryo.5 There is still a general reluctance to move wholly to single embryo transfer, However; the success of embryo vitrification is likely to change this, although evidence of its long‐term safety is still being collected.
Previously, this was undertaken as a last resort in the face of ageing and a lack of a partner, and was thus too late to be really effective.6 The freezing of oocytes as natural insurance against the reduction of fertility with ageing and against the increased risk of adverse genetic outcomes with age is a recent change in practice, and the demand for this is likely to increase further, especially if the legal time limit of 10 years for storage can be relaxed.
Pre‐implantation genetic screening and other new technologies
The debate about pre‐implantation genetic screening for aneuploidy (PGS/PGT‐A) has raged for nearly 25 years, with few good controlled studies, and with little prospect that any well‐designed trials with current genetic technologies will be undertaken, despite the opportunities for doing so.7 It seems that priority is given to making a healthy profit by offering new techniques to vulnerable patients rather than first establishing that the techniques are efficacious and safe. Indeed, the paucity of randomised studies and proper prospective follow‐up when new technologies are introduced is a sad hallmark of the IVF profession today. Is it not time that our professional societies and colleges stood firm on the need for sound scientific rationale, together with an insistence on proper studies and follow‐up, before allowing or supporting the application of new techniques? Is the absence of such careful studies a consequence of the largely private treatment of IVF in the UK and the USA? And might the lack of mandatory guidelines from the National Institute for Health and Care Excellence (NICE), leading to the postcode lottery in the provision of IVF on the NHS, be responsible for this unfortunate situation?
Role of the HFEA
There are many in the UK who still baulk at the Human Fertilisation and Embryology Act (HFE Act), through which the regulation of assisted reproduction occurs, because of a perception that it has been a brake on research and innovative practice. It is noteworthy, however, that the presence of such regulation has enabled the reasonably smooth public and legal acceptance of the most recent reproductive technology: mitochondrial replacement therapy (MRT) for inherited mitochondrial disease.8 The introduction of MRT here in the UK will be accompanied by the mandatory long‐term follow‐up of offspring (with parental consent). Although not the first country to undertake MRT, the first case in the USA received significant legal and ethical criticism for its lack of transparency and lack of proper follow‐up and oversight.9 Moreover, the rapid extension of MRT from avoidance of genetic disease to infertility therapy in some unregulated countries, despite the lack of any real scientific basis, gives cause for concern.
The study of the biology and role of mitochondria in development is blossoming, and improvement in cell culture and stem cell technology is allowing us to begin to understand the processes leading up to gastrulation, which can now be studied effectively in vitro for the first time.10 All of this has been achieved within the window of 14 days of development set out as a legal limit by the HFE Act; this limit has been followed by some other countries, but not by all. Thus, up to now the Act does not seem to have been a constraint on good laboratory research, including that of the genome editing of embryos.11 The need to know more about the later post‐implantation stages, such as gastrulation and germ cell formation, and the mechanisms governing reproductive success or failure, is likely to reopen public and legal discussion about the 14‐day rule: a pragmatic red line drawn up as a compromise between public concern and scientific imperative.
The future for this specialty is likely to be just as interesting and controversial as the previous 50 years because of its intimate involvement with the reproductive process and the health of future generations. Indeed, perhaps the biggest changes that the future brings will not be technological but social and ethical, with yet further challenges to our established ways of thinking about sex, gender, sexuality, reproduction, pregnancy, and the family. IVF has already contributed to massive social change and promises to lead to even more! Although the use of artificial intelligence (AI) and robotics will no doubt make its impact in assisted reproductive technology (ART) diagnosis and the IVF laboratory, as it has in diagnostic radiology and repetitive delicate assembly tasks, it is genome editing in human reproduction that is probably going to be the most controversial topic in biology for the foreseeable future. The possibility of editing embryos to remove harmful mutations, or creating gametes in vitro from cell lines that have undergone genome editing, challenges our ethical prejudices and our duties and responsibilities to future generations.12 PGD [or Preimplantation Genetic Testing for Mutation (PGT‐M), as we currently know it] may no longer be necessary once this new technology becomes efficacious and safe,13 and the number of embryos that would be available to be replaced or frozen would be significantly improved over the current use of PGD, which is wholly dependent on finding the unaffected embryos amongst a small developing cohort. Genome editing in this context might therefore be regarded as more ethical than PGD, as it would result in the destruction of fewer embryos.
In the future, selection for genetic traits compatible with environmental changes that are happening to our planet may become essential for the survival of our species, although, for the time being, this remains in the world of science fiction.
Since its early days as a pariah of clinical and research practice, IVF has come to occupy a central place in reproductive medicine. With the award of the Nobel Prize to Bob Edwards in 2010, its important role in science and medicine has now been recognised. Despite this recognition, IVF still retains elements of controversy in its present practice and future prospects, presaging of yet more battles to be fought, both nationally and internationally.
Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.
The recall is limited to specific lots of U by Kotex® Sleek® Tampons, Regular Absorbency, that were manufactured between October 7, 2016 and October 16, 2018 and distributed between October 17, 2016 and October 23, 2018. Consumers can identify this product by looking for specific lot numbers found on the bottom of the package. A full list of recalled lot numbers is available on the U by Kotex® website. Retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores.
No other U by Kotex-branded products are subject to this recall.
Kimberly-Clark has received reports from consumers of the U by Kotex® Sleek® Tampons, Regular Absorbency, unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.
Any consumer with the impacted U by Kotex® Sleek® Tampons, Regular Absorbency, in their possession should stop using the product immediately and promptly contact Kimberly-Clark’s Consumer Service team at 1-888-255-3499 between 7:30 a.m. – 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. Consumers who experience vaginal injury, (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot flashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.
Daily supplements of vitamin C might mitigate some of the harm to fetal lung development from smoking during pregnancy, according to a study.
At 3-months of age, infants born to pregnant smokers who took 500
mg/day of vitamin C in addition to a standard prenatal vitamin had
significantly better lung function by some measures of forced expiratory
flow (FEF) than did babies born to smokers randomized to receive
placebo instead of the vitamin C.
At 3-months of age, infants whose mothers took the vitamin C supplements had better FEF50 (436.7 vs 408.5 mL/sec, P=0.02) and FEF25-75 (387.4 vs 365.8 mL/sec, P=0.04).
However, the trial missed the primary endpoint of improving FEF75 (200.7 vs 188.7 mL/sec, P=0.10),
a flow obtained from the same expiratory curve as the other measures,
Cindy McEvoy, MD, of the Oregon Health & Science University in
Portland, and colleagues, reported in the American Journal of Respiratory and Critical Care Medicine.
An earlier study had shown vitamin C supplementation protective in a
group of newborns (72 hours old) born to women who smoked during
pregnancy. But that study used passive measures to assess lung function,
lead researcher McEvoy told MedPage Today.
The first focus of the clinician caring for pregnant smokers is to
try to convince them to give up the habit, McEvoy stressed. But, she
added, the reality is that many women can’t or won’t stop smoking during
It is estimated that around 10% of pregnant women in the U.S. smoke
during pregnancy, and in some populations the percentage is as high as
30% or 35%, she said.
“Many of the women in our study started smoking at really young
ages,” she said. “Pregnant smokers tend to come from more disadvantaged
populations and they tend to have more comorbidities. Some of (the
mothers in the study) also had other addictions that they were focusing
on overcoming. They would have liked to quit smoking, but there is only
so much you can do.”
Throughout the randomized trial, the pregnant participants received
smoking cessation counseling, and about 10% quit smoking during the
The double-blind, placebo-controlled trial was conducted at three
centers and included 251 pregnant smokers randomized at 13 to 23 weeks
of gestation to vitamin C (500mg/day) or to placebo.
Current smoking was defined as smoking one or more cigarettes during the prior week.
Outcomes included FEF75 at 3 months of age performed with the raised volume rapid thoracic compression technique, FEF50 and FEF25-75 obtained from the same expiratory curves.
Infant FEFs were
associated with the genetic variant α5 nicotinic acetylcholine receptor
(α5 nAChR) that appeared to amplify the negative impact of nicotine on
babies. The genetic variant has been linked to an increased risk for
lung cancer and obstructive lung disease in other studies.
“This confirms and expands our initial study of improved newborn PFTs
with similar findings but in a larger population with increased
diversity through the measurement of FEFs, a more specific measurement
of airway function. We also confirm our previous findings of the
importance of the α5 nAChR in the effect of in-utero smoke on pulmonary
function,” she said.
McEvoy told MedPage Today that the findings support the
hypothesis that oxidative mechanisms are, at least in part, responsible
for the effects of in-utero nicotine on lung development.
At randomization, both groups of pregnant smokers in the study had
levels of fasting ascorbic acid of 49 μmol/L that were decreased
compared to levels reported for nonsmoking women (58 μmol/L), consistent
with the increased oxidative load associated with smoking.
Pregnant women randomized to the supplemental vitamin C had
significantly increased fasting ascorbic acid levels at 26 and 32 weeks
of gestation when compared to baseline similar to levels typically
reported in nonsmoking women.
Uterine cancer is one of the few cancers with increasing incidence and mortality.
What is added by this report?
During 1999–2015 and 1999–2016, uterine cancer incidence and
mortality rates increased 0.7% and 1.1% per year, respectively, with
black women disproportionately affected.
What are the implications for public health practice?
Health care providers and community programs can help women achieve
and maintain a healthy weight and get enough physical activity, which
can reduce the risk for endometrial cancer, the most common uterine
cancer. Promoting awareness of the need for timely evaluation of
abnormal vaginal bleeding (between periods, after sex, or after
menopause), an important symptom of uterine cancer, increases the chance
for early detection and treatment.
Uterine cancer is one of the few cancers with increasing incidence
and mortality in the United States, reflecting, in part, increases in
the prevalence of overweight and obesity since the 1980s (1). It is the fourth most common cancer diagnosed and the seventh most common cause of cancer death among U.S. women (1).
To assess recent trends in uterine cancer incidence and mortality by
race and ethnicity, CDC analyzed incidence data from CDC’s National
Program of Cancer Registries (NPCR) and the National Cancer Institute’s
Surveillance, Epidemiology, and End Results (SEER) program and mortality
data from the National Vital Statistics System (2). Most recent
data available are through 2015 for incidence and through 2016 for
mortality. Uterine cancer incidence rates increased 0.7% per year during
1999–2015, and death rates increased 1.1% per year during 1999–2016,
with smaller increases observed among non-Hispanic white (white) women
than among women in other racial/ethnic groups. In 2015, a total of
53,911 new uterine cancer cases, corresponding to 27 cases per 100,000
women, were reported in the United States, and 10,733 uterine cancer
deaths (five deaths per 100,000 women) were reported in 2016. Uterine
cancer incidence was higher among non-Hispanic black (black) and white
women (27 cases per 100,000) than among other racial/ethnic groups
(19–23 per 100,000). Uterine cancer deaths among black women (nine per
100,000) were higher than those among other racial/ethnic groups (four
to five per 100,000). Public health efforts to help women achieve and
maintain a healthy weight and obtain sufficient physical activity can
reduce the risk for developing cancer of the endometrium (the lining of
the uterus), the most common uterine cancer. Abnormal vaginal bleeding,
including bleeding between periods or after sex or any unexpected
bleeding after menopause, is an important symptom of uterine cancer (3).
Through programs such as CDC’s Inside Knowledge* campaign, promoting
awareness among women and health care providers of the need for timely
evaluation of abnormal vaginal bleeding can increase the chance that
uterine cancer is detected early and treated appropriately.
Data on new cases of invasive uterine cancer†
diagnosed during 1999–2015 were obtained from population-based cancer
registries affiliated with NPCR and SEER. Data from all registries met
data quality criteria for U.S. Cancer Statistics§ in 2015, and data from 48 states met these criteria each year during 1999–2015, covering 98% of the U.S. population.¶
Uterine cancers were classified by histologic type (endometrioid
carcinoma, other carcinoma, carcinosarcoma, and sarcoma).** Stage at
diagnosis (localized, regional, distant, or unknown) was characterized
using SEER Summary Stage.†† Data on uterine cancer deaths
during 1999–2016 were based on death certificate information reported to
state vital statistics offices and compiled into a national file
through the National Vital Statistics System, covering 100% of the U.S.
population. Data were examined by five mutually exclusive racial/ethnic
groups: white, black, non-Hispanic American Indian/Alaska Native
(AI/AN), non-Hispanic Asian/Pacific Islander (API), and Hispanic; as
well as by histologic type, stage at diagnosis, and year of diagnosis or
Population estimates for rate denominators were a modification of
annual county population estimates by age, sex, bridged-race, and
ethnicity produced by the U.S. Census Bureau in collaboration with CDC’s
National Center for Health Statistics and with support from the
National Cancer Institute.§§ Annual incidence and death rates
per 100,000 women were age-adjusted to the 2000 U.S. standard
population. Average annual percent change (AAPC) was used to quantify
changes in incidence rates during 1999–2015 and death rates during
1999–2016 and was calculated using joinpoint regression, which allowed
different slopes for three periods; years at which slope changed could
vary.¶¶ To determine whether AAPC was significantly different
from zero, a t-test was used for zero joinpoints, and a z-test was used
for ≥1 joinpoint. Rates were considered to increase if AAPC >0
(p<0.05) and to decrease if AAPC <0 (p<0.05); otherwise rates
were considered stable. All statistical tests were two-sided.
In 2015, 53,911 new microscopically confirmed uterine cancer cases,
corresponding to 27 cases per 100,000 women, were reported in the United
Uterine cancer incidence was higher among white women and black women
(27 cases per 100,000 in each group) compared with AI/AN and Hispanic
women (23 each) and API women (19). Overall, endometrioid carcinomas
were the most common uterine cancers (68%). However, endometrioid
carcinomas accounted for 47% of uterine cancers among black women, who
had a higher percentage of other carcinomas, carcinosarcomas, and
sarcomas than did women in other racial/ethnic groups. Approximately two
thirds of uterine cancers were diagnosed at a localized stage among
white (69%), AI/AN (68%), API (67%), and Hispanic women (66%), compared
with 55% among black women. A higher proportion of sarcomas were
diagnosed at distant stage (36%) than were endometrioid carcinomas (3%),
other carcinomas (18%), or carcinosarcomas (22%). The proportion of
uterine cancers diagnosed at distant stage was higher among black women
than among women of other racial/ethnic groups, overall (16% versus
8%–10%) and for each histologic type, particularly sarcoma (45% versus
During 1999–2015, uterine cancer incidence rates increased 12%, about
0.7% per year on average, with larger increases observed among AI/AN
(53%; AAPC = 2.7%), black (46%; 2.4%), API (38%; 2.0%), and Hispanic
(32%; 1.8%) women than among white women (9%; 0.5%) (Figure 1).
During 1999–2015, incidence rates of endometrioid carcinomas increased
4.5% per year, other carcinomas decreased 4.5% per year, carcinosarcomas
increased 1.9% per year, and sarcoma incidence remained stable
(Supplementary Figure, https://stacks.cdc.gov/view/cdc/60809).
In 2016, 10,733 uterine cancer deaths, corresponding to five deaths
per 100,000 women, were reported in the United States (Table). Uterine
cancer death rates among black women (nine deaths per 100,000) were
higher than those among white (five), AI/AN (four), API (four), and
Hispanic (four) women. During 1999–2016, uterine cancer death rates
increased 21%, approximately 1.1% per year on average, with larger
increases among API (52%; AAPC = 2.5%), Hispanic (33%; 1.7%), and black
(29%; 1.5%) women, than among white women (18%; 1.0%); rates were stable
among AI/AN women (Figure 2).
This report indicates that the rate of new uterine cancer cases
increased during 1999–2015, with larger increases observed among black,
AI/AN, API, and Hispanic women than among white women. This contrasts
with the recent decreases in incidence rates that have been observed for
many cancer types, such as lung and colorectal cancers (1). One
contributing factor to increasing uterine cancer incidence could be
excess body weight; women who are overweight (body mass index
[BMI] = 25.0–29.9 kg/m2) or have obesity (BMI ≥30 kg/m2) are approximately two to four times as likely to develop endometrial cancer as are women with healthy weight (4).
During 2013–2016, approximately 40% of women in the United States had
obesity, including 56% of black women and 49% of Hispanic women.*** The
U.S. Preventive Services Task Force recommends that clinicians offer or
refer adults with obesity to intensive, multicomponent behavioral
interventions.††† Community-based strategies to promote
healthy body weight include helping persons meet dietary and physical
activity guidelines by supporting healthy eating and active living in
such settings as communities, worksites, schools, and early care and
education facilities (4). Other factors such as insufficient
physical activity, increasing prevalence of diabetes, and decreasing use
of estrogen plus progestin menopausal hormone therapy might also
contribute to increases in endometrial cancer incidence (5).
This report also found that uterine cancer death rates were higher in
2016 than in 1999 and that black women were approximately twice as
likely to die from uterine cancer as were women in other racial/ethnic
groups. As with other cancers, the odds of surviving uterine cancer are
much higher when it is detected at an early stage, when treatment is
more effective (5). The 5-year relative survival estimate for
localized uterine cancer is 80%–90% compared with <30% for distant
uterine cancer (5). This report found that black women were more
likely to receive a diagnosis at distant stage and with more aggressive
histologic types than were other women, which might in part account for
the higher death rate among black women.
Although population-based screening tests are recommended for several
cancers, including breast, cervical, colorectal, and lung cancers, at
present, population-based screening tests are not recommended for
uterine cancer (6). An important early symptom of uterine cancer
is abnormal vaginal bleeding, including bleeding between periods or
after sex or any unexpected bleeding after menopause (i.e., any bleeding
except intermittent bleeding within 1 year after cessation of menses or
cyclic bleeding associated with use of cyclic postmenopausal hormone
therapy) (3). Approximately 90% of women with uterine cancer report abnormal vaginal bleeding (6).
A lower percentage of women with uterine sarcomas have abnormal vaginal
bleeding (approximately 56%) or nonspecific symptoms, such as pelvic
pain (22%); consequently, a higher percentage of sarcomas are not
detected until the cancer has already spread (7). Uterine cancer
outcomes could be improved by increasing awareness among women that
abnormal vaginal bleeding should be evaluated promptly by a health care
provider. It is also important for health care providers to perform
timely evaluation and necessary follow-up of women’s concerns and
symptoms (8). Transvaginal ultrasonography or endometrial tissue
sampling are appropriate for initial evaluation of postmenopausal
bleeding; further evaluation could include hysteroscopy combined with
endometrial sampling (8). To help women make informed choices,
health care providers can educate women about different procedural
options (including surgical choices); discuss the benefits and risks of
each procedure; and discuss the risk for cancer (9). CDC’s Inside
Knowledge campaign attempts to raise awareness among women and health
care providers about uterine cancer and other gynecologic cancers.
Inside Knowledge uses a multimedia approach to ensure campaign messages
reach the broadest audience possible.
The findings in this report are subject to at least five limitations.
First, reporting of race and ethnicity uses data from medical records
and death certificates, which might be inaccurate in some cases,
especially among AI/AN; ongoing procedures are used to ensure that this
information is as accurate as possible.§§§ Second, improved
pathologic classification of tumors over time might influence rates and
trends. Third, broad groups were used for histologic type, which might
mask varying levels of tumor behavior. Fourth, in clinical practice,
uterine cancers are commonly staged on the basis of histologic type
using the International Federation of Gynecology and Obstetrics system (6);
however, because this information is not routinely collected in cancer
registries, this report used SEER Summary Stage to stage cancers.
Finally, rate denominators were not adjusted for hysterectomy prevalence
and might include women who did not have an intact uterus and were not
at risk for uterine cancer, thus underestimating the actual rate among
women at risk, particularly black women, who have higher rates of
Multifactorial efforts at individual, community, clinical, and
systems levels to help women achieve and maintain a healthy weight and
obtain sufficient physical activity might reduce the risk for developing
uterine cancer. Promoting awareness among women and health care
providers of the need for timely evaluation of abnormal vaginal bleeding
can increase the chance that uterine cancer is detected early and