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Articles

Maternal Mortality resources: Amniotic Embolism

Genitourinary syndrome of menopause (GSM) is a relatively new term that describes the constellation of lower urogenital tract signs and symptoms associated with a low-estrogen state.

Prior nomenclature such as vulvovaginal atrophy and atrophic vaginitis failed to encompass the frequent urinary symptoms associated with menopause. GSM, which arose from a 2013 terminology consensus conference by the International Society for the Study of Women’s Sexual Health (ISSWSH) and North American Menopause Society (NAMS), is seen as a more generalizable and inclusive term with fewer negative connotations that should replace older jargon. 

GSM describes the genital, sexual and urinary changes in the lower genital tract associated with menopause. It is a chronic disorder that is unlikely to improve over time without treatment. The estrogen receptors present throughout the lower genitourinary tract respond to the decrease in circulatory estrogen after menopause with thinning of the vaginal and uro-epithelium, an increase in vaginal pH, decreases in collagen and tissue elasticity and fewer blood vessels. Physiologically, this manifests with symptoms of vaginal dryness, vaginal irritation, vaginal itching and may affect sexual function due to dyspareunia and diminished lubrication (Table 1). It is important to note that GSM also includes urologic signs and symptoms. Postmenopausal patients are more prone to recurrent urinary tract infections (UTIs), dysuria, urinary frequency and urgency.

GSM can be clinically detected in up to 90% of postmenopausal women undergoing evaluation. However, only about one-third of menopausal women report vulvovaginal symptoms when surveyed.

According to the 2010 United States census, there are approximately 50 million women over age 51, the average age of menopause.

That means approximately 17 million women experience GSM symptoms, a number that is likely increasing due to population demographics. Studies have shown that many of these women rate their symptoms as either moderate or severe. Affected women perceive declines in quality of life similar to those of patients with chronic conditions such as arthritis, chronic obstructive pulmonary disease (COPD) and irritable bowel syndrome.

GMS symptoms also negatively impact sexual satisfaction in over half of patients and strain personal relationships.

Despite the prevalence of GSM, the condition continues to be under-recognized and undertreated due to a combination of patient and provider factors. Only about one-quarter of women ever discuss their symptoms with a provider. Frequently, the burden falls on the patient to initiate the conversation.

The most common barrier to patients discussing GSM is a belief that their symptoms should just be accepted as a natural part of aging and menopause.

Other women fail to even link their symptoms with menopause.

This demonstrates a large gap in patient knowledge and an opportunity to educate patients on GSM as a medical condition. Providers need to take the initiative in screening and patient education. However, studies have shown that providers are doing a poor job at this. One study found that only 13% of providers queried their patients for GSM symptoms.

Even after diagnosis, the majority of women with GSM go untreated despite studies demonstrating a negative impact on quality of life. Hesitation to prescribe treatment by providers as well as patient-perceived concerns over safety profiles limit use of topical vaginal therapies.

The primary goal of GSM treatment is symptom relief. Options include lifestyle changes and non-hormonal and hormonal treatments. Hormonal therapies include both topical and systemic approaches. Vaginal lasers marketed for GSM have also recently arrived on the market. The theory behind laser therapy is that collagen growth is stimulated, thereby strengthening the vagina.  However, medical evidence from controlled, randomized clinical trials (RCTs) on which to base a recommendation is lacking at this time.

Tobacco abuse has been associated with increased atrophic vaginal changes as well as menopause at a younger age.

Tobacco cessation should be encouraged. Some providers recommend regular sexual intercourse, including the Society of Obstetricians and Gynaecologists of Canada.

While more sexual activity is associated with fewer atrophic changes and GSM,

it is unclear whether this finding reflects the fact that intercourse improves symptoms, or rather, that patients with fewer symptoms and less dyspareunia are more likely to engage in intercourse. The latter may well be the more likely explanation. General vulvar hygiene should be maintained with the goal of keeping the area dry and free of irritants. Cotton underwear is preferable, as well as avoidance of fragrance-containing products.

Non-hormonal therapies for GSM include vaginal moisturizers and lubricants. Vaginal moisturizers function to replace natural vaginal secretions while vaginal lubricants reduce friction during intercourse. Moisturizers commonly contain molecules that are capable of retaining large amounts of water and releasing them slowly. Examples include hyaluronic acid and polycarbophil gel. Some moisturizers have a low pH to help acidify the vaginal environment back to premenopausal physiologic levels; however, products with a pH of less than three should be avoided. Lubricants are also typically water-based but contain additional oil, glycerin, or silicone. The osmolality of the lubricant should also be taken into account. Certain brands are markedly hyperosmolar, such as Astroglide, KY Jelly, and Replens. Although these agents are often effective, their high osmolality can theoretically dehydrate the adjacent vaginal epithelium and cause irritation.

Vaginal moisturizers and lubricants provide temporary relief and may be sufficient for patients with only mild symptoms. Other non-hormonal options such as black cohosh or soy have not been shown to improve GSM.

These are not recommended for treatment. 

The gold standard pharmacologic treatment for GSM is still vaginal estrogen, especially for patients who are not suffering from systemic symptoms of menopause. Low-dose vaginal estrogen is effective and safe (Table 2).

Vaginal formulations act locally to target GSM symptoms, and result in minimal, transient elevations of circulating estradiol. Oral estrogen preparations should be reserved for primary treatment of vasomotor and other systemic menopausal symptoms. Patients who are on systemic hormonal therapy (HT) may still have GSM symptoms and therefore may get additional benefit from topical estrogen if they do not note sufficient improvement after a few months of systemic dosing. Vaginal estrogen, supplied as either estradiol or conjugated equine estrogen, comes in a variety of low-dose formulations including creams, rings and tablets. The different formulations are all considered equally effective. A new vaginal estrogen in the form of an estradiol soft gel is currently in phase III trials, formulated to not require an applicator for insertion and to dissolve faster, with less vaginal discharge than other preparations.

Ultimately, the specific vaginal estrogen formulation should be personalized for individual patients according to cost, convenience and preference. Patients are typically instructed on daily use during initiation, then to decrease frequency to twice weekly. Cessation of treatment is expected to lead to a return of symptoms. Compounded estrogen products are not recommended for use due to variability in production with inconsistent strengths, no data on individual pharmacokinetics of a vaginally administered dose, and lack of safety data. 

Various studies have demonstrated the safety of vaginal estrogen. Women using low-dose vaginal estrogen tablets and rings have a very small increase in serum estradiol levels that remains well within the normal postmenopausal range.

Data from the Women’s Health Initiative have also demonstrated the relative safety of vaginal estrogen preparations. Over 45,000 women using either vaginal estrogen cream or tablet were followed. On average, women used vaginal estrogen for a median duration of two years for a median follow-up of seven years.

Vaginal estrogen users had similar rates of endometrial cancer, invasive breast cancer and pulmonary embolism/deep vein thrombosis as non-users. In fact, risks of coronary heart disease, fracture and all-cause mortality were lower in vaginal estrogen users.

Multiple studies have investigated the endometrial safety of vaginal estrogen, including two randomized controlled trials (RCTs) that documented no difference in endometrial hyperplasia or cancer with endometrial biopsy samples after 12 months of vaginal estrogen exposure.

Additional progestin for endometrial protection, therefore, is not thought to be needed during low-dose vaginal estrogen use. Contraindications to vaginal estrogen use include unexplained uterine bleeding, endometrial hyperplasia or cancer and use of aromatase inhibitors (AIs). 

The packaging for vaginal estrogen includes the same information as for systemic estrogen. The package insert includes a “black box” warning, which states an increased risk of: “endometrial cancer, cardiovascular disorders, breast cancer and probable dementia.” This warning, which understandably frightens patients, is applied by the US Food and Drug Administration (FDA) to any estrogen-containing pharmaceutical. Yet all of the data supporting this warning derives from clinical trials involving systemic hormone exposure at much higher doses. With the current abundant data that exist demonstrating the differences in safety profiles and serum estrogen levels between vaginal estrogen and oral estrogen, NAMS and other organizations have teamed up to recommend to the FDA that the boxed warning be removed from topical estrogen preparations.

Alternatives to estrogen for treatment of GSM include selective estrogen receptor modulators (SERM). SERMs act to stimulate estrogen receptors in certain tissues while blocking them in others. The most well-known SERMs were designed to treat breast cancer. Specific SERMs are now on the market to treat GSM and serve as pharmacologic alternatives for women who are not candidates for estrogen use. Ospemifene has been available since 2013 and is approved for treatment of dyspareunia due to GSM as a daily oral tablet. Studies have demonstrated improvement in GSM symptoms compared to placebo.

Ospemifene acts as an agonist on vaginal epithelium while avoiding a stimulatory effect on endometrial and breast tissue. Endometrial safety, based on endometrial thickness, has been demonstrated out to one year of use.

Ospemifene has an antagonistic effect on breast tissue in ex vivo studies, however, its use and safety in patients with a history of breast cancer has yet to be studied.

Side effects of ospemifene that may limit its use include an increase in hot flashes, need for daily, systemic administration, and delayed therapeutic effect.

Many women do not see benefits until about six months after initiation. Venous thromboembolism (VTE) risk is also a concern for any SERM and the safety of ospemifene appears similar to other SERMs, with a small increase in risk that is not as much as the risk seen with estrogen. Lasofoxifene is another SERM not yet approved for use in the United States. It has been shown to help GSM symptoms while also improving bone density and decreasing breast cancer risk in a postmenopausal population.

However, lasofoxifene has also been associated with an increase in endometrial polyps, though not necessarily hyperplasia or cancer.

Lasofoxifene seems promising as a possible treatment option in patients with a history of breast cancer but as of now, it remains in phase III development. We suggest use of ospemifene for patients who fail over-the-counter treatments and who have contraindications to vaginal estrogen treatment or who strongly want to avoid estrogen therapy. Providers should be aware that ospemifene packaging contains a black box warning regarding VTE risk. 

The newest alternative to vaginal estrogen treatment is vaginal dehydroepiandrosterone (DHEA), also known as prasterone, which was approved in 2016 for dyspareunia related to GSM. Prasterone likely works by local conversion of androstenedione and testosterone into estrone and estradiol. In RCTs, prasterone has been shown to decrease dyspareunia compared to placebo in postmenopausal women.

Prasterone increases circulating DHEA, testosterone, and estrone, however, hormone levels are maintained within normal postmenopausal ranges after 12 weeks.

Studies regarding prasterone safety in patients with a history of cancer, specifically, breast cancer, have not been conducted yet. Prasterone is a vaginal insert that, unlike vaginal estrogen, requires daily administration. 

Though there have not been head-to-head trials comparing ospemifene or prasterone against vaginal estrogen, the efficacy of vaginal estrogen has been well demonstrated and its safety profile is far lengthier than that of the current alternatives. In addition, vaginal estrogen does not require daily administration unlike ospemifene or prasterone. We still recommend vaginal estrogen as a first-line option for patients who seek pharmaceutical treatment for GSM. 

) laser therapy, popularly called “vaginal rejuvenation,” has been proffered as an attractive alternative to hormonal therapy. Laser treatments use CO

wavelengths to ablate and coagulate mucosal tissue, thereby stimulating wound healing and tissue remodeling with increased collagen formation. Treatment usually consists of a series of short in-office procedures six weeks apart that can cost thousands of dollars. Early case series and other clinical studies have demonstrated improvement in GSM symptoms, however, these studies suffer from small sample sizes (few with more than 20 women), a lack of randomization, no placebo-treated control group, and short follow-up (20 weeks). One small (sample size 45) RCT comparing CO

laser with vaginal estrogen, each agent alone, both combined, with a no-treatment control group, demonstrated that in the combined treatment group, symptom improvement was greater than treatment with vaginal estrogen alone. However, laser therapy alone was associated with worse dyspareunia.

Larger studies demonstrating long-term safety and efficacy, as well as an analysis of cost-effectiveness, are needed before this modality can be recommended. Moreover, laser therapy for GSM is not FDA-approved at this time. The American College of Obstetricians and Gynecologists’ most recent position statement on laser therapy from May 2016 emphasizes the importance of accurately informing patients of a treatment’s FDA status. It advises providers to be wary regarding new trends based on “promotions or marketing.” 

A history of breast cancer complicates treatment of GSM, especially for women with hormone receptor-positive histology. GSM complaints are common in this patient population, especially among patients treated with AIs. First-line therapy should always include non-hormonal vaginal moisturizers and lubricants. If those fail, low-dose vaginal estrogen can be considered. An individualized decision should be made in conjunction with the patient’s oncologist. Few studies have demonstrated vaginal estrogen safety in breast cancer patients. One prospective cohort study followed 69 women with a history of breast cancer who used vaginal estrogen for an average of one year. The study found no increased risk of breast cancer recurrence.

However, this study was limited by its small sample size and relatively brief follow-up. Larger and longer-term studies are needed to provide more confidence that low-dose vaginal estrogen will not affect breast cancer recurrence rates. If vaginal estrogen is to be used for compassionate reasons, preparations that result in the lowest systemic estradiol concentrations are recommended and treatment should be for the shortest duration possible. Patients using AIs may be at risk if they use vaginal estrogen. A small study demonstrated a rise in serum estradiol levels in six women using Vagifem while taking AIs, thereby eliminating the goal of maximally suppressing estrogen levels.

Clearly, this is a setting in which shared decision-making with an informed patient is of paramount importance.

GSM continues to be underreported and undertreated, despite the large number of postmenopausal women suffering from this chronic condition. Patients may suffer silently, perceiving their symptoms to be a natural aspect of aging, or may be hesitant to bring up this sensitive issue with their providers. Providers have much room to improve on screening patients for GSM. 

Treatment should always start non-pharmacologically with topical moisturizers and lubricants. For those who require prescription therapy, we recommend vaginal estrogen in cream, ring or tablet form. Multiple formulations may need to be trialed before finding a price point acceptable to the patient as insurance coverage varies greatly. Systemic estrogen therapy should be reserved for primary treatment of other, body-wide menopausal symptoms. Patients taking systemic estrogen may still suffer from GSM and could benefit from additional vaginal estrogen therapy. 

Ospemifene is an alternative prescription option for GSM that is approved by the FDA and may be a good option for patients with a history of breast cancer or who want to avoid estrogen, however, it may increase hot flashes and requires daily oral dosing. The need for more long-term data on prasterone prohibits us from recommending it as a treatment option at this time. Laser therapies also require larger studies on long-term efficacy, safety and cost-effectiveness. 

NEXT: Download the patient education handout

A downloadable handout for your patient to help educate her about GSM. 

The authors report no potential conflicts of interest with regard to this article.

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Despite the prevalence of GSM, the condition continues to be under-recognized and undertreated due to a combination of patient and provider factors. Providers need to take the initiative in screening and patient education.

Genitourinary syndrome of menopause: Underdiagnosed and undertreated

Breastfeeding is associated with improved health outcomes for mothers. The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (ACOG) recommend exclusive breastfeeding for the first six months of life with introduction of complementary foods at six months and continued breastfeeding through the infant’s first year of life and beyond as mutually desired.

Current breastfeeding rates are below the Healthy People 2020 (HP2020) target established by the United States Department of Health and Human Services (Table 1).

In addition, there are substantial racial and ethnic disparities in breastfeeding rates in the United States. Although no ethnic group has attained all the HP2020 breastfeeding goals, non-Hispanic black and American Indian/Alaska native women have the lowest rates.

This article reviews recommendations for breastfeeding and current breastfeeding rates; positive maternal health outcomes associated with breastfeeding; and evidence-based practices that enable women to successfully achieve their breastfeeding goals. 

Pregnancy is associated with metabolic changes such as increased insulin resistance, hyperlipidemia, and visceral fat accumulation. Persistence of the metabolic changes that occur during pregnancy has been theorized to increase a woman’s lifetime metabolic disease risk.

Lactation may play a role in reversing these changes more rapidly. Also, adverse pregnancy outcomes such as preeclampsia, gestational diabetes and preterm delivery are associated with a higher maternal incidence of cardiometabolic diseases later in life. Breastfeeding is associated with risk reduction in these cardiometabolic diseases.

For example, up to 50% of women with gestational diabetes develop Type 2 diabetes mellitus (T2D) within five years postpartum, and greater than one to three months of lactation is associated with approximately 80% reduction in the cumulative incidence of T2D at five years postpartum.

The association between breastfeeding and women’s health has been studied extensively (Table 2).

A longer duration of breastfeeding has been associated with a risk reduction in breast cancer,

Sustained breastfeeding is associated with greater maternal benefit. In a recent cost analysis, Bartick et al. modeled maternal and child health outcomes using current national rates in comparison to optimal breastfeeding (defined as 90% of mothers exclusively breastfeeding each child for six months and continuing to breastfeed for 12 months). Across the lifetime of a cohort of women born in a single year, they found current suboptimal breastfeeding rates were associated with an excess of 2,619 premature maternal deaths (95% CI 1,978 to 3,259).

Studies reveal an association between breastfeeding and improved maternal health; however, this association may not be causal. First, most studies are observational because it is unethical to randomize women to breastfeed or formula-feed. Randomized trials of breastfeeding have focused on types of support. As an example, the PROBIT study conducted in Belarus in the 1990s consisted of 17,046 mother-infant pairs. All mothers initiated breastfeeding and there was a small difference (8%-15%) in absolute breastfeeding rates between the intervention and control groups over the first postpartum year, limiting the ability to detect differences in health outcomes.

Secondly, outcomes may be confounded by differences in health behaviors: mothers who breastfeed are more likely to be white, married, better educated, wealthier, leaner, and less likely to use tobacco or recreational drugs when compared with women who do not breastfeed.

Finally, baseline metabolic risk factors such as obesity and insulin resistance may negatively impact lactogenesis and breastfeeding duration.

Clinical practices that support breastfeeding 

Despite the maternal health benefits associated with breastfeeding, anticipatory guidance from ob/gyns is inconsistent: In one study, breastfeeding was discussed at 29% of initial prenatal visits and conversations lasted 39 seconds on average.

The World Health Organization/ UNICEF Ten Steps to Successful Breastfeeding increases breastfeeding success (Table 3).

The 10 steps are evidence-based practices that have been demonstrated to increase breastfeeding initiation and duration. Other strategies that improve breastfeeding rates include access to breast pumps, group prenatal classes, peer counseling, and clinic appointments for breastfeeding problems.

Providers are encouraged to initiate education on the benefits and management of breastfeeding from the first prenatal appointment and continue throughout pregnancy. Prescriptions for breast pumps and training in usage can be provided to women planning to return to work. Maternal risk factors for breastfeeding difficulties such as obesity, variations in breast anatomy and primiparity should we reviewed and anticipatory guidance provided.

One common cause of iatrogenic early weaning is inaccurate information on medication use. Health care providers often provide inaccurate information about medication use during breastfeeding.

Most medications are compatible with breastfeeding, but inappropriate information may lead to unnecessary cessation of lactation.

Reliable up-to-date resources on medication in lactation include Lactmed (

https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm

In the intrapartum period, providers should emphasize the importance of skin-to-skin contact in the immediate postpartum period and breastfeeding initiation within the first hour after birth. Postpartum, referral to sources of lactation support such as La Leche League, peer counselors, and hospital support groups may enable women to achieve their breastfeeding goals. Breast-feeding problems should be addressed by assessment of the mother-infant dyad in conjunction with an International Board-Certified Lactation Consultant.

Ob/gyns can play an important role by: (1) Developing knowledge and skills in basic lactation management; (2) Encouraging and supporting women to initiate and sustain breastfeeding; (3) Being a resource for mothers experiencing difficulties with breastfeeding; (4) Promoting the integration of the Ten Steps into maternity care; and (5) Advocating for policies that help women achieve their breastfeeding goals, such as paid maternity leave and break time for milk expression.

Breastfeeding is associated with substantial differences in health outcomes for mothers. Lactation is a core component of reproductive physiology, and thus in the domain of women’s health providers.

Enabling women to meet their breastfeeding goals is therefore an integral part of women’s health care. 

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This article reviews recommendations for breastfeeding and current breastfeeding rates; positive maternal health outcomes associated with breastfeeding; and evidence-based practices that enable women to successfully achieve their breastfeeding goals.

Long-term maternal benefits of breastfeeding

A 19-year-old Florida woman brought a malpractice action following the delivery of her child by an obstetrician employed by a federally funded medical clinic. She claimed the obstetrician was negligent for failing to perform an emergency cesarean and continuing use of oxytocin despite ominous signs of fetal compromise. As a result, the child suffered a severe brain injury requiring 24-hour professional care for the rest of his life.

The obstetrician argued that the patient refused cesarean delivery multiple times, against the obstetrician’s medical advice, prior to the vaginal delivery. He noted the refusals in the medical records. He claimed he did not fall below the standard of care in administering oxytocin or using a vacuum for delivery because the patient refused the recommended cesarean delivery.

The jury found in favorof the child, the patient, and the husband, including $20,965,144 for the child’s future economic damages and  $7.625 million for his non-economic damages as well as $3.3 million for the patient and $1 million to the father.


		Oxytocin is one of the most frequently used drugs during labor but it can also become a major issue in a malpractice case filed after a labor and delivery if there is an adverse outcome. If the drug is used during labor, all policies and protocols in effect at the time will be requested during discovery and will be compared to how the patient’s oxytocin dose was managed. Any deviation from the protocol will be pointed out as care falling below the standard, whether or not it had anything to do with the alleged injury. It is imperative that everyone administering oxytocin during labor is aware of what the protocol requires and documents any reason or thought process for deviating from that protocol.

Did aggressive use of oxytocin cause uterine rupture?


	A Kansas woman presented to a hospital in labor at term. The on-call obstetrician ordered oxytocin augmentation. According to protocol, dosage of the drug was to be increased by 2 MU up to 30 MU or until adequate contraction pattern was observed. Over the next few hours, the nurses increased the infusion several times. When the patient began to push, a bloody discharge from the vagina was noted and the fetal heart rate (FHR) was temporarily lost. When the FHR was found, it was down to 50 beats per minute. After a few attempts to deliver the infant by vacuum and forceps, an emergency cesarean was performed. The patient had a ruptured uterus and the infant suffered permanent brain injury.

The patient sued those involved with the delivery, alleging the health care providers fell below the standard of care by negligently increasing and maintaining the oxytocin at unsafe levels, causing the uterine rupture. The result was a lack of oxygen to the fetus, which caused the subsequent brain injury. The patient’s expert obstetrician testified that the patient’s uterine contractions were adequate when the oxytocin dose reached 14 MU/minute, but the dose continued to be increased.

 The parties reached a$3.5 million settlement.

 - This will be my final column for Contemporary OB/GYN. I have had the privilege of writing for this magazine for many years and thank the editorial leadership and staff for that opportunity. And thanks to you, the readers, for all your comments and for making the Legally Speaking column a success. – Dawn Collins, JD

Hysterectomy, bowel perforation, multiple complications


	A Mississippi woman underwent a hysterectomy in 2011, performed by her gynecologist. Two days later, she returned to the emergency room with complaints of pain. The following day, she was seen by her gynecologist and admitted to the hospital. A general surgery consult was ordered. Exploratory laparotomy performed the next day revealed an abscess and a 1-cm bowel perforation, which was repaired. Despite the repair, the patient endured a rigorous course of recovery. She developed pneumonia, respiratory failure, underwent multiple surgeries, and had recurrent abscesses and fistulas.


	The woman sued the gynecologist, alleging he was negligent in perforating her bowel and failing to timely recognize the injury. Her expert opined that such an injury can sometimes be a surgical complication, but it was not in this case as it was alleged the gynecologist was rushed in performing this procedure because he had a patient at another hospital waiting for a cesarean delivery.
	The gynecologist denied all liability and argued the perforation happened days after the operation within an abscess. He claimed it would have been obvious to him if it occurred during surgery.
	
	

 The jury deliberated for two and a half hours at the conclusion of an  eight day trial and returned a defense verdict. 

Severe hemorrhage, life-threatening complications


	In 2013, a 46-year-old North Carolina woman was suffering with a history of increasingly frequent and painful menstrual periods. Her gynecologist was unable to prescribe oral contraceptives due to the patient’s hypertension and recommended a hysteroscopy with resection of a submucosal fibroid, a dilation and curettage, and endometrial ablation. During the procedure, the gynecologist encountered the 2-cm fibroid and attempted to morcellate it from the anterior wall down to a normal-appearing uterine cavity. Although the estimated blood loss was noted to be less than 100 mL the patient began hemorrhaging immediately. The nurses informed the gynecologist multiple times over the course of seven hours that the patient was experiencing severe bleeding. When the gynecologist finally examined the patient, he found that she was in hemorrhagic shock and advised her that a hysterectomy was necessary. During that operation, the woman’s bladder was lacerated twice. After hours of attempting to repair the damage, a urologist was called in to assist. Postoperatively the patient suffered a stroke, respiratory failure, kidney failure, permanent sterility, and significant bladder complications.

The woman sued the gynecologist alleging all the complications she suffered were the result of the gynecologist’s actions.
	 
	

 The case settled for a confidential amount at mediation. 

Alleged catheter tip found in bladder years after hysterectomy


	An Alabama woman underwent a hysterectomy in 2009. As part of the procedure, a Foley catheter was inserted in the bladder and the balloon was inflated. The catheter was removed a week later when the patient when to see the gynecologist. At that time, she complained of pain and the gynecologist was called back in to speak with her. Subsequently, she suffered persistent pain and infections related to her bladder. Three months later, the woman’s primary care physician referred her to a urologist, who ordered a computed tomography scan of the bladder. The report noted a “linear band of hyper dense material . . . which could represent some minimal areas of hemorrhage or debris” but no further investigation was done. Over two years later, the patient continued to experience bladder problems that no healthcare providers could treat definitively. In 2012, a surgeon performed bladder surgery and removed an object which he believed to be a catheter tip. The subsequent pathology report on the object identified it as a calcified catheter tip.
	The patient sued her healthcare providers, including the gynecologist, urologist, primary care physician, radiologist, and hospital. She criticized the gynecologist for not having removed the catheter tip, and the others for not having discovered its continuing presence in a timelier fashion. According to the gynecologist, he tested the balloon and examined the tip of the catheter after it was removed. Both were intact. The patient later questioned whether he actually checked the integrity of the catheter. The notes in the medical records did not indicate that he had performed this check when the catheter was removed.
	The defendants responded with a denial of any breach of the standard of care. The gynecologist could not remember who inserted the catheter or who took it out and further expressed uncertainty that any catheter had been removed from the patient in his office. Finally, the gynecologist and the urologist questioned whether the item removed from the patient’s bladder was a catheter tip, although the pathology report stated the contrary.

 The first trial began in July of 2017 but ended in a mistrial after the jury heard inadmissible evidence about the defendants’ liability insurance. The second trial lasted eight days and the jury found in favor of all the defendants.

"  target="_blank">Death due to cardiomyopathy during pregnancy


	A 30-year-old California woman experienced shortness of breath and chest discomfort during her pregnancy while lying down. To alleviate the shortness of breath, she propped herself up with pillows. The woman informed her obstetrician of her symptoms and was told they were common in pregnancy. That conversation was not recorded in the patient’s medical record and no further investigation was done. A month later, the woman’s husband found her unresponsive at 24 weeks’ gestation and called an ambulance. She was taken to the hospital and immediately delivered but pronounced dead after delivery. The infant died three days later due to extreme prematurity. The woman’s autopsy showed she died due to an undiagnosed cardiomyopathy and suffered a sudden cardiac arrhythmia.

A lawsuit was filed against the obstetrician, alleging that she should have investigated the patient’s symptoms further and that her dismissal of the patient’s complaints deprived her of a proper diagnosis and treatment that could have saved her life. The lawsuit claimed an echocardiogram would have revealed the patient’s condition and she could have been treated.

The obstetrician asserted that her evaluation and determination based on the patient’s symptoms were reasonable and within the standard of care. She also maintained that because the symptoms were determined to be a result of the pregnancy, it was not necessary to note that in the chart. She also argued that it would have taken close to a month to determine the diagnosis and any treatment would have only minimized the probability of a cardiac arrhythmia, not prevented it.
	
	

 The jury deliberated for almost two and a half hours at the conclusion of an 11-day trial and returned a defense verdict.


	This tragic case presentation underscores the need to educate all clinicians about the increasing prevalence of cardiac complications during pregnancy. Cardiac disease including cardiomyopathy is the leading etiology of maternal death as detailed in our opening January editorial - http://bit.ly/CVmorbidity. While the physiologic changes of pregnancy can lead to maternal complaints of breathlessness and fatigue, pregnancy can unmask congenital or acquired cardiac disease. Cardiac conditions that may precede pregnancy or be pregnancy-associated can be life-threatening including: cardiomyopathy, valvular disease or arrhythmias.  Attributing these symptoms to “just pregnancy” is a diagnosis of exclusion. Any patient with persistent signs and symptoms of dyspnea requires thorough evaluation with EKG and echocardiogram. 

 is Director of Ultrasound, Fetal Echocardiography and Perinatal Research at Valley Hospital in Ridgewood, New Jersey, and Clinical Professor of Obstetrics and Gynecology at NYU School of Medicine, New York. She works actively with ACOG and the American Heart Association (AHA) on issues of maternal cardiac arrest and mortality. Dr. Zelop is the Series Editor of the 

Oxytocin is one of the most frequently used drugs during labor but it can also become a major issue in a malpractice case filed after a labor and delivery if there is an adverse outcome. PLUS: Carolyn Zelop, MD, provides commentary on a lawsuit involving a patient death during pregnancy due to cardiomyopathy.

Oxytocin suspect in cases with poor outcomes

The concept of an enhanced recovery program following elective surgery was developed more than 15 years ago.

  It refers to multimodal care pathways designed to accelerate patient recovery by reducing the surgical stress response and supporting the patient’s physiologic function. These procedures and anesthesia-specific pathways form an integrated continuum, as the patient moves from home through the preoperative, intraoperative, and postoperative phases of surgery and returns home again.

A key component of enhanced recovery after surgery (ERAS) is patient and family engagement, which helps patients better prepare for surgery, hospitalization and discharge. The aim of enhanced recovery is to optimize multiple aspects of patient care, improve recovery, and facilitate earlier discharge with increasing patient satisfaction and quality of care. One of the central elements of our ERAS protocol is the application of multimodal pain interventions to reduce the reliance on opioid-based medications. 

Much of the work establishing the beneï¬ts of enhanced recovery has been conducted on patients undergoing colorectal surgery, but the same concepts have since been used in gynecology, urology and orthopedics.

Despite demonstrated success in Europe, the transition to evidence-based enhanced recovery has been slow in surgical and anesthesia practice in the United States, partly because of a lack of awareness, and also due to reluctance of some healthcare team members to embrace change.

  Until recently, there has been little interest in enhanced recovery after cesarean delivery. However, since 2012, multiple obstetrical units in the United Kingdom have introduced enhanced recovery programs in obstetrics and have demonstrated improved quality of care and significant savings with superior patient satisfaction.

The Saint Peter’s/Axia experience with ERAS

The relative lack of experience with enhanced recovery after obstetrical surgery in the United States provided us with a unique opportunity to pioneer this process at Saint Peter’s University Hospital and within Axia Women’s Health. Axia Women’s Health is comprised of more than 250 physicians at over 100 patient care centers located in New Jersey and Pennsylvania. Axia provides patients a full spectrum of care in obstetrics, gynecology, fertility, maternal fetal medicine and women’s imaging centers.  We launched our ERAS obstetrical pathway in 2016 for low-risk patients with the diagnosis of repeat cesarean delivery. The four tenets of our program are: 

Improved preoperative assessment, planning and preparation before admission;

A structured approach to immediate perioperative and postoperative management, including pain relief; 

To improve perioperative assessment, planning and preparation for admission, our team partnered with SeamlessMD, a leading provider of clinical intelligence platforms, to develop a smartphone application to engage and empower our patients. Our patient application has a wide range of capabilities, including the ability to provide preoperative education, timely reminders, and remote monitoring. Our analytics dashboard collects patient-generated data from across the platform. For instance, patients are prompted to report their mood, appearance of their incision, success of breastfeeding, extent of mobilization, pain scores and narcotic use for 2 weeks postoperatively. Our dashboard is monitored and becomes actionable, preventing readmissions and complications while empowering patients. 

All patients receive a detailed explanation about ERAS from their obstetrician and download their application during their 36-week prenatal visit. We provide “bite-size” information at the right time using appropriate language delivered by interactive multimedia. We push notifications to patients daily about their surgery, and pre- and postoperative care. Involving patients and their families is fundamental to ERAS and empowers patients to take a significant role in and ownership over decisions regarding their care. The information significantly reduces their fear and challenges preconceived ideas about the operation, pain, recovery and length of stay.

Our second aim was to reduce the physical stress of surgery, so all patients receive a preoperative complex carbohydrate drink and 40 mg of famotidine the evening before their procedure. On the morning of surgery, patients have a second clear complex carbohydrate drink 2 to 3 hours before their scheduled cesarean delivery. This physiologically improves cortisol, insulin and glucose levels and thus recovery. Intraoperatively, we warm patients by placing a whole body warmer on the operating table to prevent hypothermia, and by warming preoperative intravenous (IV) fluids, thus controlling perioperative temperature management. We allow skin to skin in the operating room for early breastfeeding and continue this in the recovery room.

We also reduce the stress of surgery by giving all patients triple antiemetic prophylaxis with 4 mg IV ondansetron, 10 mg dexamethasone, and 10 mg metoclopramide intraoperatively. We also have a standard intraoperative protocol with a subarachnoid block with 0.75% bupivacaine and fentanyl. Additionally, 0.15 mg intrathecal morphine is added to the subarachnoid medications for postoperative pain control.

For our pain management protocol, we give two very effective non-opioid medications in alternating doses around the clock. A patient receives pain medication every 3 hours for the first 24 hours automatically. We give the nonsteroidal ant-inflammatory drugs ketorolac 30 mg IV and 1000 mg acetaminophen IV in alternating sequences. These medications are not on-demand, thus eliminating the up and down rollercoaster effect; patients are no longer over-sedated nor behind on pain control. Starting 24 hours after surgery, patients are switched to 600 mg of ibuprofen and 650 mg of acetaminophen by mouth. These are also distributed in alternating sequence and not on demand. Starting on postoperative Day 2 and only for breakthrough pain, 2 mg of hydromorphone  by mouth is available on an as-needed basis. 

Lastly, we improve mobilization. There is evidence to suggest that mobilization reduces incidence of venous thromboembolism and pulmonary complications.

After transfer to the post-partum floor when full motor function is confirmed, patients are helped to a chair and subsequently walk a few steps with assistance. We remove Foley catheters six hours after surgery and remove IV catheters on Day 0. By removing the Foley catheters on postoperative Day 0, patients are getting up to use the bathroom and on postoperative Day 1 they are eating all meals out of bed and walking the length of the hallways.

After launching our ERAS program in the fall of 2016, we enrolled over 100 patients in the first year. Our length of stay was reduced from 3.7 days to 2.45 days. As a result of implementing our protocol, our patients have been able to reduce narcotic use five- to six-fold. Most patients do not receive narcotic pain relief in the hospital or after discharge. Other benefits and advantages of our ERAS include minimizing disruption of eating and drinking before surgery and post-delivery, as well as increasing early skin-to-skin contact with their newborns. Patients are ambulating earlier and have their indwelling catheters removed on postoperative Day 0. We have had a 68% response rate to our patient engagement application and an increase in patient satisfaction. Patients appear to be comforted by the ability of providers to monitor their progress through our dashboard after discharge. Axia Women’s Health providers can log in to the web-based dash board from their office and follow all postoperative patients. Providers can follow patient’s pain and mood scores that they have entered on their smart phone application. We follow their breastfeeding success and patients can even send descriptions and pictures of their incision. Axia Women’s Health developed our application with SeamlessMD as a strategy to engage patients in the ERAS protocol. Developing similar communication approaches are likely important to the success of any ERAS protocol.

At this ob/gyn’s institution, a program that helped patients better prepare for surgery, hospitalization, and discharge resulted in shorter lengths of stay and less use of narcotics.

Kehlet H. Care after colonic operation: is it evidence-based? Results from multinational survey in Europe and the United States. J Am Coll Surg 2006;202:45-54.

An ob/gyn shares her experience with implementing enhanced recovery after surgery (ERAS) and its effect on patient care at her institution

Vol. 64 No. 07

Maternal Mortality resources: Amniotic Embolism

Genitourinary syndrome of menopause: Underdiagnosed and undertreated

Long-term maternal benefits of breastfeeding

Oxytocin suspect in cases with poor outcomes

ERAS: Improved outcomes post-cesarean

Fertility banking – how secure is it?

Managing obstetric emergencies: Anaphylactoid syndrome of pregnancy (aka AFE)