Though theoretical, the threat of aerosolized viral particles places health care providers at risk. Certain safety measures can be taken. View the full, peer-reviewed article, and more, in this month's edition of Contemporary OB/GYN.

July 2020 | Vol 65 No 07

Judith M. Orvos, ELS, is a a BELS-certified medical writer and editor and an editorial consultant for Contemporary OB/GYN.

, the study focused on trends in Los Angeles and Indianapolis and looked at not only domestic violence but crimes such as burglary, assault, and vehicle theft.

For the research, the authors analyzed daily counts of calls for service in the two cities beginning on January 2, 2020 and ending on April 21 for Los Angeles and April 18 for Indianapolis. Those time periods were defined as after shelter-in-place orders were given. Excluded from the analysis were time periods between school closings and shelter-in-place orders.

The objective was to compare full social distancing effects (post stay-at-home orders) to a baseline with no social distancing orders yet implemented. Expected police call rate change was computed by multiplying the estimated coefficient of residential mobility by the average residential mobility index post-shelter-in-place minus the average pre-school closing.

Significant increases in domestic violence calls were found in both Los Angeles and Indianapolis (expected call rate increases of 13.5495 and 15.2112; 

In contrast, call rate changes for burglary in Los Angeles and Indianapolis declined by 19.2740 and 2.3061, respectively. For robbery and battery, rates declined in both in Los Angeles and stayed the same in Indianapolis.

“The marginal decline in residential burglaries, marginal increase in auto thefts, and increase in domestic violence calls points to shifts in crime patterns to which police departments will necessarily have to respond,” said the authors. 

They noted, however, that “despite domestic violence having been one of the crimes least reported to the police, with approximately half of domestic victimization being unreported, our results indicate that calls concerning domestic violence significantly increased in both Indianapolis and Los Angeles.”

Mohler G, Bertozzi AL, Carter J, Short MB, Sledge D, Tita GE, et al. Impact of social distancing during COVID-19 pandemic on crime in Los Angeles and Indianapolis. 

. 2020;68:101692. https://doi.org/10.1016/j.jcrimjus.2020.101692

Articles

A new analysis by researchers who analyze crime statistics shows that in two major metropolitan areas, domestic violence reports increased during the COVID-19 pandemic.

Domestic violence reports increase in two major cities during COVID-19

Though her face was covered with a mask, her frustration was clear. As a 38-year-old woman who had recently moved to the United States with her husband for an exciting job opportunity, she has been taking combined oral contraceptives (COCs) reliably for the past 20 years with no pregnancies. 

In Brazil, she would simply walk into her neighborhood store and buy a pack of COCs along with her shampoo. She had known for her whole life that she didn’t want children and remained highly motivated to avoid pregnancy, especially now that she is in America and had a chance to further her career beyond what she could achieve in Brazil.

I met her amid a global pandemic, as she had been granted an urgent appointment to our otherwise closed outpatient clinic due to an early undesired pregnancy. The last physician she saw would only provide her with 1 month of COCs to carry her over until she could be seen for an annual exam. 

This single pill pack ended as the COVID-19 pandemic reached our state and the stay-at-home order was initiated. She was unable to get a refill from the initial prescribing physician and, though she tried to be careful, ultimately conceived.

The current COVID-19 pandemic has amplified the existing unnecessary barriers to contraception, much to the detriment of women. My patient wasn’t alone in her interest in over-the counter (OTC) contraception. 

A survey nearly 10 years ago in the United States demonstrated that two-thirds of women were in favor of the concept and one-third would utilize it themselves.

A recent survey of over 2,000 women and 500 adolescents in the United States revealed that nearly 40% and 30% of each group would be interested in OTC progestin-only pill (POP) access.

Now is the time to give women like my patient access to hormonal contraception over the counter.

In the United States, there are an estimated 43 million women at risk of unintended pregnancy.3 Prescription-based contraceptive methods are actively used by nearly one-third of contracepting women, and four of five sexually experienced women have used an oral contraceptive (OC) pill at some point in their lifetime.

Although physicians are typically most familiar prescribing OCs, the transdermal patch, and the monthly vaginal ring, there is also a self-administered subcutaneous form (104 mg) of depot-medroxyprogesterone acetate (DMPA) that can be directly prescribed to women.5 

With the subcutaneous formulation, women can self-inject their DMPA via a small 3/8-inch needle without requiring an in-person visit for the standard 150mg intramuscular injection (Figure 1).

Barriers to accessing hormonal contraception

Unfortunately, women experienced a multitude of barriers to prescription-based contraception long before the COVID-19 pandemic. One large survey of US women currently on prescription methods including OCs, the transdermal patch, and monthly vaginal ring, revealed that one-third of them had experienced access barriers while initiating or continuing their chosen method.

Of the women who reported barriers, the vast majority (62%) were related to the physical need to see a provider in an office to obtain a prescription. Other factors such as cost (25%), pharmacy access (7%), and non-specified barriers (6%) were significantly less common.

Our specialty has successfully overcome the limitations of prescription status on access to reproductive health services, specifically in the context of oral levonorgestrel emergency contraception. Although initially prescription-only when approved by the US Food and Drug Administration in 1998, oral levonorgestrel emergency contraception (EC) was given OTC status in 2006 for women age 18 and above.

In 2013, the age restriction was removed so anyone with reproductive potential could access this form of EC.

 After transitioning to OTC status, adult use of oral levonorgestrel EC increased from 4% of women in 2002 (prior to OTC conversion) to 11% of women by 2010, amounting to a total of 5.8 million women who had ever used this product.

Since the day-to-day intricacies of women's lives vary tremendously, we need a multitude of ways that they can access their preferred contraceptive method. Some women may still prefer in-office visits, but our experience with the OTC transition of oral levonorgestrel EC showed that women need the option to buy contraceptive methods directly off the shelf.

As an intermediate step toward OTC status, some states have given pharmacists the ability to provide hormonal contraception directly to people without a prescription from a provider. Through this behind-the-counter model, the pharmacist performs a risk assessment and sometimes a blood pressure measurement prior to dispensing combined hormonal contraception (CHC) (COC), transdermal patch, monthly vaginal ring). 

The most recent tally shows that 13 states along with Washington, D.C., allow pharmacists to directly dispense some types of hormonal contraception.

 Nuances of behind-the-counter provision vary. Only nine of these states (along with Washington, D.C.,) allow the pharmacist to give the method directly to the patient without any prescriber involvement.

Four states actually require a collaborative practice agreement between pharmacists and providers, creating another possible barrier.

Though a step in the right direction, behind-the-counter hormonal contraception still has its limitations. Pharmacist reimbursement for their patient assessment and counseling has also been a logistical obstacle and potential disincentive.

These visit costs can get passed down to patients. In addition, we know that women experience pharmacist objection to dispensation of reproductive health products such as EC and this is will likely occur with other contraceptive products.

A variety of health care organizations and private companies have tried to address theseaccess barriers and created systems of online contraceptive consultation with mail-order products. Women undergo standard health screening, with variation in other requirements like recent blood pressure measurement. 

Sites also often charge women a separate consultation fee and vary in insurance acceptance. Importantly, women may find it difficult to obtain a clear estimate of insurance coverage. Some sites offer a clear low-cost cash option so women can gauge this option as a back-up if their insurance coverage is limited.

Online hormonal contraceptive access is a convenient option for many women, but there is still a large cohort for whom this is not an option. Access to online hormonal contraception changes depending on which state a woman orders her method from since legal restrictions vary widely. 

States with restricted online contraceptive access are typically those with restrictive laws regarding in-person contraceptive provision or insurance coverage, so online access cannot totally overcome geographic disparities.

Though most women have Internet access to visit these websites, translating the online encounters into actual in-hand contraception can pose additional challenges. Requiring an electronic method of payment may be a barrier to some people. Women and adolescents can have challenges obtaining electronic methods such as credit cards for a wide range of reasons. 

Privacy is still a risk with obtaining online contraception, whether through the electronic record of the transaction or the risk of a package being opened or intercepted at home. Those facing reproductive coercion or domestic violence are particularly at risk and lose the opportunity to have their method in hand right away so they can take necessary precautions. 

The need for a stable mailing address also poses a barrier to those with housing instability. In the COVID-19 pandemic, widespread shipping delays can lead to gaps in contraception and thus pregnancy risk. Only OTC availability can give women rapid access to hormonal contraception that they can control immediately from time of acquisition.

Even before the COVID-19 pandemic abruptly exacerbated contraceptive access barriers, the American College of Obstetricians and Gynecologists (ACOG) published a committee opinion in support of OTC hormonal contraception 8 years ago.

 In the realm of oral contraceptive access, the OTC movement has been long in existence, with a broadly inclusive, multidisciplinary OC OTC working group founded over 15 years ago.

Professional organizations providing their support include ACOG, the American Academy of Pediatrics, American College of Nurse-Midwives, American Nurses Association, Association of Physician Assistants in Obstetrics & Gynecology, and Society of Adolescent Health and Medicine.

A wide range of reproductive health advocacy groups and justice organizations serve as partners in addition to university-based researchers and experts in the field.

 The American Academy of Family Physicians has maintained a clear position statement in favor of OTC hormonal contraception and makes the important distinction that insurance should provide coverage for these medications regardless of prescription or OTC status.

Despite long-standing interest in OTC hormonal contraception, we are greatly limited in our ability to conduct research due to FDA restriction of these medications as prescription-only.

As a result, we draw upon a growing body of literature from international contexts to supplement our domestic survey research. It is important to note that the United States is in the minority when it comes to restricting hormonal contraception to prescription-only status, with one global assessment revealing that only 45 of 147 countries have this limitation.

On a population level, the majority of the world’s population resides in countries with OTC access.

 Although OTC access is a common approach to hormonal contraception, there are important safety considerations as with all medications.

Switching a prescription-only hormonal contraceptive to OTC would require initial action from drug manufacturers. The company would need to submit a new drug application to the FDA that includes a risk assessment of the medication when accessed OTC and a risk-benefit assessment for consumers. 

Medication label and package inserts will be particularly important with OTC hormonal contraceptives as they would include self-screening instructions along with typical dosing and adverse effect information. Drug manufacturers and the FDA would need to ensure this information is comprehendible based on consumer reading levels and that it translates to correct contraceptive use.

Hormonal contraceptives are safe for the vast majority of women and adolescents. In a switch from provider-guided assessments, OTC provision will require individuals to self-screen for their own eligibility for both progestin-only and combined estrogen/progestin methods.

Venous thromboembolism (VTE) risk is a common safety concern with hormonal contraceptives. Fortunately, progestin-only methods, which include the progestin-only pill and subcutaneous depot-medroxyprogesterone acetate injection, carry no or minimal risk of VTE and do not require any in-person evaluation prior to initiation.

Estrogen-containing methods, which include COC, monthly vaginal ring, and transdermal patch, do carry a comparatively increased VTE risk in certain populations.

 However, the marginal increase in VTE risk among COC users is significantly lower than pregnancy or the postpartum time period.

OTC hormonal contraceptives would contain a checklist that potential purchasers could use to screen for medical conditions that would caution against self-use of these medications, particularly those that contain estrogen (Figure 2). 

Overall, studies have demonstrated that women tend to overestimate the risk of hormonal contraception and are more likely to restrict their own use more than what a medical provider would recommend. In one study, 6.9% of women reported contraindications to combined hormonal contraception while only 2.4% actually had a real contraindication on chart review.

Women in one study in the United Kingdom were so accurate in their self-assessment that none of the over 300 women included would have taken hormonal contraception contrary to medical guidelines.

Women could also be provided with guidance to determine whether they can be reasonably certain they are not currently pregnant.

 Some women may fall outside of these criteria and it is possible that they could start hormonal contraception with a clinically unrecognized pregnancy. 

Since these methods can alter women’s bleeding patterns and their overall suspicion for pregnancy, women who are not completely certain they aren’t currently pregnant could quick start their method and take a home pregnancy test in 2 weeks.

Additional guidance for backup contraception could be provided. Fortunately, if a woman does take hormonal contraception while pregnant, the exogenous hormones should not harm a developing pregnancy in the event she desires pregnancy continuation.

Contraceptive visits are often a time to review other aspects of a woman’s health. The Centers for Disease Control and Prevention’s 2016 

U.S. Selected Practice Recommendations for Contraceptive Use

 (SPR) advises against withholding contraception for breast exams, pelvic exams, sexually transmitted infection testing, or cervical cancer screening.

Though the SPR does recommend blood pressure measurement prior to starting estrogen-containing methods, women could use assessment from a recent health care visit or perform a self-measurement at a pharmacy or at home.

Decreased cost could be an additional benefit of OTC hormonal contraception since women would avoid office visit fees. The Affordable Care Act (2010) provided a federal contraceptive coverage guarantee that required private health plans to cover all 18 methods of FDA-approved contraception without co-pay or deductible.

General insurance coverage was also extended to dependents under the age of 26, spanning a large number of adolescent and adult contraceptive users.

Some states expanded contraceptive coverage, with 20 states and Washington, D.C., requiring insurers to cover dispensation of an extended supply of contraception at one time.

Given recent attempts by the current federal administration to weaken the contraceptive coverage guarantee, women may face cost concerns about whether their method is obtained with a prescription, from a pharmacist, or OTC. 

For policymakers, transitioning hormonal contraception to OTC status should not free it from insurance coverage. The place that a woman accesses her method should not be linked to the amount an insurance company will cover for the same medication.

As we navigate the global COVID-19 pandemic and anticipate our new normal, we need to ensure access to contraception. Reproductive planning is complex at baseline and a person’s interest in becoming pregnant may alter depending on their own personal experience during this time. From financial to medical concerns and everything in between, risk-benefit calculations regarding pregnancy will change.

Now is the time for drug companies to pursue OTC status for hormonal contraception. We need to empower people like my patient in their execution of their reproductive goals. With all the uncertainty in the world, access to hormonal contraception should be ensured.

Grossman D, Grindlay K, Li R, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013; 88:544-52.

Grindlay K, Grossman D. Interest in over-the-counter access to a progestin-only pill among women in the United States. Women’s Health Issues. 2018; 28(2): 144-51.

Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006–2010, and changes in patterns of use since 1995. National Health Statistics Reports. 2012; No. 60

Kavanaugh ML, Jerman J. Contraceptive method use in the United States: trends and characteristics between 2008 and 2014. Contraception. 2018; 97(1):14–21.

Pfizer. Depo-SubQ Provera 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use [package insert]; 2019. U.S. Food and Drug Administration website 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf

Grindlay K, Grossman D. Prescription birth control access among U.S. women at risk of unintended pregnancy. J Womens Health (Larchmt). 2016; 25: 249-54.

Approval of emergency contraception. 30 Achievements in Women’s Health in 30 Years (1984-2014). Updated 2019. Office on Women’s Health. US Dept of Health & Human Services. Accessed 4/25/20 at 

https://www.womenshealth.gov/30-achievements/19

Free The Pill. What’s the law in your state? Cambridge (MA): Ibis Reproductive Health; 2020. Accessed 4/25/20 at: 

Pharmacist Prescribing: Hormonal Contraceptives. National Alliance of State Pharmacy Associations; 2019. Accessed 4/25/20 at: 

https://naspa.us/resource/contraceptives/

Landau S, Besinque K, Chung F, et al. Pharmacist interest in and attitudes toward direct pharmacy access to hormonal contraception in the United States. J Am Pharm Assoc. 2009 ;49(1):43–50.

Richman AR, Daley EM, Baldwin J, et al. The role of pharmacists and emergency contraception: are pharmacists’ perceptions of emergency contraception predictive of their dispensing practices? Contraception. 2012; 86(4): 370–5.

American College of Obstetricians and Gynecologists. Over-the-Counter Access to Hormonal Contraception. ACOG Committee Opinion No. 788. Obstet Gynecol. 2019; 134 (4): e96-105.

OCs OTC Working Group. Cambridge (MA): Ibis Reproductive Health; 2020/ Accessed 4/24/20 at: 

American Academy of Family Physicians. Over-the-Counter Oral Contraceptives. 2014, Reaffirmed 2019. Accessed 4/21/20 at: 

https://www.aafp.org/about/policies/all/otc-oral-contraceptives.html

Grindlay K, Burns B, Grossman D. Prescription requirements and over-the-counter access to oral contraceptives: a global review. Contraception 2013;88(1):91–96.

Grossman D. Over-the-counter access to oral contraceptives. Obstet Gynecol Clin North Am. 2015; 42: 619-29.

HRA Pharma. A study of oral contraception under simulated OTC conditions (OPTION). ClinicalTrials.gov identifier: NCT03559010. Bethesda (MD): National Library of Medicine. Accessed 4/21/20 at: 

https://www.clinicaltrials.gov/ct2/show/NCT03559010

U.S. Food and Drug Administration. FDA Drug Safety Communication: updated information about the risks of blood clots in women taking birth control pills containing drospirenone. Silver Spring (MD): FDA; 2012. Accessed 4/21/20 at: 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-updated-information-about-risk-blood-clots-women-taking-birth-control

Tepper NK, Whiteman MK, Marchbanks PA, et al. Progestin-only contraception and thromboembolism: A systematic review. Contraception. 2016; 94:678-700.

Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016; 65 (RR-4): 1-66.

Xu H, Eisenberg DL, Madden T, et al. Medical contraindications in women seeking combined hormonal contraception. Am J Obstet Gynecol. 2014; 210: e 1-5.

Doshi JS, French RS, Evans HE, et al. Feasibility of a self-completed history questionnaire in women requesting repeat combined hormonal contraception. J Fam Plann Reprod Health Care. 2008; 34: 51-4.

Guttmacher Institute. State Laws and Policies. Insurance coverage of contraceptives. Accessed 4/15/20 at: 

https://www.guttmacher.org/state-policy/explore/insurance-coverage-contraceptives#

“This wouldn’t have happened if I was still in Brazil!” exclaimed my patient.

Now is the time for over-the-counter hormonal contraception

A 21-year-old G2P1001 was admitted on July 28 at 38 weeks, 4 days’ gestation for labor induction for a suspected large for gestational age (LGA) baby. The patient’s original estimated date of deliver was August 22. 

An ultrasound at 19 weeks, 6 days adjusted her date of delivery to August 7. The patient had a normal antepartum course, with normal antenatal screening, and normal glucose screening at 28 weeks’ gestation.

Two years earlier, the patient had given birth to an 8 lb, 10 oz male at term via an uncomplicated vaginal delivery with a three-degree extension.

During the current pregnancy, she was admitted at 33 weeks 0 days for possible preterm labor. Visual exam revealed a friable cervix, with 

. The patient was observed for approximately 21 hours, during which she received a dose of subcutaneous terbutaline, which led to diminished contractions, without significant cervical change. 

She was given a course of steroids and discharged on clindamycin and metronidazole.

On admission for labor induction on July 28, the patient’s diagnosis was advanced cervical dilatation and LGA. The admission history and physical documented a vertex presentation, with a cervix 3-cm dilated, 50% effaced, and a -2 station. The woman’s pelvis was described as “adequate.” 

Documentation did not include an estimated fetal weight (EFW). Induction proceeded with intravaginal prostaglandins, inserted at 7:30 am, with regular contractions beginning approximately 40 minutes thereafter. Fetal heart tones (FHTs) revealed a Type 1 pattern, with a baseline fetal heart rate (FHR) in the 140s. Augmentation of the patient’s labor with oxytocin was begun, at 2 mU/min.

Approximately 4 ½ hours later, at 12:05 p.m., the physician examined the patient. At that time, with oxytocin at 10 mU/min, her contractions were every 1 to 2 minutes, 60- to 70-mmHg in strength, with a continued Type 1 pattern. Her cervix was 4-cm dilated, 50% effaced, at a -2-3 station, with an occiput posterior position. Amniotomy revealed a small amount of clear fluid, and an internal FHR electrode was placed. 

An epidural was placed shortly thereafter. At 1:55 pm, with oxytocin at 12 mU/min, the patient’s cervix was 7- to 8-cm dilated, 90% effaced, at a 0+1 station. FHTs were in the 140s and, despite minimal variability, no decelerations were observed. At 3:45 pm, examination revealed a cervix with an anterior lip. 

No mention was made of the fetal station. The patient began pushing at 4:45 pm. FHTs were stable. The physician remained in the room while the patient pushed. Severe variable decelerations to the 60s started at 5 pm and the head was delivered at 5:10 pm and spontaneously rotated from right occiput posterior to occiput anterior position. The body did not immediately deliver. 

A McRoberts maneuver was used for 2 minutes and various maneuvers were performed to resolve a 6-minute shoulder dystocia. Fundal pressure was applied to assist with delivery of the body, which was accomplished at 5:18 pm. An 11 lb, 12 oz (5335 g) male was delivered with Apgar scores of 1, 6, and 8, at 1, 5, and 10 minutes, respectively. The arterial cord gases were pH = 7.19; pO2 = 23; pCO2 = 60; base excess = -7.0.

Then, and only then, first application of fundal pressure

Also described was an appropriate repair of a three-degree extension.

Subsequently, placental pathology revealed focal, mild, chronic non-specific chorionitis.

The newborn examination revealed bruising of the baby’s ears, face, chest, and right underarm. The right underarm bruising was consistent with traction to the armpit. There was no movement of the left arm. 

 while the pediatrician could not rule out a dislocation of the right shoulder. The left shoulder would have been the anterior shoulder at time of delivery. The baby had a low blood sugar at 37 and required an infusion of dextrox 10% in water.

The baby was transferred to an academic medical center. The admission physical revealed no movement of the left upper or lower arm. Radiologic studies revealed no dislocation of the left or right shoulder. 

revealed avulsion of the nerve roots on the left at C8 to T1, with mild displacement of the cord to the right. There was a possible subarachnoid hemorrhage. A cranial ultrasound was normal. Computed tomography of the head revealed no evidence of intracranial hemorrhage or displacement of the midline sutures. There was swelling on the right side of the face with minor asymmetry of the coronal suture.

A neurology consult confirmed Erb’s palsy, with a significant avulsion injury and complete left brachial plexus palsy. The neurologist opined that other roots may be torn more distally. There was probable right Horner’s syndrome, right torticollis, and a hoarse voice suggestive of laryngeal paresis.

Despite intensive physical therapy, there was no recovery of the function of the left upper extremity over 5 months, associated with mild ptosis of the left eyelid and ipsilateral pupil, consistent with Bernard-Homer Syndrome. 

The baby was referred to a pediatric neurosurgeon at another academic institution and underwent left brachial plexus exploration and external and internal neurolysis approximately 11 months after birth. Nerve grafting was not performed, as intraoperative electrical stimulation of the musculocutaneous nerve produced some visible and palpable contractions of the biceps brachii, and stimulation of the accessory nerve produced a similar response of the left deltoid muscle. 

Six weeks after surgery, the child was able to partially extend the elbow and flex his fingers. 

, there was no flexion at the elbow or extension of the fingers. Neurosurgery follow-up 4 months later (5 months postoperatively) identified no further recovery. The child continues with physical therapy.

Negligence in not offering the patient a primary cesarean delivery

Negligence in management of the shoulder dystocia

Damages including long-term care of the child, required long-term physical and occupational therapy, current and future pain and suffering, loss of future earnings, as well as emotional distress of the parents, and loss of consortium.

Following discovery, the defense elected to proceed with trial, as the case was deemed highly defensible.

At trial, the plaintiff’s experts noted that induction of labor for a LGA baby is not recommended by the American College of Obstetricians and Gynecologists (ACOG). Lack of an estimated fetal weight, either clinically or with ultrasound, was a breach of the standard of care. Had the physician estimated the weight as at least 5000 g, 

a primary cesarean delivery should have been pursued

Even with an estimated fetal weight > 4500 g, the risk of shoulder dystocia is up to 50%. The baby suffered permanent irreversible injuries that will require long-term physical and occupational therapy. The child will never have a normal life.

The defense experts testified that shoulder dystocia cannot be accurately predicted or prevented. None of the risk factors for macrosomia were present in this case, including preexisting diabetes and gestational diabetes, maternal obesity, excessive gestational weight gain, or abnormal antepartum glucose screening. 

The patient’s first baby weighed 8 lb, 10 oz or 3934 g and was delivered vaginal without difficulty. There was no clinical evidence of macrosomia, noting that the fundal height at 38 weeks was 39 cm.

Although an estimated fetal weight was not documented, the obstetrician deemed that the mother’s pelvis was adequate, evidence that there was consideration of the estimated fetal weight. 

Clinical and ultrasound estimates of fetal weight are poor indicators of actual fetal weight. Ultrasound is, at best, accurate to within 10% in estimating weight, and worse with larger babies.

Induction of labor is controversial. Earlier studies show an increased cesarean rate without a significant reduction in shoulder dystocia. Recent studies show induction of labor results in a four times reduction in the rate of shoulder dystocia. 

 even a primary cesarean delivery does not eliminate the risk of birth trauma and neonatal brachial plexus injury associated with macrosomia.

Further, most macrosomic babies do not experience shoulder dystocia. Finally, brachial plexus injuries can occur as a result of intrauterine positioning, not just a result of a shoulder dystocia.

The patient rapidly entered active labor following induction. She did not experience a prolonged labor, a prolonged second stage, nor was operative delivery required. Once the shoulder dystocia was encountered, all maneuvers were appropriate. The shoulder dystocia lasted 6 minutes, which is not an extended time. 

The umbilical cord gases were normal, evidence that the baby did not suffer any hypoxic compromise. The clinician’s contemporaneous documentation was excellent.

During rebuttal, the plaintiff’s experts again criticized the care, particularly the lack of documentation of an estimated fetal weight. If the estimated fetal weight had been less than 5000 g, attempting a vaginal delivery could have been justified. 

However, had the estimated fetal weight been 5000 g or greater, according to ACOG, a primary cesarean delivery should have been performed. The baby weighed 5335 g and thus, a cesarean delivery should have been performed. 

Further, in managing the shoulder dystocia, the documentation states, “the slightest amount of downward traction” was applied. Avulsion of the nerves does not occur without the application of excessive, improperly directed force. Avulsion injuries are not a result of intrauterine positioning. 

The baby has permanent injuries with paralysis of the left arm and distortion of his face, which will result in lack of social acceptance in the future. 

Defense experts testified that ACOG only states that a scheduled cesarean delivery may be beneficial and does not mandate that it be performed. The ACOG recommendations are based on expert opinion, not randomized trials. 

During the reparative surgery, there was evidence of some nerve conduction, thus the current disabilities may still respond to therapy in the future.

After 6 hours of deliberation, the jury found for the plaintiff, awarding $3.5 million.

This case was defensible, except for two major issues

: the lack of a pre-induction estimated fetal weight and the resulting nerve avulsion. The lack of an estimated fetal weight is not uncommon in shoulder dystocia cases resulting in litigation. Even though inaccurate, a clinical or ultrasound-based estimated fetal weight should be included in the initial assessment of all patients, whether for induction or in labor. Documentation of an estimated fetal weight, even if inaccurate, renders cases more defensible. 

Lack of such documentation, as in this case, is a major obstacle to successful defense. Avulsion of the nerve roots on the left at C8 to T1 was an additional impediment to successful defense. Plaintiff attorneys who frequently litigate shoulder dystocia cases often pursue only cases with nerve avulsion, as the forces required to cause avulsion have been shown to exceed the forces associated with the typical maneuvers used to manage shoulder dystocia. 

Further, avulsion injuries rarely recover spontaneously and require early surgical intervention, which if not successful, result in permanent disabilities. 

, the presence of the child in the courtroom throughout the trial was a constant visual reminder of his life-long disabilities.

This case involves induction of labor for a suspected large for gestational
age (LGA) baby in a mother with a normal antepartum course.

Shoulder dystocia: The unpredictable nightmare

Both natural and surgical premature menopause before age 40 are associated with a small but statistically significant increased risk for subsequent cardiovascular disease (CVD) compared to that in postmenopausal women without premature menopause, according to a cohort study in 

The composite outcome included coronary artery disease, heart failure, aortic stenosis, mitral regurgitation, atrial fibrillation, ischemic stroke, peripheral artery disease and venous thromboembolism.

The authors noted that although recent guidelines embrace using history of menopause before age 40 to refine atherosclerotic cardiovascular disease (ASCVD) risk assessments in middle-aged women, “robust data on cardiovascular disease risk in this population is lacking.”

The cohort of 144,260 eligible women was from the large-scale, long-term observational UK Biobank study, comprising adult residents of the United Kingdom recruited between 2006 and 2010. 

All included women were 40 to 69 years old (mean age 59.9) and postmenopausal at study enrollment, with median follow-up of 7 years through August 2016. Natural premature menopause was defined as menopause before age 40 without oophorectomy, while surgical premature menopause was bilateral oophorectomy before age 40.

Overall, 3.4% (n = 4,903) of women had natural premature menopause and 0.4% (n = 644) had surgical premature menopause. The primary outcome of incidence of composite CVD was 3.9% (n = 5,415) in women with no prema-ture menopause (5.7/1,000 woman-years) and 6.0% (n = 292) in women with natural premature menopause (8.78/1,000 woman-years), representing a difference vs. no premature menopause of +3.08/1,000 woman-years (95% confidence interval [CI]: 2.06 to 4.10; P < 0.001).

Among the 7.6% of women (n = 49) with surgical premature menopause (11.27/1,000 woman-years), the difference vs. no premature menopause was +5.57/1,000 woman-years (95% CI: 2.41 to 8.73; P < 0.001). 

Overall, natural and surgical premature menopause had hazard ratios of 1.36 (95% CI: 1.19 to 1.56; P < 0.001) and 1.87 (95% CI: 1.36 to 2.58; P < 0.001), respectively, after accounting for conventional CVD risk factors and menopausal hormone therapy.

The Framingham Heart Study found that a higher premenopausal Framingham risk factor was linked to earlier age at menopause. 

The current study, though, concluded that premature menopause may not be limited to comorbid with conventional CVD risk factors, but may separately increase odds of developing these risk factors. In addition, the study found that the CVD risk connected to premature menopause extended beyond ASCVD.

“Postmenopausal state is associated with increase in cytokines and oxidative stress, which may contribute to osteogenesis of valvular interstitial cells,” wrote the authors, noting that it is unknown if this mechanism links premature menopause to aortic stenosis.

Lastly, the form of menopause may be connected to differential cardiovascular risk. Although significant differences in risk between natural and surgical premature menopause were not evident in fully adjusted models, risk differences may arise from differential development of conventional cardiovascular risk facts. There is also the possibility the study had reduced statistical power.

Honigberg MC, Zekavat SM, Aragam K, et al. Association of premature natural and surgical menopause with incident cardio-vascular disease. JAMA. 2019. doi:10.1001/jama.2019.19191

The authors noted that, although recent guidelines embrace using history of menopause before age 40 to refine atherosclerotic cardiovascular disease (ASCVD) risk assessments in middle-aged women, “robust data on cardio-vascular disease risk in this population is lacking.”

Early menopause and cardiovascular disease

The 46-year-old plaintiff first presented to her primary care physician (PCP) on April 23, 2013, for a cough that had lasted 3 days. She reported incontinence, dribbling, and an inability to hold her urine after heavy menstruation. 

She also reported abdominal pain. Her PCP urged her to go to an ob/gyn for a work-up, with the differential possibly being endometriosis versus ruptured cyst. The impression was that the patient had recurrent stress urinary incontinence but the ob/gyn was concerned that it could turn into physical incontinence, given the woman’s gynecologic issues and age. 

 to send her for an ultrasound (U/S) of the pelvis, which was performed on May 1, 2013. The U/S revealed a very large uterine fibroid (7x7 cm).

On May 5, 2013, the plaintiff presented to nonparty hospital with complaints of lower abdominal pain and vaginal bleeding that had lasted for 2 days. She reported bright red blood with multiple clots that increased throughout the day and her diagnosis with a 7x7-cm uterine fibroid by her PCP but said she did not have an ob/gyn. 

On exam, she reported that she had a history of heavy menses secondary to the fibroid. Transvaginal (TVUS) confirmed multiple fibroids, the largest being 8.7 cm, and an enlarged uterus (8.5 x 12.2 cm). The impression was leiomyoma of the uterus. The woman was sent home in stable condition that night because she felt better, with a directive to follow up with an ob/gyn that week.

The plaintiff saw her PCP on July 23, 2013, for the start of preoperative medical clearance for a hysterectomy. She was cleared for surgery. 

, she reported incontinence and dribbling and that she could not hold her urine after menstruating. The assessment was vaginal bleeding, with abdominal pain secondary to the abdominal fibroids.

On or about August 26, 2013, the plaintiff presented to Defendant Hospital A for a laparoscopic hysterectomy by 

, secondary to bleeding fibroids. The plaintiff’s history included a cesarean delivery, open cholecystectomy, bilateral breast reduction, and treatment for a miscarriage. During the hysterectomy, she sustained a bladder injury. 

An intraoperative cystoscopy confirmed a 2-cm tear near the vaginal cuff. Two double-J ureteral stents were placed by Defendant urologist, who recommended that she be transferred to Defendant Hospital B. The woman’s bladder was not repaired intraoperatively; instead she was transferred after Defendant ob/gyn A spoke with 

 is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense and healthcare litigation. This case was handled by one of his partners.

On August 27 at 11:40 p.m., the plaintiff was transferred from Defendant Hospital A to Defendant Hospital B with an admitting diagnosis of injury to the bladder and urethra and open wound. The admitting physician was Defendant ob/gyn B, who attempted conservative management; for 48 hours, the patient was stable without any issues. 

On August 29, a decision was made to perform a cystoscopy to further evaluate the bladder injury. Defendant ob/gyn B’s operative report indicated that informed consent was obtained. A cystogram was performed using 200 mL of fluid without obvious contrast extravasation. The plaintiff’s Foley catheter was removed and the two previously placed double-J stents were identified and noted to be in good position. 

A cystoscopy then was performed, and at the level of the trigone in the posterior portion of the bladder, an area consistent with the intraoperative injury was found. The same was noted to have granulating tissue but no obvious tear or extraperitoneal leak was seen. 

, Defendant ob/gyn B decided “to not proceed with a formal repair” and instead, decided to continue to conservatively manage the plaintiff. 

The Foley catheter was replaced and the report concluded with a comment that the patient was to follow up in the office within the next 2 weeks for a repeat cystoscopy and removal of the double-J stents that had been placed. In the Postoperative Acute Care Unit, she received 2 units of blood. Discharge was on August 30.

A day later, the plaintiff was readmitted to Defendant Hospital B complaining of no urine output from the Foley catheter for 12 hours, lower abdominal pain, and difficulty breathing. The catheter was changed in the ER without relief of symptoms, so the plaintiff was admitted. 

On U/S, her bladder was small with fluid around it. A computed tomography (CT) scan showed that the Foley catheter was out of the bladder and in the peritoneum. The catheter was repositioned and conservative management was attempted. 

 the patient had desaturations in oxygen to the 80s and was found to have bilateral pulmonary embolisms (PEs). Dopplers came back negative for deep vein thrombosis. 

Because of the woman’s history of PEs, a removable inferior vena cava filter was placed by vascular surgery. An intravenous (IV) Heparin drip also was started. The plan was to stabilize the patient medically and then take her to the operating room (OR) for an open bladder repair.

On September 3, repair surgery was undertaken by Defendant ob/gyn B. The procedure was described as an open complex cystorrhaphy with a repair of bladder injury and placement of a suprapubic tube. Per the OR report, “due to the location of the injury at the level of the trigone, a decision was made to perform an intravesical repair.” 

Allegations in this complex case include negligence in performing laparoscopic hysterectomy and delaying treatment of bladder injury.

July 2020 | Vol 65 No 07

Domestic violence reports increase in two major cities during COVID-19

Now is the time for over-the-counter hormonal contraception

Shoulder dystocia: The unpredictable nightmare

Early menopause and cardiovascular disease

Did delay in bladder repair cause urologic issues?

Improving risk outcomes: Invasive breast cancer after DCIS

NIH launches clinical trials network to test COVID-19 vaccines and prevention strategies

Aromatase inhibitors for climacteric symptoms in women with breast cancer

Risk factors for candidiasis

Inducing labor to reduce stillbirths