State policies targeting drug and alcohol use during pregnancy have increased in number since 1974 and have become more punitive over time, according to a recent study of all statutes and regulations in the United States that pertain to the use of drugs or alcohol by pregnant women.

This study, conducted by the Pacific Institute for Research and Evaluation (PIRE) and the University of California, San Francisco, examined data from 1970 through 2016. Trends in individual types of policies were defined, as well as overall trends in policies state-to-state. The results of these studies were then compared to one another to build a more complete picture of the policy environment in the United States pertaining to pregnant women and substance use.

There were several policy types defined as part of the study. Punitive policies seek to control the behavior of the pregnant woman. Proponents of these policies maintain that restricting a woman’s access to drugs or alcohol is the best way to ensure the health of the pregnancy and the fetus, that the state has a duty to prevent the lifelong problems that affected children may experience including, if necessary, separating children from their parents.

Supportive policies seek to provide support services to pregnant women and families and do not attempt to threaten or coerce. Services might include education, early intervention, support or treatment. Mixed policies contain aspects of both punitive and supportive interventions. 

To define policy types, researchers identified a group of variables by which policies were rated. The variables were used to analyze individual policies and the overall policy environment for each state. The variables included:

Requirements for mandatory warning signs, mostly aimed at retail cannabis establishments.

Priority treatment policies, either for pregnant women only or for both pregnant women and women with children.

Prohibitions on using the results of medical testing as a part of criminal prosecution related to health of a fetus or child.

Mandatory involuntary commitment of a woman to a treatment facility or to the care of the state because of her substance abuse. 

Reporting requirements, either to Childrens Protective Services (CPS)to assess risks of child abuse or neglect, or for data and treatment purposes only.

Presence of statues or regulations that define the rules related to child abuse or neglect.


In 1980 only one state had a drug and pregnancy policy; by 10 years later that number had risen to 16 states. By 2000, 31 states had at least one policy, and by 2016 the number had climbed to 43.
 


After all data were analyzed, several key findings were identified:

By 2016 almost 85% of states had policies regarding drug use during pregnancy.

Policies regarding drug use during pregnancy have become less supportive over time.

Policies regarding drug use during pregnancy are often punitive, while most policies regarding alcohol use during pregnancy are supportive.

Also noted was that punitive policies place a disproportionate burden on low-income women and women of color, as such policies appear to deter women from seeking needed care. Even supportive care policies that provide direct services or support are not always readily available to disadvantaged women, further compromising their health and the health of their children. 

Missing from this study and a possible area of focus for future studies is the lack of ethnographic data as well as interactions between the policies and the overall social environments of the women in the different states. Further research may also focus on the reasons why some policies were enacted rather than others, and how states have enforced these policies. 

Articles

State policies targeting drug and alcohol use during pregnancy have increased in number and have become more punitive, but findings show that these policies may not encourage women to seek the needed care.

Comparing policies on drug and alcohol use by pregnant women

Seventy-five ob/gyn residents took part in the Sixth Annual Gottesfeld-Hohler (GOHO) Memorial Foundation Resident Ultrasound Boot Camp at Mount Sinai Health System in New York on August 4 and 5. The PGY 2s attended lectures on a variety of topics including basic ultrasound in the first and second trimesters, the placenta, the cervix, twins and gynecologic ultrasound. 

Then, the group walked over to the Mount Sinai clinical offices, where they scanned pregnant women under the guidance of some of the most experienced professors in ultrasound. 

The 2-day course is offered free of charge to PGY 2s as part of the GOHO Foundation’s mission of ultrasound education. 

Drs. Aleha Aziz, Angela Bianco, Eran Bornstein, Joshua Copel, George Doulaveris, Keith Eddleman, Natie Fox, Ana Monteagudo, Andrei Rebarber, Pat Rekawek, Lynne Simpson, Joanne Stone, Ilan Timor-Tritsch, Lucy Vieira and Brian Wagner volunteered their time to teach the residents how to scan. They covered basic and advanced fetal biometry and information on identifying fetal anatomy. The residents practiced gynecologic ultrasound on simulation machines.

Mount Sinai sonographer Dalia Sapoznikow, RDMS, Assistant Supervisor of Ultrasound in the Maternal Fetal Medicine department, recruited the models, and administrator Tara Jefferson coordinated all the logistics for the event at Mount Sinai Hospital. 

The boot camp was sponsored by Philips, GE, and Samsung. Trice Imaging sent ultrasound images to all the patients, and SonoSim and MedaPhor provided simulators for vaginal scanning.

The Gottesfeld-Hohler Memorial Foundation

 is a 501(c)(3) charity was founded by Drs. Larry Platt and John Hobbins along with two of the founders of the former ADR Ultrasound, Jim Binns and Marty Wilcox, to honor two early pioneers of ob/gyn ultrasound, Ken Gottesfeld and Chuck Hohler. The Foundation organizes a fundraising ultrasound course in Florida every December, with all proceeds going toward the educational mission of the group. This year the Foundation will hold an additional free educational program for MFM fellows during that program.

Gottesfeld-Hohler Memorial Foundation sponsors 6th annual hands-on ultrasound course for residents

Electronic records are ubiquitous. Whether confined to one provider or group’s record of a patient’s care, the electronic medical record (EMR) or the comprehensive record of a patient’s entire care, the electronic health record (EHR), are now the standard for documenting a patient’s care. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 authorized grants and incentives totaling an estimated $28 billion to promote “meaningful use” of EHRs by providers.

 In recent years, EHRs have become somewhat more user-friendly, allowing customization to enhance efficiency and access to critical information in a patient’s record. The benefits are tangible, but new risks with EHRs are becoming evident. 

EHRs offer opportunities. With them, there is no question that records are legible, a significant improvement over hand-written accounts. When EHRs are complete, they enhance the quality of patient care and potentially reduce errors. Access to a patient’s complete history allows all treating providers to coordinate care and communicate about the patient’s care. EHRs offer rapid access to imaging studies, laboratory findings, pathology, and outside records, improving efficiency and care coordination. Better documentation of clinical decisions and activity, through both user-entered data and metadata, may improve the ability to defend against malpractice claims when care was appropriate. Automatic alerts warn physicians about a patient’s allergies, potential harmful drug interactions, and caution about use of medications that may be contraindicated based on a patient’s medical conditions. Care pathways offer consistent, evidence-based guidelines to enhance care and minimize complications. Ultimately, universal access to care wherever a patient is seen would markedly enhance efficiency and quality. 

EHRs also present new challenges and risks. Liability can be increased based on inherent designs. Templates bring in data and assessments that may not have been performed or reviewed. Copying and pasting potentially propagates errors in documentation. Many “assessments” in EHRs merely list the diagnoses associated with the visit. Failure to document one’s thought process, assessment of the potential causes of the condition, and a thorough differential diagnosis reduces defensibility (Kevin J. Kuhn Esq., Wheeler Trigg O’Donnell LLP, Denver, Colorado, personal communication, June 22, 2018). 

Most juries understand physician judgment. Unfortunately, documentation in EHRs may not reflect this judgment. The ability to access all facets of the patient’s care could create a duty to act on the information. Even worse, metadata will document if the provider reviewed critical documentation found elsewhere in the record. Deviation from care guidelines and clinical-decision guidelines may bolster the plaintiff’s case. Academic environments add an additional risk, as attendings must attest to the assessment and treatment plans of trainees. It is incumbent on the attending to read the entire note and ensure that all facets of the documented exam were performed, assessments are complete, and treatment plans appropriate. Failing to adequately review the documentation can expose the attending to liability. 

What is metadata? In short, it is data about data. Both EHRs and EMRs automatically generate a time stamp that documents who accessed the document, what was accessed and when, where access occurred, and even how long someone was in the record. 

Physicians facing a suit may be tempted to review the record and clarify some salient points. That is fraught with much risk, particularly in the era of EHRs, with their inherent metadata. Today, it is not enough to defend just the medical record. Now one must defend the metadata. 

An audit trail is metadata that records who, when, where, how and sometimes why a person accessed a patient’s medical record. Typically, the identity of the user who accesses the patient’s record, the time of access, the terminal or device used for access, the action taken by the user (i.e., viewing the record, changing the record), and the substance of anything added to the record and any changes or corrections made by the user are recorded in the metadata, which can be reproduced in the form of an audit trail or log.

 To emphasize the level of detail available, one study by a surgery department assessed preoperative review of computed tomography scans.

 The researchers were able to determine which residents accessed the record, whether just the report was viewed, if the images were viewed, how many images were viewed, and for how long. The authors found that senior residents viewed more images than junior residents or family medicine residents. 

Of note, an audit trail only records who is logged into the computer. Thus, if an attending reviews the images with a resident who is logged in, the audit trail will not reflect that the attending viewed any images. The authors recommended that the attending login separately to view imaging studies and laboratory results to provide electronic confirmation of his or her involvement in a patient’s care. Without such documentation in the metadata, a rebuttable presumption is that the surgeon never looked at the images. 

In an obstetrical case with an adverse newborn outcome, the nurses’ records document that Dr. X was notified of late decelerations. Shortly thereafter, the nurses again documented that they notified Dr. X of late decelerations. Dr. X testified that he reviewed the fetal heart rate (FHR) monitor remotely and the decelerations were not ominous. Metadata demonstrated that Dr. X failed to review the FHR recordings, even remotely. Remember, metadata shows who accessed the EHR, when and where. Dr. X’s credibility was severely damaged. The case was settled for an undisclosed amount. 

Unnecessary hysterectomy with complications

A patient underwent a laparoscopic hysterectomy and suffered a bowel injury. The liability action included a claim of performing unnecessary surgery. At deposition, the surgeon testified that he had fully reviewed all studies in anticipation of the surgery. Multiple experts were deposed supporting the indications for hysterectomy and the surgeon’s performance of the surgery. 

A subsequent audit of the metadata, however, demonstrated that the surgeon did not access the studies until after the suit was filed. Further, it demonstrated that the surgeon had not reviewed pertinent lab results prior to surgery. Even worse, the surgeon altered the record to justify the surgery, with the timing of the alteration found in the metadata. The credibility of the surgeon’s testimony was destroyed, he committed perjury, and the case settled. Further, sanctions were filed against the surgeon because the expert depositions were based on fallacious information. The surgeon paid $90,000 in restoration of the plaintiff attorney’s expenses and is facing possible loss of his license by the state board of medicine. 

How common is alteration of the medical record? One plaintiff’s attorney estimated that 25% of cases involve alteration of the medical record (Personal communication, anonymous plaintiff attorney, June 20, 2018). As such, an audit trail expert is hired for every case. This expert examines the digital footprint of record, determining if there have been deletions, alterations, or modifications to the record. This has resulted in settlement of a number of cases-particularly if the modifications occurred after litigation began-that perhaps otherwise would have been defensible. Experts in metadata also advise the attorney on questions to ask to establish this type of evidence. 

An EHR has the ability to generate templates for specific diagnoses or symptoms, which can be convenient and efficient. But errors in data entry can be propagated by copying and pasting. When discovered, a “correction” should be made. Corrections are changes in a patient’s medical record during the normal course of treatment.

 A change made prior to the issue of a claim or lawsuit would be considered a correction. Corrections are acceptable provided they are made appropriately. 

Institutions and practices should establish a policy for appropriate medical record corrections. Typically an addendum is made to the medical record, denoting the date, time, and author of the correction and the reason for it.

 Striking through the erroneous entry with a single line is preferable. If appropriate, attention should be directed from the erroneous entry to the corrected entry. Once the correction is made, the erroneous entry should not be removed or deleted because it may have been relied upon by other health care team members.

 Removing or deleting such data alters the integrity of the medical record. Authorized and transparent alterations are considered a testament to the medical record’s accuracy, freedom from unauthorized alterations, and completeness.

 When done appropriately, these corrections will not be construed as altering the medical record. 

In contrast, an “alteration” is when a provider receives a notice of suit and then goes to the medical record to “clarify” certain points, particularly for the purpose of aiding defense of the claim. Such alterations are considered a deliberate misrepresentation of the facts. Discovering such alterations during litigation severely impacts the ability to defend a claim. Further, many liability policies exclude coverage for claims in which the medical record was altered. Providers must not alter the medical record after receiving notice of a claim. In addition, after receiving notice of claim, physicians should refrain from accessing the medical records without first speaking with their liability carrier or legal counsel. Such access infers the possibility of record alteration. 

EHRs offer great benefits with some potential new areas of liability. However, proper and timely documentation enhances the defense in liability actions. Metadata will become the standard when integrity of an EHR is questioned. “Metadata is evidence, typically stored electronically, that describes the characteristics, origins, usage and validity of other electronic evidence.”

 According to one attorney, “Metadata is discoverable evidence that our clients are obliged to preserve and produce. Metadata sheds light on the origins, context, authenticity, reliability and distribution of electronic evidence, as well as providing clues to human behavior. It’s the electronic equivalent of DNA, ballistics and fingerprint evidence, with a comparable power to exonerate and incriminate.”

 A special thanks to Kevin J. Kuhn, Esq., a defense attorney with Wheeler Trigg O’Donnell, LLP, Denver, Colorado, for his insight and defense perspective on electronic health records. Also, a special thanks to the anonymous plaintiff attorney for his perspective on metadata and the use of audit trails in litigation. 

Mangalmurti S, Murtagh L, Mello MM. Medical malpractice liability in the age of electronic health records. N Engl J Med. 2010;363(21):2060-2067.

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McLean T, Burton L, Haller C, McLean P. Electronic medical record metadata: uses and liability. J Am Coll Surg. 2008;206:405-411.

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Samaritan G. correcting ehr erros without getting into trouble. Medscape. 2013. 

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Norton C, D’Amico M. The Electronic Medical Record, Audit Logs and Revision History. 

www.damicopettinicchi.com/scholarly-articles/the-electronic-medical-record-audit-logs-and-revision-history.html

Ball C. Beyond data about data: the litigator’s guide to metadata. 2005. 

http://www.craigball.com/metadataguide2011.pdf

Metadata from an EHR form an audit trail of activity, which can make or break a malpractice case.

Electronic records and metadata: Old and new liability risks

There are several concrete steps clinicians can take to lessen the likelihood of vaginal birth complications, whether stemming from shoulder dystocia, a second twin or vaginal breech.

Having a protocol in place and simulation rehearsing with the entire medical team are two techniques proven to reduce complications.

“Often these complications are unexpected,” said 

 Editor-in-Chief Charles J. Lockwood, MD, MHCM. “For example, with shoulder dystocia, it is extremely difficult to predict who is at risk. And even when you predict those at risk, the patient usually does not have shoulder dystocia.”

Because a shoulder dystocia is typically unanticipated, “it is critical that clinicians have in mind a set protocol of steps to take in order to optimize outcomes,” said Dr. Lockwood. “It is also really important to document what you did and why you did it, so you have a credible defense, should there be an adverse outcome and you end up being sued.”

Shoulder dystocia occurs when the fetal head delivers but the shoulders do not deliver with normal maneuvers. It is one of the few emergencies encountered during labor that an urgent cesarean delivery or surgery cannot correct.

Hence, shoulder dystocia needs to be remedied with the maneuvers that the obstetrician is already trained in, according to Amy Mackey, MD, ob/gyn Residency Program Director at Abington Hospital-Jefferson Health in the Philadelphia area. Simulation and team training can also lessen some of the anxiety surrounding the event.

Incidence of shoulder dystocia ranges between 0.2% and 3%. “This wide range is due to subjectivity at the time of delivery as to what constitutes a shoulder dystocia,” said Dr. Mackey. “The definition that most people follow is a difficult shoulder delivery that does not resolve with gentle downward traction and requires additional obstetric maneuvers.”

A previous shoulder dystocia during delivery is the strongest risk factor. Other risk factors include operative delivery, maternal obesity, maternal diabetes, fetal macrosomia, a prolonged second stage and a precipitous delivery.

When encountering a shoulder dystocia, the positioning of the mother is the first consideration. “The patient should be brought down on the bed, so that the bed does not obstruct your ability to perform gentle, downward traction,” Dr. Mackey told 

. “Also, make sure you have a stool in the room and that you have someone ready to exert suprapubic pressure. That team effort is really important, so preparation is key.”

In addition, the axis of the force applied for downward traction is important to decrease the strain on the brachial plexus.

Dr. Mackey said it is important not to panic when a shoulder dystocia is encountered. “Force is measured in newtons, which has an exponential time component in the denominator,” she said. “The faster you apply pressure to the baby’s neck, the greater the force will be on the brachial plexus. Therefore, slow and gradual increase in pressure will be better tolerated by the fetus.”

Some physicians advocate delivering the posterior arm after performing the McRoberts Maneuver and suprapubic pressure as better than rotational maneuvers to alleviate shoulder dystocia. “But this is controversial,” said Dr. Mackey. “It really depends on the clinical situation.”

Dr. Mackey said the order of the maneuvers is less important than having a standardized approach. “You want everyone in the room to be able to anticipate what will happen next,” she said. “For us, the provider repeats all the maneuvers. If the provider is still unsuccessful at achieving delivery, a second provider tries.”

Dr. Mackey said obstetricians should never exert fundal pressure. “There is a higher incidence of permanent brachial plexus injury if you use fundal pressure at the time of a vaginal delivery with shoulder dystocia,” she said.

The maneuvers performed for shoulder dystocia are intended to prevent hypoxic injury to the baby. “The time that you have from the time you encounter shoulder dystocia to the time that the baby needs to be delivered is variable, based on the status of the baby going into the delivery,” said Dr. Mackey. “For example, if you have a baby that is well-oxygenated, you are going to have more time than if you have a baby that is borderline to relieve the shoulder to prevent hypoxic injury.”

Once a shoulder dystocia is resolved, the obstetrician must stay alert to postpartum complications. “Postpartum hemorrhage and third- and fourth-degree lacerations are increased in women who experience a shoulder dystocia,” said Dr. Mackey. 

In contrast to shoulder dystocia, a second twin is more often than not an anticipated potential complication. “The problem often results from an unstable lie,” Dr. Lockwood said. “In other words, as the second twin is coming down, you might think it is coming down vertex and then it flips, or it might be coming down breech and then it becomes transverse. The challenge is understanding the fluidity of that situation.”

As with shoulder dystocia, having a plan in place for effectively delivering that second twin is critical, whether that be an internal podalic version, an external version or a normal vaginal delivery in the vertex position.

“You want to also ensure that there is an adequate medical team available, including enough staff to perform a stat C-section, if needed,” Dr. Lockwood said. “In addition, there needs to be someone to help guide the second twin into the pelvis and someone to monitor the heart rate and other vital signs.”

Delivering the second twin can be tricky, according to Dr. Lockwood. “You can have ruptured membranes, or the umbilical cord can prolapse or present before the baby,” he said. “Occasionally there is even vasa previa and other complications that necessitate rapid action.”

Prevalence of vaginal delivery of twins, both vertex and breech, has increased over the years at Brigham and Women’s Hospital in Boston, paralleling a decrease in incidence of cesarean birth, possibly due to a comprehensive program entailing patient counseling, staff simulation training and an available team for twin deliveries.

“Although the literature about the delivery of twins is understandably limited, we believe that vaginal delivery is generally a safe thing to do,” said Julian Robinson, MD, Chief of Obstetrics at Brigham and Women’s Hospital, in Boston. “However, there is no optimal technique that can be used for delivery of the second twin. Furthermore, the choice of technique may change as the case progresses.”

 that traditionally, obstetricians tend to favor a single technique for all situations.

Dr. Robinson counsels families that if the first twin is breech, both twins are delivered via cesarean. But if the first twin is head down, a vaginal delivery is planned for both twins, unless there is a good reason not to do so, such as the second twin being much larger than the first.

“We also factor in maternal wishes,” said Dr. Robinson. “For example, if the mother is very keen on having a C-section delivery rather than a vaginal delivery, we honor that request.”

In the case of both twins being head down, one approach is to be fairly hands off. “You deliver the first baby and then stabilize the lie of the second baby, head down,” said Dr. Robinson. “You actually let the second baby labor down before rupturing the membranes, so the head is well engaged.”

This approach is much more suitable for mothers who have previously delivered. “But for the mother who has not had a baby before, we are more proactive with early rupture of the membranes,” said Dr. Robinson. 

In this scenario, Dr. Robinson rarely uses a high vacuum to pull the baby down quickly (a technique that he used to use preferentially) because the vacuum tends to disengage, plus it avoids two different instruments for vaginal delivery, such as vacuum and forceps.

A second method to consider is to deliver the first twin vaginally and the second twin breech, if the head of the second twin is high but surrounded by amniotic fluid. “You change the second baby to a breech presentation by an internal podalic version for an almost instantaneous delivery,” said Dr. Robinson.

Dr. Robinson said mothers do not want a vaginal delivery of the first baby and a cesarean for the second. “What increases the probability of a C-section is the length of time between the delivery of the first and second baby,” he said. “The longer the wait, the more likely something will go wrong, like bleeding or a nonreassuring fetal heart rate, which precipitates intervention with a C-section.”

Organization and planning ahead are key to increasing the odds of a vaginal delivery of twins. What are the roles of each member of the obstetric team? What does the mother want? 

Logistically, will the twins be delivered in a labor room or the operating room (OR)? “Personally, I tell all my patients we are going to deliver in the OR, not because we think there is going to be an increased chance of an operation, but because we want the space,” said Dr. Robinson. “It takes a lot of room, particularly when you bring in two separate pediatric teams.” 

Independent of twins, with breech birth there is always the possibility of a woman presenting to labor and delivery fully dilated with the breech at the perineum, in which case there is no time for a cesarean. “Therefore, it is important in that circumstance to know how to deliver the vaginal breech,” Dr. Lockwood said.

Similarly, in the case of a woman desiring a planned vaginal breech delivery, the clinician should aim for a good outcome that is safe.

“Sometimes you can have trouble delivering breeches at C-section, so having a good C-section technique available is also important,” Dr. Lockwood said. 

Documenting every aspect of the delivery, whatever the means, is critical.

Learning several simple skills can make a breech birth safer for both mother and baby. “Upright vaginal breech is actually an easier way to deliver the babies breech,” said Annette Fineberg, MD, an ob/gyn at Sutter Medical Group in Davis, Calif. “Gravity, combined with 1 to 2 cm of extra space, results in rarely needing forceps or complicated maneuvers.”

 that when the baby is in the upright position, gravity helps the baby be born. “The baby is able to rotate and flex on its own,” she said. “By knowing what is supposed to happen, you then know when to intervene. A lot of times, the birth will happen on its own. In essence, hands off the breech, unless there is a danger sign.”

Many of the tips Dr. Fineberg shared originate from Frank Louwen, MD, an ob/gyn in Frankfurt, Germany, and his colleagues.

In the case of a surprise breech, when the mother is starting to deliver, “it is best for the mother to get on her hands and knees,” said Dr. Fineberg. “The baby will then perform specific maneuvers to get itself out. If the baby does not rotate properly, you know there is a problem.”

Likewise, if there is no crease in the baby’s chest, “you may need to do a LÃ¸vset maneuver to retrieve a nuchal arm,” said Dr. Fineberg. 

“The baby has a limited time to get out. With a reassuring fetal heart rate and a vigorous infant, you have about five minutes,” said Dr. Fineberg. 

Conversely, ob/gyns need to know when to abandon a breech birth and deliver by cesarean instead. “If the baby is not following the expected rotation and descent, you are probably better off pushing the baby up,” said Dr. Fineberg. 

Dr. Fineberg has heard numerous stories of mothers being placed at risk, when in reality the baby was simply trying to come out on its own. “For example, a mother having her fifth baby at 36 weeks is put under general anesthesia after a full meal,” she said. “If the mother had been able to push instead, the baby probably would have been born in five minutes.” 

Good candidates for vaginal breech delivery are mothers who are at least 36 to 37 weeks’ pregnant, frank or complete breech, spontaneous labor progressing, normal descent, adequate pelvis and an estimated fetal weight between 2,500 and 4,000 g. 

“MRI pelvimetry is not absolutely needed, but it can decrease the odds of needing an intrapartum cesarean,” said Dr. Fineberg. 

A growth-restricted or preterm baby is actually more dangerous for breech delivery than a large baby because the body can be small and the head bigger in proportion.

For an unplanned breech birth, the two signs of an adequate pelvis are rapidly progressing cervical dilation and rapid decent of the baby. “You should also check the fetal head position with ultrasound,” said Dr. Fineberg.

One newer technique to increase safety during breech delivery is a shoulder press, “You apply pressure at the midclavicular line, which causes a reflexive tuck of the chin,” said Dr. Fineberg.

Most obstetricians learn to perform a routine episiotomy for breech, especially with a first-time birth. “But an intact perineum can often help the baby flex its own head,” said Dr. Fineberg.

Many studies published since 2000 have been encouraging about risk of a vaginal breech. “There is no question that vaginal breech babies have lower Apgar scores than C-section babies, but the incidence of serious long-term complications is not significantly different between the two techniques,” said Dr. Fineberg.

Based on more recent optimistic clinical studies, organizations in UK, Canada and the American College of Obstetricians and Gynecologists (ACOG) now have published more positive breech guidelines. In August, ACOG issued an interim update of its committee opinion on term singleton breech delivery (https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Mode-of-Term-Singleton-Breech-Delivery). “The main problem, though, is that most obstetricians have not learned how to deliver babies breech,” said Dr. Fineberg.

For an unplanned breach or an emergency situation, “I want the ob/gyn to feel more safe and comfortable performing a vaginal breech,” said Dr. Fineberg said. “I would also like to see referral centers, so mothers have an option.” 

For all vaginal birth complications, training the entire staff with simulation year-round is vital, “so when the actual emergency occurs, the staff is ready and knows exactly what to do,” Dr. Lockwood said. “The team is prepared to proceed in a very orderly and logical fashion, with a minimum of chaos. That will minimize errors.”

Likewise, for all scenarios, “you want to have a protocol in mind that is burned and seared into your memory,” Dr. Lockwood said. “You do not want to panic when confronted with any of these emergencies.”

Dr. Mackey reports no relevant financial disclosures.
	Dr. Robinson reports no relevant financial disclosures.
	Dr. Fineberg reports no relevant financial disclosures.
	Dr. Lockwood is the editor-in-chief of Contemporary OB/GYN magazine.

Mode of term singleton breech delivery. ACOG Committee Opinion No. 745. American College of Obstetricians and Gynecologists. 

American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 178: Shoulder Dystocia. 

American College of Obstetricians and Gynecologists’ Committee on Practice Bullets-Obstetrics. Practice Bulletin No. 161: External Cephalic Version. 

American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics; Practice Bulletin No. 169: Summary: Multifetal Gestations: Twin, Triplet, and Higher-Order Multifetal Pregnancies. 

Whyte H, Hannah ME, Saigal S, Hannah WJ, Hewson S, Amankwah K, et al. Outcomes of children at 2 years after planned cesarean birth versus planned vaginal birth for breech presentation at term: the International Randomized Term Breech Trial. Term Breech Trial Collaborative Group. 

Hannah ME, Whyte H, Hannah WJ, Hewson S, Amankwah K, Cheng M, et al. Maternal outcomes at 2 years after planned cesarean section versus planned vaginal birth for breech presentation at term: the international randomized Term Breech Trial. Term Breech Trial Collaborative Group. 

Su M, Hannah WJ, Willan A, Ross S, Hannah ME. Planned caesarean section decreases the risk of adverse perinatal outcome due to both labour and delivery complications in the Term Breech Trial. Term Breech Trial Collaborative Group. 

How to minimize vaginal birth complications

As practicing obstetrician-gynecologists in a safety-net hospital, we strongly support Title X and are dismayed by a proposed federal rule change

threatening to severely compromise it. We are privileged to serve beneficiaries of Title X, the only federal grant program that guarantees contraceptive access for low-income women, and we see the positive impact the program has on their lives and health. In New Mexico, where we practice, a large percentage of women receive services through Title X.

With one of the country’s highest adolescent pregnancy rates and a high rate of medically complex patients, Title X allows New Mexican women of all ages to make positive health choices. 

Enacted in 1970 during the Nixon administration, Title X drew bipartisan support with no dissenting votes in the Senate and only 32 dissenting votes in the House, demonstrating the overwhelming support for family planning as an integral component of preventive health care. The broad base of support came from a shared understanding that greater access to birth control would lead to fewer abortions by reducing unintended pregnancies. 

Since enactment, Title X has become a critical safety net providing comprehensive contraceptive services to underserved women. Providers are required to follow quality guidelines mandating evidence-based practices, including the provision of the full range of FDA-approved methods. Research confirms that Title X centers are more likely than others to provide a broad array of contraceptives, including highly effective long-acting reversible contraceptives (LARC) and to employ protocols that facilitate the initial and continued use of contraception by patients.

The proposed regulatory changes to Title X would severely undermine the program’s success. At risk is care that complies with the Institute of Medicine’s six dimensions of quality: care that is safe, timely, patient-centered, effective, efficient and equitable. The proposed binding rule restricts providers’ ability to offer the evidence-based contraceptive care and reproductive health counseling known to result in improved health outcomes.

Although evidence is clear that abortion rates are lowest in regions that invest in family planning services, this ill-conceived rule change promotes less effective contraceptive methods and reduces access to abortion. We explain only a few of the many damaging components of the rule: 

The rule undermines access to comprehensive contraception through several mechanisms. One is the removal of the requirement for provision of “medically approved” family planning methods. In contrast to the current requirement, it would allow for exclusion of contraceptive methods based on grantee bias, limiting methods provided. Another is the provision of funds to faith-based entities that promote fertility awareness and abstinence. The rule change would open the door for ideologically-driven entities that oppose abortion and most forms of contraception-for example, so called “crisis pregnancy centers”-to become Title X grantees, offering medically inaccurate information and a single form of contraception, i.e., natural family planning. The rule elevates natural family planning and abstinence counseling to a program priority and excludes reference to evidence-based contraception guidelines.

The rule creates burdensome requirements intended to block federal funds to Planned Parenthood. It requires Title X grantees to create additional financial and physical separation of contraception and abortion services. The rule targets centers that provide both Title X family planning services and non-federally funded abortion services, forcing clinics to stop providing abortion care or to shutter their Title X family planning component. In a similar change, when Texas excluded abortion providers from its family planning program in 2013, the number of contraceptive prescriptions, provision of LARC and number of women served by the program dropped dramatically. 

The rule restricts non-directive pregnancy options counseling and abortion referral: The most explicit anti-abortion components of the rule egregiously violate the patient-provider relationship and limit access to reproductive health care. Title X providers could not encourage, promote or “present” the option of abortion unless the patient had already chosen to terminate the pregnancy and explicitly requested a referral. In that case, a physician may, but is not required, to give her a list of providers, all of whom must offer prenatal care but only some of whom may also provide abortion. The physician may not tell the patient which providers on the list provide both abortion and prenatal care, even if she explicitly asks. If the patient has not made up her mind but requests information regarding abortion referral, the provider may only give her a list of providers who offer prenatal care. This “gag” component violates providers’ ethical duty to impart complete, unbiased, and accurate information and is counter to the quality-care principles of the Institute of Medicine.

The rule undermines adolescents’ confidentiality: Under current rules, Title X providers must offer confidential services to adolescents. The proposed rule requires providers to certify that they encourage family participation in minors’ decisions to seek family-planning services, including required documentation of specific actions taken to encourage family involvement. Because this requirement would undoubtedly deter many minors from seeking care, it runs counter to our national goal of reducing the high rate of teen pregnancy and sexually transmitted infections.

In addition, the dense 31-page document outlining the proposed rule contains vague and confusing language. Struggling to understand what is and is not permissible, providers are apt to err on the side of a more conservative interpretation, lest they inadvertently violate the rule. If authorized, this rule would make effective birth control far less accessible to low income women-including women of color-and would therefore exacerbate the socioeconomic and racial health inequities tarnishing American society. 

Title X has had an enormous positive impact on women’s health. Twenty percent of women in the United States who receive contraceptive services obtain them from a Title X-supported clinic. Consequently, in the past two decades Title X has averted nearly 20 million unintended pregnancies and 9 million abortions. The program has saved three tax-payer dollars for every dollar invested.

The Centers for Disease Control and Prevention heralded family planning as one of the top 10 public health achievements of the 20

century. Family planning has led to improved health outcomes for infants, children, and adult women and has provided new social and economic opportunities for women.

The comment period for the rule changes ended on July 31, 2018. The American College of Obstetricians and Gynecologists, along with 40 of its state Sections-including New Mexico ACOG-submitted formal comments to the Department of Health and Human Services detailing all these concerns on behalf of women’s health care providers. Many other leading medical organizations also lent their expertise to oppose the rule, and we’re hopeful the Administration will take heed. In the meantime, while we wait to hear the decision on final rule language, as ob/gyns, we must take our place in the vanguard, continuing to honor our human-rights charge of empowering women, families and societies through access to family planning.

Disclaimer: This guest editorial does not necessarily reflect the views of all members of the editorial staff or the board of 

1. Compliance with Statutory Program Integrity Requirements, 83 Fed. Reg. 25502 (June 1, 2018) (to be codified at 42 CFR Part 59).  Accessed at 

https://www.gpo.gov/fdsys/pkg/FR-2018-06-01/pdf/2018-11673.pdf

2. The Title X Family Planning Program in New Mexico.  National Family Planning and Reproductive Health Foundation.  Accessed 8-19-18 at 

https://www.nationalfamilyplanning.org/file/impact-maps-2017/NM.pdf

3. Mia R. Zolna & Jennifer J. Frost, Guttmacher Inst., 

Publicly Funded Family Planning Clinics in 2015: Patterns and Trends in Service Delivery Practices and Protocols

 at 30, 35 (2016).  Accessed 8-19-18 at 

4. Gavin L, Moskosky S, Carter M, et al.  Providing Qualify Family Planning Services: Recommendations of CDC and the U.S. Office of Population Affairs, MMWR 2014;63(4)1-54.  Accessed 8-19-18 at 

5. Title X: Three Decades of Accomplishment. The Guttmacher Report on Public Policy (2001). Accessed 8-19-18 at 

6. CDC:  Achievements in Public Health, 1900-1999:  Family Planning  

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4847a1.htm

Proposed changes to the regulations threaten the preventive health care benefits for women and families that the program was originally created to provide.

Don’t mess with Title X,  vital for women’s health

Historical perspective on septic abortion

The article “Sepsis and Septic Shock in Pregnancy” in the June 2018 issue was informative. I thought you would be interested, at least for historical perspective, in the experience at Los Angeles County-USC Medical Center in the 1950-1960 era. At that time septic abortion was by far the most common and severe form of pregnancy infection, especially with complications of generalized sepsis, septicemia, endotoxin shock, renal shutdown (acute cortical necrosis) and vascular collapse.

Until our protocols were developed, at least one fatality per month occurred at that facility. Most of the techniques were employed as described in the contemporary article, including diagnosis-usually very easy-then vascular support, very aggressive antibiotics, antitoxin and steroids, removal of infected tissue (early) and “peritoneal dialysis.”

 from the Green Journal from LA County-USC Medical Center by the late and great Gail Anderson, first full-time chief of OBGYN at LA County-USC Medical Center and me, on a special subset caused by clostridium welchii organism. Early removal of infected tissue by hysterectomy, peritoneal dialysis, antitoxin along with antibiotics all were necessary to lower the incidence of morbidity and mortality.

Another paper referenced in this article described the more “usual” septic abortion (E. coli, etc). Of course, since Roe v Wade these medical problems are much reduced, although principles of diagnosis, treatment, etc. described in your article are very beneficial.

The clash between “right to choose” and “right to life” has powerful arguments on both sides. Perhaps more effective, cheaper and safer contraception will help solve the medical, economic, and moral dilemmas on both sides.

Thank you for sharing your historical perspective with our readership regarding septic abortion. I would like to take this opportunity to acknowledge the significant clinical contributions to women’s health care made by providers like you who work so diligently in the trenches.

Dr. Lance Lang, the Chief Medical Officer of Covered California (a California health care exchange), has said “time’s up” regarding cesarean delivery rates. By 2019, hospitals whose rates do not meet the ACA Exchange’s average cesarean rate will be kicked out of their network. But the ethical question for physicians and society alike is, is this even moral? 

I have been an ob/gyn for most of four decades and my approach to obstetrics has not changed. Some years, my cesarean delivery rate was very low, and in others I was an “outlier” on the high side. 

Women must be treated as individuals. Although the industrial revolution increased quality and decreased costs in manufacturing, I do not believe that we can or should apply those principles to our patients. Women are not widgets.

In the Oath of Maimonides, we are called upon to vow and say, “May the love for my art actuate me at all time; may neither avarice nor miserliness …engage my mind.”  Yet government regulators, insurance companies, the Leap Frog organization, Dr. Ezekiel Emanuel and Dr. Lang appear to have lost their memory of this oath. In Ancient Greece, Hippocrates said, “Whatsoever house I may enter, my visit shall be for the convenience and advantage of the patient.” In 1964, Louis Lasagna, the Academic Dean of the School of Medicine at Tufts University, created the modern version of the Hippocratic Oath that most schools use today. In it, we swear to “apply, for the benefit of the sick, all measures which are required ... ” - to the benefit of the sick, not to the benefit of government, the federal budget, an ACO or the Covered California ACA Exchange.

Dr. Charles Lockwood’s discussion on the “

 and Dr. Allan Jacobs’s “Is There a Happy Medium?”

 articulate how physicians have lost their ability and autonomy to individualize care in their patients’ best interests.

I will always defend best practices as well as the rights of women to have full and truly unbiased informed consent. I will not compromise either my primary responsibility to my individual patients nor my commitment to adhere to the oaths of Maimonides and Hippocrates, and I would advocate that every physician try to understand that perspective when analyzing data on physicians who appear to be outliers.

I recognize the goals of the government and insurance companies, but as someone who had zero NTSV (Nulliparous, Term, Singleton, Vertex ) cesareans for many quarters, I would caution administrators about over-analyzing low-volume physicians like me or hospitals whose demographics differ from the “average.” The statistical swings caused by several patients in any one quarter are truly meaningless. For many years, my cesarean rate was one of the lowest at Cedars-Sinai Medical Center and as noted above, I have not changed my practice style or my patient demographics; other years I was an “outlier” on the high side.

Clearly the informed consent of a 42-year-old who had 

 fertilization, has a floating vertex presentation with a low Bishop score, and an estimated fetal weight of 4000 g at 40 6/7 weeks must include the risks of primary cesarean but also the risks of a long labor that ends up in a cesarean, the occasional risk of shoulder dystocia or third- or fourth-degree extension. Not having had a shoulder dystocia or third/fourth degree in over a decade clearly justifies my rationale.

Approximately 20 years ago I was “politely” criticized by our then-department chairman for doing serial scalp testing (with good pHs) in the second stage of labor on a primipara. FHTs had deep severe variables with a stable baseline and moderate variability. Once safely deliverable, I placed low forceps and shortened the second stage-cord gases were normal: 7.21/7.23. His argument was that even though I was following the “book,” 1% of the time scalp testing will be falsely negative (saying normal pH when in fact there was acidosis) and that the institution would prefer to have us do a cesarean to avoid litigation. In today’s climate, hospital leadership would prefer the vaginal delivery, lowering their insurance company and government-monitored NTSV cesarean rate. Have women changed in 20 years? Why, then, has the practice of obstetrics?

Brilliant economists like Peter Orzag and Jonathan Gruber recognized that only with consolidation as well as salaried physicians and nurse extenders working under strict centrally planned protocols could costs be contained. Yet these men are not at our patients’ bedsides at 3:00 AM delivering babies. Another lead architect of the ACA, Dr. Ezekial Emanuel, also has advocated making societal trade-offs favoring budget savings over individual health, especially concerning people over the age of 75 or those with a small chance of success from costly therapy. Health economists like him accept more stillbirths, babies with hypoxic ischemic encephalopathy, cerebral palsy or Erb’s palsy as long as it lowers governmental expenditures. Do the parents of these children get a vote? 

In my opinion, the overwhelming majority of practicing physicians, like me, feel more aligned with the oaths of Hippocrates and Maimonides. We believe that we have a moral, ethical and medical responsibility to the individual patient and not to an ACO or government bean counter.

I would suggest an overarching theme: Choice.

 Doesn’t our country, doesn’t our Constitution give us freedom to make our own intelligent decisions?  Are we not given the right to make reasonable choices different from what others would? Are we not free to make reasonable decisions even if government or their surrogates prefer that we don’t?

Don’t doctors have the right to make different decisions

 based on reasonable data and their own interpretation of medical literature?

 Imagine if there were only size 8 jeans in America. Some women couldn’t even fit in them and some would be swimming in them. So why does Washington or Covered California tell us there is only one way to practice obstetrics?

Lockwood CJ. Industrialization of medicine: coming soon to a practice like yours. 

, July 1, 2011:10. Available at: http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/modernmedicine/modern-medicine-now/industrialization-medicine-coming-soon-pr?page=full. Accessed Aug 17, 2015.

Contemporary OB/GYN readers react to some of our articles and share their perspective on issues facing the industry. 

Vol. 64 No. 09

Comparing policies on drug and alcohol use by pregnant women

Gottesfeld-Hohler Memorial Foundation sponsors 6th annual hands-on ultrasound course for residents

Electronic records and metadata: Old and new liability risks

How to minimize vaginal birth complications

Don’t mess with Title X, vital for women’s health

Readers React