So many chickens!

At what point do we worry that the sky is falling? At what point is the sky falling? The fear and the actuality can be connected with a line as thin as an EFM trace.

Continuous electronic fetal monitoring (EFM) was introduced to American maternity care in 1970 with the untested promise that it would reduce the incidence of cerebral palsy (CP) by half. CP is a collection of conditions said to be caused by fetal oxygen deprivation during labor and birth. For over 30 years, the scientific community has recognized that EFM has failed to deliver on its promise. Worse than that failure, however, is EFM’s track record of causing an increase in medical interventions, most notably cesarean surgery, which in turn is responsible for increased morbidity and mortality.

Yet EFM is still used in most U.S. births. Furthermore, EFM is so entrenched in hospital practice that true informed consent for its use is rarely given; indeed, patients find themselves almost completely unable to refuse continuous monitoring. How did we get to this place where the standard of care is endangering good care?

CIRCUMSTANCE	RESULT
EFM was put into use six years before the passage of the Medical Device Amendments Act of 1976 that authorized the Food and Drug Administration to begin regulating medical devices.	EFM use was institutionalized with minimal oversight. The lack of regulation allowed EFM manufacturers to grow to an over $2 billion industry.
EFM enables nursing staff to track multiple patients from a central bank of monitors, thereby cutting down on staffing that would be required to monitor patients in person. The electronic feed can also be shared with offsite physicians, allowing them to maintain a private practice and carry out other obligations while still caring for their hospital patients.	Staff attention is divided between multiple patients. Patients therefore receive less hands-on attention, allowing abnormalities that may not trigger an abnormal EFM trace to be missed or ignored by providers. Physician interactions with their patients become even more sporadic, sometimes absent until the baby is crowning.
Providers view EFM not as an individual procedure with attendant risks and benefits, but as a part of the standard Labor and Delivery package, for which the patient has signed a blanket consent form upon admission.	Patients are not given an opportunity to receive informed consent about EFM use. Since they don’t explicitly consent to EFM, there is no formal opportunity to refuse it. When patients do try to refuse EFM, providers feel tremendous institutional pressure to insist on its use.
It was anticipated that EFM would protect practitioners and institutions from medical malpractice liability. The presence of a physical strip (or, nowadays, an electronic file) containing a record of the entire labor, would surely show where physicians acted appropriately. Plaintiff’s attorneys could likewise rely on the strip to show where defendants acted negligently. Unfortunately, the interpretation of EFM signals is notoriously unreliable and variable.	In medmal cases, the EFM strip is now used by both Plaintiff and Defense, with the result that failing to produce a strip in one’s defense is taken as an admission of negligence. Hospital Risk Management departments insist on the use of EFM for potential use in litigation. EFM’s 99% false positive rate remains unacknowledged in courts of law, where dueling experts defend their variable interpretations of the strip.
EFM was a new technology that promised to help transcend the barrier of the maternal body, allowing physicians to see more closely what was happening within.	Physicians have come to depend on EFM, not only because of the predictable technological imperative, but also because hand skills, such as abdominal palpation, are no longer taught.
The American College of Obstetricians and Gynecologists (ACOG), in its latest practice bulletin on fetal monitoring (#106, 2009), acknowledges all the shortcomings of continuous EFM, including its greater than 99% false positive rate for predicting cerebral palsy and its association with increased instrumental deliveries (forceps and cesarean surgery). Nevertheless, its practice bulletin concludes, “Given that the available data do not show a clear benefit for the use of EFM over intermittent auscultation, either option is acceptable in a patient without complications.” In its latest Committee Opinion (#766, 2019) on “Approaches to Limit Intervention During Labor and Birth” (Committee Opinion #766, 2019), ACOG does not actively recommend replacing EFM, but instead suggests providers  consider making arrangements for a hand-held Doppler “for low-­risk women who desire such monitoring during labor.”	ACOG’s practice bulletins are subtitled “Clinical Management Guidelines for Obstetrician-Gynecologists.” During litigation, expert witnesses may, depending on specific state law, introduce these guidelines as evidence of standard of care. Because PB 106’s conclusion approves the use of EFM and neglects to note that intermittent auscultation shows a clear benefit over EFM, ACOG’s stance shores up the legal position of EFM use. The alternate recommendations in CO 766 would be more effective if they were issued in a bulletin that formally replaced PB 106. Since this is not the case, the PB 106 guidelines still stand.

The factors listed above have contributed to the current EFM impasse: everyone is aware of EFM’s essential defects, but all parties seem united in an emperor-new-clothes fiction that EFM is keeping birthing people and their babies safe. However, as mainstream maternity care begins to focus on reducing non-medically-indicated cesarean surgery in order to rein in the shocking U.S. rate of poor outcomes, most particularly maternal mortality, perhaps EFM will be recognized for its causative role in this situation. We can hope and advocate for appropriate steps that will overcome the barriers to replacing EFM with something more evidence-based, effective, and safe.

This cartoon and post are dedicated to Susan Jenkins, Esq., who created the formulation of risk explained in the final frame, and to Thomas Sartwelle, Esq., who has written extensively on the subject of EFM and was kind enough to share his wisdom at the Birth Rights Bar Association 2019 conference.

Bibliography

“ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth.” Obstetrics & Gynecology 133, no. 2 (February 2019): e164. https://doi.org/10.1097/AOG.0000000000003074.

“ACOG Practice Bulletin No. 106: Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Principles.” Obstetrics & Gynecology 114, no. 1 (July 2009): 192. https://doi.org/10.1097/AOG.0b013e3181aef106.

Berlatsky, Noah. “The Most Common Childbirth Practice in America Is Unnecessary and Dangerous.” Text. The New Republic, August 13, 2015. http://www.newrepublic.com/article/122532/most-common-childbirth-practice-us-unnecessary-dangerous.

Dekker, Rebecca, and Bertone, Anna. “The Evidence on: Fetal Monitoring.” Evidence Based Birth® (blog), May 21, 2018. https://evidencebasedbirth.com/fetal-monitoring/.

Lent, Margaret. “The Medical and Legal Risks of the Electronic Fetal Monitor.” Stanford Law Review 51 (1999): 33.

Nelson, Karin B., Thomas P. Sartwelle, and Dwight J. Rouse. “Electronic Fetal Monitoring, Cerebral Palsy, and Caesarean Section: Assumptions versus Evidence.” BMJ 355 (December 1, 2016): i6405. https://doi.org/10.1136/bmj.i6405.

Sartwelle, Thomas P., and James C. Johnston. “Cerebral Palsy Litigation: Change Course or Abandon Ship.” Journal of Child Neurology, September 2, 2014. https://doi.org/10.1177/0883073814543306.

———. “Neonatal Encephalopathy 2015: Opportunity Lost and Words Unspoken.” The Journal of Maternal-Fetal & Neonatal Medicine 29, no. 9 (May 2, 2016): 1372–75. https://doi.org/10.3109/14767058.2015.1051526.

Sartwelle, Thomas P. “Defending a Neurologic Birth Injury.” Journal of Legal Medicine 30, no. 2 (June 2, 2009): 181–247. https://doi.org/10.1080/01947640902936522.

———. “Electronic Fetal Monitoring: A Bridge Too Far.” Journal of Legal Medicine 33, no. 3 (July 1, 2012): 313–79. https://doi.org/10.1080/01947648.2012.714321.

———. “Electronic Fetal Monitoring: A Defense Lawyer’s View.” Reviews in Obstetrics and Gynecology 5, no. 3–4 (2012): e121–25.

Sartwelle, Thomas P., James C. Johnston, and Berna Arda. “A Half Century of Electronic Fetal Monitoring and Bioethics: Silence Speaks Louder than Words.” Maternal Health, Neonatology and Perinatology 3, no. 1 (December 2017). https://doi.org/10.1186/s40748-017-0060-2.

———. “The Ethics of Teaching Physicians Electronic Fetal Monitoring: And Now for the Rest of the Story.” The Surgery Journal 03, no. 1 (January 2017): e42–47. https://doi.org/10.1055/s-0037-1599229.

Sartwelle, Thomas P., James C. Johnston, Berna Arda, and Mehila Zebenigus. “Cerebral Palsy, Cesarean Sections, and Electronic Fetal Monitoring: All the Light We Cannot See.” Clinical Ethics, May 24, 2019, 147775091985105. https://doi.org/10.1177/1477750919851055.

Wickham, Sara. “The Case against Electronic Fetal Monitoring | Sarawickham.” Sara Wickham: Midwife, Author, Speaker, Researcher (blog), September 8, 2014. http://www.sarawickham.com/research-updates/the-case-against-electronic-fetal-monitoring/.

Image credits

All images are shared under a Creative Commons license, unless otherwise noted. Where required by license, changes to the image are noted.

• Frame 1. Photo of chickens on a fence is by wilmapolinder.
• Frame 2. Photo of chicken is by By_Jo. Photo of parents-to-be is by Andre Adjahoe. Photo of the fetal monitor is by HombreDHojalata. Photo of hospital room is by Martha Dominguez de Gouveia. Image of the Corinthian column is by an unknown author, scanned by sidonius.
• Frame 3. Photo of the hospital corridor is by W.carter. The conferring chickens are from a photo by Alexas_Fotos.
• Frame 4. Photo of the hospital corridor is by W.carter. The conversing chickens are by Alexas_Fotos.
• Frame 5. The hospital atrium photo by Nadia Eimandoust was cropped, labeled with signage, given columns and a smoother background. The photo of clustering chickens is by Alexas_Fotos.
• Frame 6. The photo of the columned space is by zetafilm. The determined chicken is by ulleo. The statue of Augustus Caesar was photographed by Anna and Michael. The background was removed, as was a small figure that was clinging to his leg. Caesar’s stethoscope is from a photo by punggolzenith; his scalpel is by boobaloo.