Mayday, Mayday, Mayday! A Call to all Americans to fix a problem that is wasting millions of healthcare dollars & results in preventable maternal deaths

by faithgibson on May 1, 2019

in Contemporary Childbirth Politics

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1600 words

Chapter 1

A call to all Americans:

We need to fix a simple problem that wastes many millions of healthcare dollars every year on a ineffective technology that is very expensive and results in preventable maternal deaths and other needless tragedies for childbearing women and their families.

There is an ethical contradiction inherent in the current practice of obstetrics in the United States, a unique ethical dilemma that effects all Americans. It is a problem that concerns all of us, even if we, or one of our own family members, is not expecting a baby any time soon.

What we are & what are NOT saying

This plea for common sense is not an indiscriminate rant about the obstetrical profession. No one, least of all me as a former labor and delivery room nurse for 15 years, is questioning the life-saving ability of modern obstetric medicine for women with high-risk pregnancies or those who develop serious complications during labor.

In fact, we all are uniformly grateful that skilled obstetricians and high-tech obstetrical services are readily available to those lives depend on such swift interventions.

But currently, the noble humanitarian goals of obstetrics are not being realized for the healthy 70 to 85% of the childbearing population. This is not an inconsequential issue, either in the number of families affected, its expense in scarce healthcare dollars, and it’s impact on lives.

The routine use of Continuous Electronic Fetal Monitoring on
healthy, low-risk women does not prevent Cerebral Palsy or
similar neurological problems in newborns

laboring woman lying in bed while her unborn baby is being continuously monitored by EFIn the United States, healthy low-risk laboring women are being routinely subjected to a form of obstetrical care  — the use of continuous electronic fetal monitoring — that does not improve the outcomes for themselves or their babies when compared to the traditional method of periodically monitoring the well-being of a fetus with either a special stethoscope or hand-held Doppler and that low-tech, highly personal method was as good as an electronic machine, with the added benefits NOT increasing the C-section rate.

This non-continuous method is called periodic or intermittent auscultation (IA) and is the standard that c-EFM is compared to and measured against. When reading studies that found no benefit to c-EFM, this must be remembered.

The word ‘auscultation’ often not appear in the same sentence as the study or research paper’s conclusion, but studies on the efficacy of electronic monitoring contrasted the outcomes of c-EFM with those of intermittent auscultation.

Auscultation: the Science-based Standard for Healthy Women with low-risk pregnancies

Auscultation with a DeLee fetoscope

Based on the scientific evidence, IA is the preferred standard of care during the active stages of labor for women with normal pregnancies. IA is already is a routine part of the care provided by midwives and some family physician birth attendants.

Using a fetoscope or hand-held Doppler, the L&D nurse or other professional birth attendant regularly listens to the fetal heart every 30, 15 or 5 minutes, a frequency that depends on the stage of labor and baby’s response to long and strong contractions. By counting the heart rate for one full minute (or longer, but never shorter), the ‘beats per minute’ heart rate (bpm) and its rhythm (regular or not) are identified and recorded on the mother’s labor chart.

Auscultation uses the same four parameters of information for determining fetal well-being first taught by Dr. Joseph DeLee in the 1920s and still used for c-EFM when interpreting monitor strips. These include the normalcy of the rate and rhythm of the fetal pulse to identify a ‘reassuring’ pattern. This includes the presence of a:

    • normal baseline
    • normal variability
    • normal accelerations
    • no pathological decelerations

C-EFM: The Crux of the Obstetrical Profession’s Ethical Dilemma

The crux of the ethical contradiction I referred to earlier is obstetrical profession’s practice of using an expensive technology designed to help the unborn babies of women with high risk pregnancies and apply this technology universally to women who are low-risk. While there are many healthy and safety aspect of this ethical dilemma, one the most important to society is an economic issue known “value added”.

Relative to the price paid for goods or services, the idea of ‘value-added’ describes positive contributions that are suppose to make something substantially BETTER that it would be without that particular set of good or services and definitely NOT to make it worse!

The logical conclusion is end all obstetrical protocols in American hospitals that make the universal use of c-EFM the standard of care for all laboring women, including the 70-80% of healthy women with normal, low-risk pregnancies. In the place of this ineffective and in many circumstances, harmful policy is to introduce a new standard that calls for two major chances.

First, all healthy women with normal pregnancies need to be fully informed about the ineffectiveness of c-EFM when used on a low-risk population and the clear and present danger associated with the routine use of c-EFM due to the increase in Cesarean surgeries and associated complications and maternal mortalities.

Here is an sample of this clear language published professional journal in 2011

“Despite the widespread use of EFM, there has been no decrease in cerebral palsy.

… meta-analysis of randomized control trials has shown that EFM has no effect in perinatal mortality or pediatric neurologic morbidity.2

However, EFM is associated with an increase in the rate of operative vaginal and cesarean deliveries.1”

Although intermittent fetal auscultation {IA} may be a theoretical option in low-risk patients, nursing staffing limitations makes this impractical … ”

Fetal Heart Rate Monitoring Update; The Female Patient, April 2011

Secondly, full information must be provided to healthy childbearing women that identifies the routine use of auscultation as the appropriate standard of care for healthy women with normal low-risk pregnancies. Protocols for auscultation require one-on-one as provided by a L&D nurse or midwife throughout all active stages of labor.

The R2D2 of electronic fetal monitoring

The Big Blue Elephant in the Room: Hospital economics of c-EFM and the unproductive expense billed to health insurance carries and federal Medicaid program

The question here is whether state, county and federal governments, other 3rd party payers (insurance companies) and those who must pay out-of-pocket are getting an appropriate ‘bang for their buck’. Is the current configuration of a technology-centric form of obstetrical care, with management style doesn’t distinguish between high-risk and low-risk, making the kind of cost-effective contribution that economists refer to as ‘value added’?  

Based on a consensus of the scientific literature over the last 5 decades, the answer is a resounding “no”.

A healthy laboring woman two c-EFM belts wrapped around her pregnant belly that lead to the EFM machine at the bedside, an automatic blood pressure cuff hooked to a different monitoring machine and a pulse oximetry device on the index finer of her left hand.

This drift away from obstetrical care as a value-added services for women with high-risk conditions began in the mid-1970s. That’s when the obstetrical policies and practices that were so effective when used on women with high-risk pregnancies gradually become the new standard of care for healthy women with normal low-risk pregnancies.

Even more disturbing is the unambiguous cause-and-effect relationship btw the use of continuous EFM and a statistically significant increase in the rate of unplanned Cesarean surgeries and its many complications. [1, 2]

During the 5 decades-plus between 1970 and 2016, the Cesarean rate in the U.S. increased from 5% to 32%. During this same period, the use of c-EFM when from zero to 90%. In the U.S, the 2nd most common reason for first-time Cesareans is “non-reassuring fetal heart tones” (ACOG 2017, #184)

It must be noted that the adoption of c-EFM, which began as a gradual trend, was turned into a avalanche by the malpractice crisis of 1970s.

Plain Facts, Plain Talk

The facts are indisputable:  Our current obstetrical system treats all healthy women with normal pregnancies as if they were high-risk without improving perinatal outcomes, while continuing to increase maternal mortality and morbidity due to the many complications associated with surgical deliveries.

These facts are not a secret that the obstetrical profession doesn’t know anything about. There are literally hundreds of peer-reviewed professional papers  on the efficiency of continuous EFM published since 1975. An older but highly respected obstetrical textbook specifically charges obstetricians with a duty to keep up with the facts of their profession: 

“It is the duty of every obstetrician to know what can be known”
Davis Obstetrical Textbook, 1966

As for how many opportunities there are read the many studies on EFM, I personally stopped downloading URLs from my Google query (“clinical trials of electronic fetal monitoring”) after saving the links from 22 pages, with an average of 11 links per page or 242 studies and clinical trial on c-EFM.

In a variety of ways, many titles point out that assumptions by the obstetrical profession about the efficacy of the EFM don’t match the scientific evidence.

One example in which the title tells it all was a study entitled: “Electronic fetal monitoring, cerebral palsy, & caesarean section: assumptions versus evidence. BMJ. 2016;355:i6405.” 

Another paper written by an obstetrician for other obstetricians begins with this startling statistics:

“Intrapartum fetal heart rate monitoring is the most common obstetric procedure performed in the United States.

  • Despite the widespread use of EFM, there has been no decrease in cerebral palsy.
  • … meta-analysis of randomized control trials has shown that EFM has no effect in perinatal mortality or pediatric neurologic morbidity.2
  • However, EFM is associated with an increase in the rate of operative vaginal and cesarean deliveries.1”

Although intermittent fetal auscultation {IA} may be a theoretical option in low-risk patients, nursing staffing limitations makes this impractical … ”

{Fetal Heart Rate Monitoring Update; The Female Patient, April 2011}

Another study noted that only 0.2% (that’s only two out of a thousand) cases of cerebral palsy were able to be detected during labor by continuous EFM.

The response by EFM equipment manufactures to this sobering information has been to churn out various “improvements” on the existing crop of monitors, and amp up their R&D (Research & Development) for a host of new, but equally, or even more complicated monitoring devices.

Unfortunately, none of these 2nd, 3rd and 4th generation upgrades and add-on have been able to fix the central ‘problem’ — interventions that improve outcomes for very high-risk patients are reliable and predictable in making matters worse for healthy women with normal pregnancies.

We must always keep in mind that the science-based method for monitoring the well-being of a fetus during labor is to regularly listen to the fetal heart rate and rhythm with a fetoscope or hand-held Doppler.**

** Link to information of the principles, techniques and skills of auscultation

C-EFM, Product Liability Law & A Duty to Warn

We believe product liability law in the United States creates a Duty to Warn for all manufactures and distributors of continuous EFM equipment. This means that those who profit from the sales of continuous EFM equipment must include a product disclaimer

This manufacture’s disclaimer must report the established limitation of c-EFM documented in the many clinical trials and other studies conducted over the last 50 years on the efficacy of EFM as compared to auscultation. Furthermore, it must warn physicians and obstetrical providers that use of their product is associated with a statistically significant increase in operative deliveries and Cesarean surgery.

Again and again, studies and prospective clinical trials on the efficacy of c-EFM found no benefit for heathy women with normal pregnancies while establishing an unambiguous cause-and-effect relationship btw the use of continuous EFM and a statistically significant increase in the rate of unplanned Cesarean surgeries and its many complications. [1, 2]

Based on the preponderance of scientific evidence,  this “Duty to Warn” must include the following information:

  • As defined by a reduction in the rate of CP and other neonatal encephalopathies, studies that compared the routine use of periodic auscultation to c-EFM consistently determined that healthy laboring women with normal term pregnancies did NOT benefit from c-EFM
  • That the intrapartum use of c-EFM in this same category of low-risk women with normal pregnancies has been proven to experience a significant increase in unplanned Cesareans deliveries and associated complications
  • A list of the known complications of Cesarean surgery including the 13-fold increase in peri-partum emergency hysterectomies and 6% rate of secondary infertility;
  • Particular details must be provided about the type of abnormal placental implantation — placenta accreta, increta, and percreta — association with post-Cesarean pregnancies, and the 7% to 10% maternal mortality rate for women with a placenta percreta.

Continued ~ Day 2

How did things go so far in the wrong direction?

Before addressing that key question, it will be helpful to step back and look at the big picture from an historical perspective.

 

 

 

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