New ACOG guidelines: Invasive prenatal testing should be offered to all pregnant women

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New

ACOG guidelines: Invasive prenatal testing should be offered to all pregnant

women

December 15th, 2007

From

Obstetrics

& Gynecology, Volume 110, No. 6, December 2007, page 1459 (ACOG

membership or $20 payment required for articles.)

Heralding a change in standard obstetric practice, the American College of

Obstetricians and Gynecologists has recommended that pregnant women of all ages

– not just women aged 35 and over — should be offered invasive

prenatal diagnostic testing such as amniocentesis and chorionic villus sampling

to detect possible genetic abnormalities in their fetuses.

The recommendation, published in a practice bulletin in the December issue

of the organization’s journal Obstetrics & Gynecology, dramatically

expands women’s access to prenatal diagnosis, effectively making all

prenatal tests and screens available to all of the 6 million American women who

get pregnant each year. It will establish a new standard of care, and change

expectations for insurance coverage and legal liability involving pregnancy.

Until now, obstetricians have usually offered invasive testing just to women

at or above age 35 at delivery. The age threshold was chosen because at that

age the risk of miscarriage as a result of the testing was roughly equal to the

risk of having a child with Down syndrome, the most common genetic abnormality

occurring in live births. In addition, the medical community balanced the cost

of offering the testing against their calculation of the cost savings

associated with preventing the birth of an infant with Down syndrome.

This past January, ACOG expanded the scope of prenatal testing by

recommending for the first time that all pregnant women regardless of age be

offered prenatal screening, a process in which a woman’s blood is used to

calculate the risk that her fetus has an abnormality.

The December ACOG bulletin will open prenatal testing access wider still.

The current bulletin does not explain why the professional organization has now

dramatically expanded access to prenatal testing twice within a year.

Researchers have maintained that universal access to prenatal testing will

allow women to make their own informed decisions regarding their pregnancies

and minimize disparities in access to health care.

The changes come at a time when growing numbers of medical malpractice

lawsuits are pushing insurance costs for obstetricians and gynecologists to

record highs, resulting in a situation that ACOG has called a “medical

liability crisis.”

In a statement posted on the group’s website last year, ACOG executive

vice president Ralph W. Hale said the rising tide of lawsuits was caused not by

a high rate of medical wrongdoing but by unreasonable public expectations.

“Ob-gyns are vulnerable because they practice in a high-risk field, and

all too often, doctors are held liable for less than perfect outcomes,”

he said.

ACOG’s current recommendation seems to thrust the 49,000-member

professional organization deeper into the cultural debate over public attitudes

toward abortion, particularly about where to draw the line between preventing

disability and accepting human diversity.

The National Down

Syndrome Congress (NDSC) last January condemned ACOG’s recommendation

for universally offered prenatal screening, saying it conveyed “tacit

approval for terminating pregnancies where the fetus has Down syndrome.”

Studies say that approximately 9 out of 10 pregnancies in the U.S. in which

Down syndrome is diagnosed end in abortion.

The NDSC also cited research noting that many doctors are not adequately

prepared to deliver a diagnosis of Down syndrome, and often use negative

language and out-of-date information.

Down syndrome, which results when a person has three copies of the 21st

chromosome instead of the usual pair, is longest known and most common genetic

birth defect, as well as the most common cause of intellectual disability.

Approximately 250,000-350,000 Americans have Down syndrome, which occurs once

in every 733 to 1,000 births, according to the NDSC and the National Down Syndrome Society.

Advocacy groups and parents say gains in health care and education have

brought about markedly improved outcomes for these individuals over the past

two decades, with many people with Down syndrome now completing high school,

holding jobs and living semi-independently. But parents say these gains have

not been adequately documented and are poorly understood within the obstetrics

community.

In an apparent nod to the NDSC’s criticism, ACOG included in its

December practice bulletin for the first time the recommendation that

prospective parents who receive a diagnosis of a fetal disorder should be

provided with “detailed information, if known, about the natural history

of individuals” with the disorder.

ACOG also noted that “it may be very helpful” to refer

prospective parents to advocacy groups such as the NDSC or the NDSS.

The bulletin does not, however, offer any recommendations for collecting or

distributing information to doctors about the lives of people with Down

syndrome or other chromosomal abnormalities, nor for training its 49,000

members in delivering and interpreting prenatal test information. A study

published in ACOG’s journal last year found that 45 percent of

obstetricians rated their training about prenatal testing as “barely

adequate or nonexistent.”

As a result of the new ACOG bulletin, each pregnant woman will now need to

decide which is greater: her fear of a chromosomal abnormality, or her fear

that invasive testing could harm her fetus. The ACOG bulletin estimates that

the risk of miscarriage as a result of the invasive tests is “as low

as” one in 300-500, and “may be even lower with experienced

individuals or centers.” Other estimates say that approximately one in

every 200 women who undergoes invasive testing will miscarry her pregnancy.

The risk of a fetus with a chromosomal abnormality varies with the

mother’s age. According to ACOG data, the lowest recorded risk goes to

19-year-olds, with a risk of 1 in 555, and the highest goes to a 49-year-old,

with a risk of 1 in 6.

The financial impact of the new ACOG bulletin is not known, but could extend

above the billion-dollar mark. Amniocentesis and chorionic villus sampling

(CVS), the invasive tests, are both more expensive and more accurate than the

maternal blood test screens. The consumer cost of each amniocentesis is more

than $1,000. Chorionic villus sampling costs between $600 and $1200. More

invasive tests would also call for an increase in costs for training,

facilities and equipment.

Amniocentesis and CVS each involve removing and examining material from

inside the uterus during pregnancy with a long needle or plastic tube to check

for chromosomal differences.

The maternal blood-test screens do not deliver definitive results but only

report the odds that a particular fetus may have an abnormality. They also

carry a significant risk of both false positives and false negatives.

In a tacit acknowledgment of the ongoing abortion debate, the bulletin notes

that “Prenatal diagnosis is not performed solely for assistance in the

decision of pregnancy termination. It can provide useful information for the

physician and the patient.”

The practice bulletin listed the recommendation for offering invasive

diagnostic testing to all pregnant women as a “Level C”

recommendation, one that is “based primarily on consensus and expert

opinion.” This is the lowest rank used in justifying ACOG

recommendations.

Higher rankings that may be used for ACOG recommendations are “Level

A” (”based on good and consistent scientific evidence”) and

“Level B” (”based on limited or inconsistent scientific

evidence.”)

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Saturday, December 15th, 2007 at 4:55 am and is filed under Down syndrome