Clinical Insights/Professional Update





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Choose article section... Don't blame cerebral palsy on labor and delivery Using a no-fault approach to solve the malpractice debacle An alternative approach to hysterectomy Quadruple test heightens prenatal detection of Down syndrome Clindamycin reduces rate of late miscarriage and preterm delivery Admission cardiotocography unjustified, study says ThinPrep Pap test offers best detection of cervical cancer PROFESSIONAL UPDATE US Supreme Court rules on HMOs Medical liability reform passed in House, faces challenges in Senate

Highlights from 2003 ACOG Annual Meeting

Don't blame cerebral palsy on labor and delivery

Less than 10% of cases of neurologic damage in newborns occur during labor and delivery, according to an exhaustive analysis of the scientific research just released at ACOG's annual clinical meeting. Neonatal Encephalopathy and Cerebral Palsy: Defining the Pathogenesis and Pathophysiology explains that hypoxia during labor or delivery is not a major cause of brain injuries and that fewer than 25% of infants with NE or CP have been found to have had an insufficient oxygen supply. The majority of cases of NE and CP, the report concludes, result from developmental or metabolic abnormalities, autoimmune and coagulation defects, trauma, or a combination of these factors.

Among the risk factors that predispose women to NE and CP are a family history of seizures or neurologic disorders, infertility treatments, placental or uterine rupture, maternal thyroid disease, severe preeclampsia, and intrauterine growth restriction.

The ACOG task force also established criteria that should be met in order to pinpoint those cases of neurologic injury that are likely to be labor-related. Among the criteria to define "an acute intrapartum hypoxic event as sufficient to cause cerebral palsy" are four features—all of which must be present:

  • evidence of metabolic acidosis in umbilical cord arterial blood obtained at delivery;

  • early onset of severe or moderate NE in infants born at 34 weeks or later;

  • the presence of spastic quadriplegic or dyskinetic CP;

  • the exclusion of other causes including trauma, coagulation disorders, infection, and genetic defects.

Using a no-fault approach to solve the malpractice debacle

An "Early Offers" reform plan outlined by a prominent law professor may help defuse the professional liability crisis now facing ob/gyns. Presenting his "no fault" approach at the 2003 ACOG annual meeting, Jeffrey O'Connell, JD, suggested that physicians could agree to offer to pay a plaintiff's net economic losses within 120 days of a medical maloccurence claim. Once the physician agreed to make these payments, patients would no longer be allowed to pursue a tort claim for pain and suffering or other noneconomical losses. Under the proposal, plaintiffs would have the right to reject the offer, but only if they could establish beyond a reasonable doubt that the injurious act was the result of intentional or wanton misconduct.

Mr. O'Connell, the so-called "father of no-fault insurance" and a professor at the University of Virginia, added that under this plan, if an early offer were accepted by a patient, the clinician would then be free to candidly discuss all the details of the adverse events without threat of impending litigation.

An alternative approach to hysterectomy

A new bloodless, nerve-sparing approach to abdominal hysterectomy garnered considerable attention at the 2003 Scientific Sessions. According to a poster presented by clinicians at Fountain Valley (Calif.) Regional Hospital and Medical Center, the intrastromal procedure does not disturb the pelvic support system, generates less blood loss, and allows patients to leave the hospital sooner.

Comparing the new approach to traditional hysterectomy, investigators found a significantly smaller drop in hemoglobin levels (1.0 vs. 1.4 g/dL, P= 0.001) and 2.7 days versus 3.15 days in the hospital. The new procedure also caused no ureter injuries, vaginal vault prolapse, posthysterectomy fistulas, or infections.

Quadruple test heightens prenatal detection of Down syndrome

The quadruple test—which calculates the risk of Down syndrome from maternal age and the concentrations of maternal serum-alphafetoprotein, unconjugated estriol, human chorionic gonadotropin, and inhibin-A—performed between 14 and 22 weeks' gestation offers the best odds of accurately diagnosing fetal Down syndrome, according to two separate studies.

The first study from England involving over 46,000 pregnancies from 14 hospitals calculated a detection rate and false-positive rate for the quadruple test of 81% and 7%, respectively, compared to 51% and 14%, respectively, for maternal age alone. The quadruple test also outperformed the double test (detection rate 61%) and the triple test (detection rate 66%).

The second study of almost 24,000 pregnancies calculated the sensitivity of the quadruple test to be 85.8% with a false-positive rate of 8.2%. Positive predictive value was 1 in 51. Not only is the quadruple test economically justifiable in its own right, the authors noted, it also provides the indirect benefit of more effective utilization of amniocentesis.

Wald NJ, Huttly WJ, Hackshaw AK. Antenatal screening for Down's syndrome with the quadruple test. Lancet. 2003;361:835-836 and Benn PA, Fang M, Egan JF, et al. Incorporation of inhibin-A in second-trimester screening for Down syndrome. Obstet Gynecol. 2003;101:451-454.

Clindamycin reduces rate of late miscarriage and preterm delivery

Treating asymptomatic abnormal vaginal flora and bacterial vaginosis (BV) with oral clindamycin early in the second trimester of pregnancy reduces the number of preterm deliveries and miscarriages by about two thirds, according to a recent randomized, controlled trial.

Researchers studied over 6,000 women and found that clindamycin reduced adverse outcomes across the range of abnormal Nugent scores, with women with the highest Nugent score of 10 benefiting the most. They calculated that 10 women with abnormal intermediate flora or BV needed to be treated to prevent one late miscarriage or preterm birth.

Unlike previous studies with metronidazole, which showed no benefit from treatment, 76% of this study population received either drug or placebo by 17 weeks' gestation, as opposed to 24 weeks in the other studies. The authors of this latest research point out that while the optimum time to screen and treat is still unknown, it may be even earlier in pregnancy or during prepregnancy.

Ugwumadu A, Manyonda I, Reid F, et al. Effect of early oral clindamycin on late miscarriage and preterm delivery in asymptomatic women with abnormal vaginal flora and bacterial vaginosis: a randomised controlled trial. Lancet. 2003;361:983-988.

Admission cardiotocography unjustified, study says

Routine use of electronic fetal monitoring (EFM) for 20 minutes upon admission to the delivery ward in women at low risk of fetal distress during labor does not improve neonatal outcomes or reduce rates of caesarean section, instrumental delivery, or episiotomy, according to a randomized, controlled British trial.

It was thought that the procedure might function as a fetal stress test, identifying those who might become hypoxic during labor and those who were already hypoxic and in need of prompt delivery.

But when researchers randomly assigned 8,580 women admitted to the delivery ward of a Dublin hospital to receive either admission EFM or intermittent auscultation of fetal heart rate with continuous EFM only if indicated, they found that reactive admission cardiotocograms didn't prevent any adverse neonatal outcome and had only modest predictive value for soft outcomes, such as mild asphyxia and fetal distress.

Impey L, Reynolds M, MacQuillan K, et al. Admission cardiotocography: a randomised controlled trial. Lancet. 2003;361:465-470.

ThinPrep Pap test offers best detection of cervical cancer

The ThinPrep Pap test increases detection of high-grade squamous intraepithelial lesions (HSIL) by 233% over conventional Papanicolaou smear, according to the latest and largest head-to-head study, which looked at over 2.1 million samples.

It also increases detection of low-grade lesions, when compared to conventional Paps, by more than 100% and yields significantly fewer false-negative results for both types of lesions.

Accumulating evidence seems to indicate that the conventional Pap test, with an overall sensitivity of little more than 50%, is past its prime. Liquid-based testing increases the detection rate to about 93%. And an editorial accompanying the research study points out that adding testing for HPV DNA to the ThinPrep further increases sensitivity to nearly 100%.

Limaye A, Connor AJ, Huang X, Luff R. Comparative analysis of conventional Papanicolaou tests and a fluid-based thin-layer method. Arch Pathol Lab Med. 2003;127:200-204, and Austin RM. The detection of precancerous cervical lesions can be significantly increased: who cares and who should know? (Editorial). Arch Pathol Lab Med. 2003;127:143-145.


US Supreme Court rules on HMOs

Health maintenance organizations in states with "any willing provider laws" must open their networks to any health-care provider who agrees to abide by the plan's contract terms, the US Supreme Court ruled earlier this year. The ruling, which upheld Kentucky's any willing provider law, was unanimous.

According to Modern Healthcare (4/7/03), about 25 states have any willing provider laws, which require insurers to accept all out-of-network providers who wish to join under the insurers' contract terms. The high court decision could prompt other states to adopt similar legislation.

The decision was seen as a blow to the managed-care industry. Insurers claim that the ruling will result in higher costs, which will ultimately be passed down to the patient. HMOs have traditionally been able to keep costs down by assuring network providers that their direct competitors will be excluded—a tactic which guaranteed network providers a steady stream of patients and allowed HMOs to negotiate lower reimbursement rates.

Providers and state regulators, in contrast, praised the high court's decision. Modern Healthcare cited leaders of some medical and hospital groups on the state and national level who believe that the decision supports states' efforts to enforce HMO accountability and patient access to care.

Medical liability reform passed in House, faces challenges in Senate

Responding to the complaints by physicians and other groups about skyrocketing malpractice insurance premiums caused by frivolous lawsuits, the U.S. House of Representatives passed tort reform in the form of the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003 by a vote of 229-196. Now, with the ball in the Senate's court, it seems that the bill in its present form will face some challenges.

According to American Medical News (4/7/03), the HEALTH Act, or HR 5, as passed by the House would:

  • place a $250,000 cap on noneconomic damages such as pain and suffering;

  • limit punitive damages to double the economic damages or $250,000, whichever is greater;

  • hold physicians responsible for only their portion of damages;

  • establish a 3-year statute of limitations on most malpractice cases, with specific exemptions.

While Republicans and others praised the passage of the bill by the House, Democrats in the Senate have been critical of it—thereby suggesting that any medical liability reform bill that comes out of the Senate will be different from the House bill.

According to various news accounts, Senate Democrats oppose the $250,000 cap on noneconomic damages, preferring to remove the cap or increase it. The Democrats also favor tighter regulation over insurance companies as a means of getting premiums under control.

A compromise bill is in the works in the Senate. AMNews reported that the Senate compromise bill would increase the cap on most noneconomic damages to $500,000 and, in cases of severe disfigurement or death, allow awards up to $2 million or $50,000 multiplied by the number of years the patient is expected to live.


Clinical Insights/Professional Update.

Contemporary Ob/Gyn

Jun. 2, 2003;48:15-20.

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