Management of pregnancy - VA/DoD Clinical Practice Guidelines ...

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VA/DoD Clinical Practice Guideline For Pregnancy Management at least two values of MSAFP exceeding 2.5 MOM, when corrected for gestational age, should be referred to advanced prenatal care follow-up. Down syndrome (trisomy 21) occurs in 1/800 births, increasing in risk with advancing maternal age. Eighty percent of babies with Down syndrome are born to women under 35 with no risk factors. Low MSAFP is associated with increased risk for Down syndrome (Haddow et al., 1992). If risk for Down syndrome is calculated solely on age versus AFP, detection increases from 25 to 37 percent. Pregnant women with fetuses affected by trisomy 21 tend to have lower than average levels of MSAFP and unconjugated estriol with elevated levels of serum HCG, when compared to women carrying euploid fetuses. Adding serum HCG and uncongugated estriol (“triple screen”) increases detection to 56 to 75 percent without increasing false positivity (Smith-Bindman et al., 2001). Triple screen also increases the antenatal detection rate for a variety of chromosome disorders, particularly sex chromosome abnormalities (Kellner et al., 1995). Ultrasound to assess fetal age is indicated for all women with low MSAFP or abnormal triple screen. It should be followed by amniocentesis for gestational age-adjusted persistent abnormal values. The benefit of increased detection of chromosome abnormalities should be weighed against the risk of fetal loss from amniocentesis. Edward’s Syndrome (trisomy 18) occurs in approximately one in 5,000 live births and is associated with a high rate of fetal death or early neonatal demise. Affected individuals surviving the neonatal period typically have profound neurodevelopmental delay and are unlikely to survive beyond five years of age. Pregnant women with fetuses affected by trisomy 18 tend to have lower than average levels of MSAFP, HCG, and unconjugated estriol. Approximately 50 percent of fetuses with trisomy 18 can be detected with maternal serum analyte screening and follow-up fetal karyotype analysis of screen-positive women. Customary practice is to offer amniocentesis or chorionic villus sampling to all women age 35 or older at the time of birth, and to women whose risk of Down syndrome by maternal serum analyte screening is equivalent to that of a 35-year-old woman. Data from randomized trials suggest the attributable risk of pregnancy loss due to amniocentesis is less than 1:1500 when performed by experienced clinicians. Accordingly, ACOG has recommended amniocentesis be available to women of all ages regardless of their a priori risk for carrying a fetus with aneuploidy (ACOG, 2007). For gravidas over 35, maternal serum analyte screening with subsequent confirmatory fetal karyotype analysis of screen-positive women identify up to 89 percent of fetuses with Down syndrome, with a false positive rate of 25 percent. For pregnant women over 35 who are willing to accept a potentially false-negative screen, the quad screen is a cost effective alternative to routine amniocentesis. This alternative practice could make more than 75 percent of amniocenteses unnecessary, thereby also reducing amniocentesis-associated fetal losses (Haddow et al., 1994). The complexity of the pre-screening and pre-testing counseling requires referral of high-risk women to a qualified healthcare provider for counseling. Any pregnant women determined to have a fetus with a serious structural abnormality or fetal aneuploidy should receive advanced prenatal care. EVIDENCE TABLE Recommendations Sources of Evidence LE QE SR 1 Offer multiple marker maternal serum analyte screening to all pregnant women at gestational ages between 15 and 20 weeks ACOG, 2007 Haddow et al., 1992 Malone et al., 2005 II-1 Good B 2 Provide pre-test patient education and counseling Nadel et al., 1990 Dahl et al., 2006 Davey et al., 2005 II-2 Good B 3 Women at high-risk for fetal aneuploidy (age =35 at delivery or prior first child or fetus with aneuploidy) require genetic counseling Haddow et al.,1994 II-1 Good B 4 Screen-positive women require targeted ultrasound examination for Smith-Bindman et al., 2001 ACOG, 2007 II-1 Good B Interventions Page - 73
VA/DoD Clinical Practice Guideline For Pregnancy Management risk modification and counseling prior to decision for invasive testing 5 Women with persistent unexplained elevations of maternal serum AFP are at increased risk for adverse prenatal outcome ACOG, 2007 SOGC, 2008 Dugoff et al., 2005 I Good A LE = Level of Evidence; QE = Quality of Evidence; SR = Strength of Recommendation (See Appendix A) Ultrasound Ultrasound is commonly used in pregnancy for other indications (see I-37). These ultrasounds are performed for a host of reasons to include earlier detection of severe anomalies, confirmation of dating, general assessment of fetal well-being, and maternal reassurance. It is not possible to completely separate aneuploidy screening from the above when ultrasounds are performed. Counseling Multiple factors may influence a woman’s decision regarding which, if any, tests to choose. These factors may include: local availability of the testing, cost of the testing, the position of the woman/family regarding whether or not she would continue a pregnancy given an adverse fetal condition and whether or not she would consider the risk of diagnostic testing to be worth gaining this information. In order for a woman to come to an informed decision about which method of testing, if any, to undergo, she must be carefully counseled. Because of the complexity and changing nature of the currently available testing, extensive counseling is required to clarify the nature of the testing and allow appropriate informed consent. Unfortunately, many patients perceive the counseling they were provided as inadequate (Dahl et al., 2005). Few studies evaluated the relative efficacy of various approaches to genetic counseling. Methods limited to brief counseling alone lead to higher rates of dissatisfaction with care and with testing, and are inadequate for women making decisions about such testing (Dahl et al., 2006; Davey et al., 2005). Audio-visual counseling was found to be an effective means to educate patients about genetic screening and does not require a trained genetics professional to administer (Fries et al., 2005). In another randomized trial (Hunter et al., 2005) assessing changes in knowledge, decisional conflict, state anxiety, satisfaction, and pregnancy outcomes, all participants showed a significant increase in knowledge and a decrease in decisional conflict post-intervention. While all reported high levels of satisfaction, those in individual counseling were significantly more satisfied than those receiving group counseling or the decision aid. This study has shown unique benefits with each type of intervention such that women and their partners preferred individual genetic counseling, while they learned best in group counseling sessions, and experienced the least decisional conflict regarding genetic testing with a decision aid. Comprehensive Counseling should include: • Initial brief counseling/information This counseling/information, ideally provided in the first trimester, seeks to provide summary information and identify women who desire to forgo any screening or diagnostic testing for fetal aneuploidy/anomalies and to provide an opportunity for women to begin to consider screening/testing options. • Comprehensive prescreen/pretest counseling. This counseling should be comprehensive in nature and should be provided to all women who are considering undertaking a screening strategy or diagnostic testing for fetal aneuploidy/anomalies. Comprehensive counseling should include information regarding the elective nature of the testing, the various available screening strategies, the potential benefits and limitations of screening tests, the potential risks and benefits of diagnostic testing, the locally available diagnostic testing strategies, and the financial and institutional limitations of pregnancy termination in the DoD/VA. • Posttest counseling. This counseling should be provided to all women who have undergone screening or diagnostic testing when the result of the testing is abnormal or “high risk.” This posttest counseling should include a discussion of the significance of the result, including its limitations such as the false positive rate and an outline of further options and management strategies for the woman and her family. Interventions Page - 74
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Management of pregnancy - VA/DoD Clinical Practice Guidelines ...

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