Recommendation IV1 Develop guidelines for the reporting of infant outcomes

National Institutes of Health, the U.S. Department of Education, other funding agencies, and investigators should develop guidelines for determining and reporting outcomes for infants born preterm that better reflect their health, neurodevelopmental, educational, social, and emotional outcomes across the life span and conduct research to determine methods that can be used to optimize these outcomes.


• Outcomes should be reported by gestational age categories, in addition to birth weight categories; and better methods of measuring fetal and infant maturity should be devised.

• Obstetrics-perinatology departments and pediatrics-neonatology departments should work together to establish guidelines to achieve a more uniform approach to evaluating and reporting outcomes, including ages of evaluation, measurement tools, and the minimum duration of follow-up. The measurement tools should cover a broad range of outcomes and should include quality of life and the elicitation of outcome preferences from adolescents and adults born preterm and their families.

• Long-term outcome studies should be conducted into adolescence and adulthood to determine the extent of recovery, if any, and to monitor individuals who were born preterm for the onset of disease during adulthood as a result of being born preterm.

• Research should identify better neonatal predictors of neurodevelopmental disabilities, functional outcomes, and other long-term outcomes. These will allow improved counseling of the parents, enhance the safety of trials of interventions for mothers and their infants by providing more immediate feedback on infant development, and facilitate planning for the use of comprehensive follow-up and early intervention services.

• Follow-up and outcome evaluations for infants involved in maternal trials of prenatal means of prevention or treatment of threatened preterm delivery and infant trials of means of prevention and treatment of organ injury not only should report the infant's gestational age at delivery and any neonatal morbidity but also should include neurological and cognitive outcomes. Specific outcomes should be tailored to answer the study questions.

• Research should identify and evaluate the efficacies of postnatal interventions that improve outcomes.

3. Study Infertility Treatments and Institute Guidelines to Reduce the Number of Multiple Gestations

The use of infertility treatments has risen dramatically in the past 20 years and has been associated with the trend to delay childbearing. In 2002, 33,000 American women delivered babies as a result of assisted reproductive technology (ART) procedures, more than twice the number who had done so in 1996 (Meis et al., 1998). More than 50 percent of these women were 35 years of age or older. In recent years, an unintended consequence of these technologies, multiple gestations and the increased risk for preterm delivery, has become a focus of attention. There is also evidence of an association between the underlying causes of infertility and subfecundity (long time to becoming pregnant) and preterm birth (Henriksen et al., 1997; Joffe, 1994). Pre-term birth in relation to ART may be different in its pathogenesis than most other cases.

ART involves procedures in which the egg and sperm are handled in the laboratory, including in vitro fertilization (IVF) procedures. Since 1996, the federal government has mandated that all clinics performing ART procedures report their outcomes to the CDC (Meis et al., 1998). Even though ART use must be reported, other reproductive technologies not classified as ART are not. The CDC definition of ART does not include treatments in which only sperm are handled (for example, for intrauterine or artificial insemination) or procedures in which a woman takes medication to stimulate egg production without the intention of having eggs retrieved. The frequency of use and the number of births attributable to this technique are unknown. This is an important gap in current knowledge.

Multiple gestations are more common in assisted reproduction than in natural conception. The major cause underlying the increased risk of multiples with ART is the number of embryos transferred. National data indicate that in the United States, the majority of ART cycles involve the transfer of more than one embryo, with more embryos transferred as maternal age increases (CDC, 2003). There is a direct relationship between the rise in assisted reproduction use and the increase in multiple gestations. Fifty-three percent of 45,751 infants born through the use of ART in the United States in 2002 were multiples. Much of the focus on the causes of multiple gestations has been placed on the role of ART, particularly IVF. Much less attention has been paid to the role of ovulation promotion (superovulation-intrauterine insemination and conventional ovulation induction), which is equally important in terms of the contribution to multiple gestations. The risk of multiple gestations secondary to these treatments is less well documented, as reporting data are not mandated.

The primary concern regarding ART and ovulation promotion is the risk of preterm delivery in association with multiple gestations. Among the infants conceived through ART specifically, 14.5 percent of singletons, 61.7 percent of twins, and 97.2 percent of higher-order multiples were born at gestational ages of less than 37 weeks (CDC, 2005a). The results of a recent meta-analysis revealed that singletons conceived by IVF are twice as likely to be born preterm and die within 1 week of birth compared with the risk for those not conceived through IVF (McGovern et al., 2004). The etiology of this type of preterm birth remains unknown. This is an important area for future research.

In 1999, the American Society for Reproductive Medicine issued guidelines that recommended limiting the number of embryos transferred. The guidelines were further refined in 2004. A demonstrable drop in the rate of triplet gestations from 7 to 3.8 percent from 1996 to 2002 has been cited as evidence of the success of these practice guidelines (Barbieri, 2005). Despite success in reducing rates of higher-order multiples, the United States does not fare as well as European countries in minimizing the risk of multiple gestations (Anderson et al., 2005).

Recommendation II-4: Investigate the causes of and consequences for preterm births that occur because of fertility treatments. The National Institutes of Health and other agencies, such as the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality, should provide support for researchers to conduct investigations to obtain an understanding of the mechanisms by which fertility treatments, such as assisted reproductive technologies and ovulation promotion, may increase the risk for preterm birth. Studies should also be conducted to investigate the outcomes for mothers who have received fertility treatments and who deliver preterm and the outcomes for their infants.

Specifically, those conducting work in this area should attempt to achieve the following:

• Develop comprehensive registries for clinical research, with particular emphasis on obtaining data on gestational age and birth weight, whether the preterm birth was indicated or spontaneous, the outcomes for the newborns, and perinatal mortality and morbidity. These registries must distinguish multiple gestations from singleton gestations and link multiple infants from a single pregnancy.

• Conduct basic biological research to identify the mechanisms of preterm birth relevant to fertility treatments and the underlying causes of infertility or subfertility that may contribute to preterm delivery.

• Investigate the outcomes for preterm infants as well as all infants whose mothers received fertility treatments.

• Understand the impact of changing demographics on the use and outcomes of fertility treatments.

• Assess the short- and long-term economic costs of various fertility treatments.

• Investigate ways to improve the outcomes of fertility treatments, including ways to identify high-quality gametes and embryos to optimize success through the use of single embryos and improve ovarian stimulation protocols that lead to monofollicular development.

Recommendation II-5: Institute guidelines to reduce the number of multiple gestations. The American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, and state and federal public health agencies should institute guidelines that will reduce the number of multiple gestations. Particular attention should be paid to the transfer of a single embryo and the restricted use of superovulation drugs and other nonassisted reproductive technologies for infertility treatments. In addition to mandatory reporting to the Centers for Disease Control and Prevention by centers and individual physicians who use assisted reproductive technologies, the use of superovulation therapies should be similarly reported.

4. Improve the Quality of Care for Women at Risk for Preterm Labor and Infants Born Preterm

Beyond the content of prenatal care, little is known about the quality of care throughout the reproductive spectrum. For infants born preterm, there are also few indicators of high-quality NICU care. Knowledge of the quality of care received during pregnancy and delivery has the potential to reduce the rates of preterm birth. However, few quality measures related to the perinatal period have been developed. Reporting systems such as the National Center on Quality Assurance's HEDIS (Health Plan Employer Data and Information Set; measures contain only a few basic indicators related to the timing and content of prenatal care and the birth outcome.

In general, large variations in outcomes exist across NICUs that cannot be explained by patient mix or other readily observable hospital characteristics, such as patient volume and level of care. Recent research has suggested a role for the organizational and management structures of NICUs in ensuring good patient outcomes (Pollack et al., 2003). More research on the determinants of high-quality care will be needed to be able to send patients to the best hospitals.

Recommendation V-2: Establish a quality agenda. Investigators, professional societies, state agencies, payors, and funding agencies should establish a quality agenda with the intent of maximizing outcomes with current technology for infants born preterm.

This agenda should:

• Define quality across the full spectrum of providers who treat women delivering pre-term and infants born preterm;

• Identify efficacious interventions for preterm infants and identify the quality improvement efforts that are needed to incorporate these interventions into practice; and

• Analyze variations in outcomes for preterm infants among institutions.

5. Investigate the Impact of the Health Care Delivery System on Preterm Birth

Policy makers have focused on expansion of access to prenatal care since the 1980s in an effort to improve birth outcomes in general, including a reduction in preterm birth rates. These efforts have primarily been achieved through the expansion of Medicaid eligibility for pregnant women at the state level. A direct link between the availability of increased insurance and the receipt of early prenatal care was demonstrated in a study of Medicaid expansion in Florida (Long and Marquis, 1998).

Alternately, states can increase access to prenatal care outside of the confines of Medi-caid by expanding programs that target uninsured pregnant women to provide them with access to prenatal care through Maternal and Child Health block grants (Schlesinger and Kronebusch, 1990). Coverage for prenatal care services has also been extended through expansion of the State Children's Health Insurance Program (SCHIP) [Title XXI, Social Security Act, Pub. I, No. 74271 (49 Stat 620) (1935)].

Evaluations of the Medicaid expansions have not found reduced rates of preterm birth or improvements in maternal outcomes in association with these increases in the levels of insurance coverage for pregnant women (Piper et al. 1990). One reason that the expansions may not have been effective in reducing the rates of preterm birth may be that current prenatal care is focused on risks other than preterm birth (see Chapter 9). Nonetheless, prenatal care provides the framework though which interventions can be implemented and thus plays an important role in the potential to reduce preterm birth rates in the future.

The organization of the health care delivery system has long been viewed as a key determinant of birth outcomes. In the 1970s, the March of Dimes developed practice guidelines advocating for the regionalization of perinatal care in the United States (Committee on Perinatal Health, 1976), based on research linking the regionalization of neonatal care with improved neonatal survival and overall outcomes. As initially envisioned, regionalized perinatal care involved the designation of three levels of care on the basis of the clinical conditions of the pa-tients—both the mother and the infant. Level I centers were able to provide basic or routine obstetrical and newborn care, whereas Level II centers had the capability to care for patients of moderate risk, with Level III centers being reserved for those with the ability to tend to the most specialized high-risk cases. In addition to the designation of levels, regionalized perinatal care was to include the coordination of care among the region's hospitals.

Research demonstrated an increase in regionalization with a concomitant marked improvement in the rates of survival of the neonates (McCormick et al., 1985). By the latter half of the decade, however, the emphasis on the regionalization of perinatal care was being replaced by an interhospital competition driven by the reimbursement policies of an increasingly managed care environment. To compete for managed care contracts and to maintain and attract obstetric patients, smaller community hospitals were hiring neonatalogists and building new NICUs, even in the absence of increased obstetric volume or the ability to provide comprehensive neonatal services.

Follow-up studies revealed a reversal in regionalization, increased competition between hospitals, and blurred distinctions between levels of care (Cooke et al., 1988). Between 1990 and 1994 an increase in the number of self-designated Level II facilities occurred compared with the number between 1982 and 1986, with a concomitant decrease in the number of Level I institutions (Yeast et al., 1998). However, the relative risk of neonatal mortality for infants born with very low birth weights was twofold higher in Level II centers than in Level III centers.

More recently, the private sector has begun a trend toward moving patients to high-quality hospitals through evidence-based selective referral. Evidence-based hospital referral in its broadest sense means making sure that patients with high-risk conditions are treated in hospitals with the best outcomes. Evidence-based hospital referral standards for infants with very low birth weights required that infants with expected birth weights of less than 1,500 grams, a gestational age of less than 32 weeks, or correctable major birth defects should be delivered at a regional NICU with an average daily census of 15 patients or more. Evidence suggests that although patient volume and NICU level of care are statistically significant determinants of outcomes, they explain little of the variation in the rates of mortality among very-low-birth-weight infants among hospitals (Rogowski et al., 2004). In general, large variations in outcomes exist among NICUs that cannot be explained by patient mix or other readily observable hospital characteristics, such as volume and level of care. More research will be needed on the determinants of high-quality care so that patients may be sent to the best hospitals.

Recommendation V-3: Conduct research to understand the impact of the health care delivery system on preterm birth. The National Institutes of Health, the Agency for Healthcare Quality and Research, and private foundations should conduct and support research to understand the consequences of the organization and financing of the health care delivery system on access, quality, cost, and the outcomes of care as they relate to preterm birth throughout the full reproductive and childhood spectrum.

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