Please note: In 2003, the CTF updated its Grades of Recommendations to include an "I Recommendation" for situations where insufficient evidence exists to allow a recommendation to be made.  (Formerly, these situations were captured under a "C Recommendation".)  This change is not retroactive, and all "C Recommendations" made prior to 2003 have not been reevaluated in light of the new "I" recommendation grade.  For a discussion of these recommendation grades, please link to the 2003 article in the Canadian Medical Association Journal here.

Primary Prevention of Fetal Alcohol Syndrome

Overview
In 1979 the Canadian Task Force on the Periodic Health Examination found there was fair justification for recommending that counselling to reduce alcohol intake in pregnant women should be included in the periodic health examination (B recommendation).< 1,2> This was based on evidence that counselling was effective in reducing both the amount of drinking in pregnant women and morbidity in their offspring. The evidence since 1979 supports the original recommendation. Also considered was contraception for alcoholic sexually active women, and, if acceptable, the offer of abortion for pregnant women at high risk.

More general concerns regarding problem drinking have been dealt with in Chapter 42 and are beyond the scope of this report. In brief, however, in 1989<3> and again in this update the Task Force found there was fair evidence that case-finding, counselling and follow-up are effective in managing problem drinking. This volume also contains a separate report on the psychological consequences to children of having alcoholic parents (Chapter 41).

Burden of Suffering
Fetal Alcohol Syndrome (FAS) refers to a constellation of congenital and functional anomalies occurring in children born to alcohol-abusing women. First documented in 1973 by Jones and Smith,<4> FAS has become one of the most actively researched congenital abnormalities in the last two decades.<5> Criteria for defining FAS were standardized by the Fetal Alcohol Study Group<6> and modifications were proposed in 1989 by Sokol and Clarren.<7> FAS is now one of the leading causes of mental retardation. It has been estimated that 50% of FAS victims are mentally retarded and another 30% suffer borderline mental retardation.<8> It is generally accepted that the harmful effects of prenatal alcohol exposure can be plotted on a continuum, with spontaneous abortion at one end, FAS in the middle and subtle behavioral abnormalities at the other end of the scale. FAS represents the severest disabilities caused by maternal alcohol use during pregnancy. The term "possible fetal alcohol effects" (FAE) has been introduced to indicate that alcohol is being considered as one of the possible causes of a patient’s birth defects, but there are not sufficient features for a firm diagnosis of FAS or strong evidence of an alternative diagnosis.<7>

The accurate determination of the incidence of FAS is difficult primarily because the syndrome is not reliably recognized. It has been reported that between 8% and 11% of child-bearing women in the United States are either problem drinkers or alcoholics. Further, it has been reported that 65% of fetuses are exposed to alcohol prenatally throughout the United States. Between 3% and 10% of pregnant women report patterns of alcohol consumption that have corresponded with harming the fetus.<9> This figure may be low as it is generally accepted that self-reporting of alcohol consumption in women is under-reported due to denial. The precise incidence and prevalence of FAS and FAE are not known in Canada. It is estimated that the incidence rate of FAS is between 1 and 2 per 1,000 live births in the general population. Based on these data, between 400 to 500 Canadian children are born annually with FAS. The incidence of FAS is markedly increased in the native population and in poor, inner-city neighbourhoods, as well as rural, remote villages. The highest reported prevalence of FAS is one child in eight in a native community in British Columbia where all mothers and their offspring were systematically evaluated.<10>

Experts agree that the actual amount of alcohol needed to produce FAS and the precise risk of embryo-fetal damage is largely unknown. It is widely accepted that there is a dose-response relationship, but it is not known how large a dose is needed to cause an injurious effect to the fetus. Investigators<11,12> report that the teratogenicity of alcohol is strictly dose dependent with direct dose-response effects on infant weight, perinatal mortality and soft-tissue malformations.

Lastly, it is known that not all alcoholic women are at risk for giving birth to an alcohol-affected child; genetic and physiologic factors may mediate the risk.<13> Ethnic and cultural factors, family history and tobacco and multiple drug use have been identified as variables that may mediate the risk of morbidity in the offspring of alcoholic mothers.

Maneuver
It is known that, unlike other congenital birth defects, alcohol-related birth defects are preventable. Experts agree that the development of effective screening methodologies to identify women at high risk for heavy alcohol consumption is the key strategy to preventing alcohol-related birth defects. Determining the need for education, counselling and treatment for these patients is dependent on recognition of the patient’s problem. Identifying high-risk drinkers is difficult for physicians, however. Laboratory tests which might identify biochemical markers of heavy drinking are not available<14> and obtaining an accurate history of maternal alcohol consumption can be complicated by psychological denial.

A number of screening tests for the estimation of alcohol consumption are available. The Michigan Alcoholism Screening Test (MAST) is a 25-question instrument which is extensively utilized for research but is time consuming and thus clinically impractical.<15> The CAGE test is a more recent and effective screening test; it is only four questions long, but has not been studied in pregnancy.<16> Recently, a screening test for the early detection of hazardous and harmful alcohol consumption for use in primary care settings has been developed by the World Health Organization.<17> Again, it has not been specifically tested on pregnant populations.

In 1988, Cyr and Wartman<18> proposed two questions that would improve the practitioner’s chances of identifying the alcoholic patient. The questions, "Have you ever had a drinking problem?" combined with "When was your last drink?" had a sensitivity of 91.5%. The researchers recommend the routine incorporation of these two questions into the medical history of the outpatient population to aid in the initial diagnosis of alcoholism.

Sokol and colleagues<19> developed a four-question survey tool to help eliminate denial and under-reporting of heavy drinking by pregnant women. Referred to as the T-ACE, the questionnaire accurately identified 69% of the risk drinkers from a cohort of 971 pregnant women. T-ACE was determined to be superior to other standard questionnaires such as MAST and CAGE for detecting heavy alcohol abuse. Another instrument, a brief Ten Question Drinking History (TQDH) has been incorporated into the Boston City Hospital prenatal clinic record.<20> Reliability has been demonstrated, and the data obtained by obstetrical staff using the TQDH were comparable to those obtained in a more elaborate research interview.

It remains a diagnostic challenge to gain an accurate drinking history from many patients. Laboratory results may prove to be entirely normal though risk-drinking exists. Obtaining a thorough and sensitive history from a possibly evasive and denying patient remains the best technique for identifying risk-drinking.<21> Two points should be kept in mind about screening pregnant women for alcohol intake. It is likely that if the patient screens positive, the response is accurate. However, a negative result on the screen is not necessarily accurate. Second, if the goal is to eliminate all maternal drinking during pregnancy, then the screen simply has to identify any vs. no alcohol intake rather than varying levels of alcohol use.

In the absence of a clearly defined safe threshold for alcohol consumption during pregnancy, experts widely agree that the most conservative approach is best. Therefore, most clinicians advise total abstinence for women who are either considering pregnancy or who are pregnant. This widely accepted recommendation has not gone unchallenged, however. Knupfer<22> has argued that there is no evidence that light drinking is harmful to the fetus and that defects exist in the literature regarding methodologies for categorizing drinking patterns and drawing conclusions from them.

Effectiveness of Prevention
As it is widely accepted that there is no effective treatment for offspring with FAS and FAE, the challenge to physicians and other health care providers lies in the prevention of FAS and FAE through early identification of women who are abusing alcohol and the implementation of treatment interventions with the mother.

Patient Intervention
Several studies have noted the positive benefits of interventions during pregnancy with alcohol-abusing women. Coles and coworkers<23> found that infants of mothers who stopped consuming alcohol in the second trimester displayed less growth retardation and fewer neurobehavioural deficits than neonates of women who continued to drink at the same rate throughout the pregnancy. Other researchers have noted that the risk for intrauterine growth retardation and central nervous system effects decrease in the newborns of mothers who lessen or discontinue their alcohol use during pregnancy.

In one study, alcohol counselling was provided to 85 pregnant women to persuade them to reduce or eliminate their alcohol consumption. Sixty-five percent of the women were able to decrease their alcohol intake by at least 50%. In the total sample, 24% of the offspring had complete FAS, while 26% displayed FAE. Of the women with continuous alcohol consumption, 89% gave birth to neonates with at least one FAE feature compared with only 40% of women who reduced their alcohol intake.<24>

There is evidence that therapeutic interventions in the prenatal clinic setting can be effective in promoting a decrease in alcohol intake, even in high-risk heavy drinkers. Rosett and Weiner<25> reported that 67% of a group of heavy drinkers either decreased or abstained from alcohol use following an intervention of supportive counselling. Larsson<26> reported similar results in that 76% of the women either decreased or eliminated drinking following a minimal intervention which consisted mainly of the provision to the mothers of information about the effects of alcohol consumption during pregnancy. The results of these studies suggest that alcohol-abusing women are responsive to intervention during pregnancy, possibly more so than at any other time.

Professional Education
The literature substantiates a lack of awareness among health care providers regarding the range of symptoms associated with FAS and FAE. Many clinicians do not comprehend the ramifications correlated with these diagnoses for the child’s development. The diagnosis of alcoholism is often missed as well. Sokol and colleagues<27> have found that clinicians are failing to diagnose alcoholism in at least three of four alcohol-abusing patients. The researchers believe that no other diagnosis is missed as frequently. There are many reasons why doctors do not routinely ask about alcohol consumption among their pregnant patients. Such explanations include physician bias regarding their own abuse, inadequate training for the task, poor awareness of the problem and its consequences, time restrictions, disinterest, fear of offending the patient, disbelief and denial that FAS occurs in private practice and the view that patients will deny their alcohol use.

Role of the Physician
Several authors stress the importance of the doctor-patient interaction as key in the prevention of alcohol-related birth defects. As many communities have limited resources available to women of child-bearing age, the role of the clinician providing perinatal care becomes even more critical.

Public Prevention Strategies
There are few empirical studies regarding the impact of warning labels on alcohol beverage containers. This is not surprising as Canada does not have legislation requiring warning labels and the U.S. only recently enacted the warning label law in November 1989. However, there is evidence that warning labels can influence behaviour based on studies regarding tobacco, foods and illegal drugs. Further, evidence exists supporting the idea that public educational efforts are effective in modifying behaviour, especially among social drinkers.

Recommendations of Others
The Canadian Medical Association strongly supports all activities that encourage Canadians to reduce their alcohol intake. The Association recommends that the Federal Government prohibit all advertising of alcoholic beverages on radio and television, as well as in printed materials. A Health and Welfare Sub-Committee has recommended to the Minister that the Food and Drug Act be amended to require that alcohol beverage containers sold in Canada carry appropriate warning labels alerting consumers that alcohol consumption during pregnancy places the fetus at risk of FAS and FAE. Lastly, the recommendations of American medical organizations are in agreement with those of the Canadian medical community, in that total avoidance of alcohol consumption during pregnancy is the safest course of action. Abstinence of maternal drinking is the official recommendation of the U.S. Surgeon General, the American College of Obstetricians and Gynecologists, the American Council of Science and Health, as well as the American Medical Association Council on Scientific Affairs.  In 1989, the U.S. Preventive Services Task Force recommended that all persons who use alcohol, especially pregnant women, should be encouraged to limit their consumption.<28>

Conclusions and Recommendations
The child born to an alcoholic mother is at risk for the development of craniofacial anomalies, mental retardation and a wide spectrum of developmental delays. There is evidence that counselling is an effective intervention in decreasing both the amount of drinking in pregnant women and morbidity in their offspring.

There is fair justification to support the recommendation that screening and counselling be included in a routine health examination of pregnant women (B Recommendation).

Unanswered Questions (Research Agenda)
The following have been identified as research priorities:

1. Determining the incidence of FAS and FAE in Canada, among the Canadian population in general, as well as in subpopulations known or suspected to be at higher risk for these disorders.
2. Improving the ability of clinicians to identify accurately the drinking patterns of pregnant women.
3. Improving knowledge about fetal and maternal susceptibility to alcohol, time of exposure during pregnancy, effects of varying quantity and concentration of alcohol, patterns of drinking, as well as other dose-response relationships which further define the embryonic and fetal risk.
4. Evaluating promising treatment programs for alcoholic women.
5. Increasing public awareness of the effects on the offspring of maternal alcohol consumption during pregnancy.
6. Determining the effectiveness in high-risk populations (eg., Natives) of counselling to reduce the consumption of alcohol in pregnant women.

Acknowledgements
Funding for this report was provided by Health Canada under the Government of Canada’s Brighter Futures Initiative. The Task Force thanks Tim Oberlander, MD, FRCPC, Developmental Pediatrician, Assistant Professor of Pediatrics, University of British Columbia, Vancouver, BC; and Sarah Shea, MD, FRCPC, Assistant Professor of Pediatrics, Dalhousie University, Halifax, NS for reviewing the draft chapter.

Full Citation
Offord D.R. & Craig D.L. Primary prevention of fetal alcohol syndrome. In: Canadian Task Force on the Periodic Health Examination. Canadian Guide to Clinical Preventive Health Care. Ottawa: Health Canada, 1994; 52-61.