Population-based case-control study of oxoline acid use during pregnancy for birth outcomes

The objective of the study was to check the effect of oxoline acid, a bactericidal drug for the treatment of urinary tract infection during pregnancy, on congenital abnormalities of informative offspring and fetal development. Human data of oxoline acid use during pregnancy have not been reported, but the use of this quinolone derivative is not recommended during pregnancy by the US Food and Drug Administration. The teratogenic and fetotoxic potential of oxoline acid was evaluated in the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. Observed and expected numbers of congenital abnormalities were compared in the newborn infants and fetus of case mothers with oxoline acid treatment. In addition, gestational age and birthweight were evaluated in control newborn infants born to mothers with or without oxoline acid treatment. Of 38,151 newborn infants without any congenital abnormalities (control group), 13 (0.03%) had mothers who were treated with oxoline acid, while of 22,843 cases with congenital abnormalities, five (0.02%) had mothers who were treated with oxoline acid during pregnancy (POR with 95% CI: 0.6, 0.2-1.8). The comparison of observed and expected number of different congenital abnormalities did not show the teratogenic potential of oxoline acid. There was a 0.9 weak shorter gestational age without a smaller birthweight in the newborn infants born to mothers with oxoline acid treatment. Our data did not indicate teratogenic and fetotoxic effect of oxoline acid, however, the number of cases and controls was limited.     

Population-based case-control teratologic study of topical miconazole

Miconazole cream is used in Hungary to treat fungal genital and skin infections in pregnant women, but it causes anxiety for both patients and medical doctors due to the category C classification of the drug regarding teratogenic or fetotoxic risk. The objective of this case-control study was to analyze the teratogenic potential of topical miconazole used during pregnancy in the mothers of babies with congenital abnormalities and in matched control mothers of babies without congenital abnormalities. The population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996 included 22 843 women who had newborns or fetuses with congenital abnormalities, and 38 151 pregnant women who had newborn infants without any defects (controls). In the case group, 24 (0.11%) and in the control group, 46 (0.12%) pregnant women were treated with miconazole (crude odd ratio [OR]: 0.9 with 95% confidence interval [CI]: 0.6-1.6). Different congenital abnormality groups were evaluated in case-control pairs and a higher prevalence of miconazole treatment was not found during the second or third month of pregnancy. Thus, treatment with topical miconazole during pregnancy does not increase the risk of congenital abnormalities.     

Teratogenic potential of pholedrine: A sympathomimetic vasoconstrictive drug – A population‐based case‐control study

Pholedrine was a frequently used drug for the treatment of severe hypotension in some countries, including Hungary. The possible teratogenic effect of pholedrine was not checked; therefore; the birth outcomes, particularly congenital abnormalities (CAs), of infants born to women treated with pholedrine during pregnancy, and pregnancy complications were evaluated in the population‐based large dataset of the Hungarian Case‐Control Surveillance System of Congenital Abnormalities. Cases with CA and their matched controls without CA born to mothers with pholedrine use during pregnancy were compared. Of 22 843 cases and 38 151 controls, 768 (3.4%) and 1509 (4.0%) were born to mothers with pholedrine treatment, respectively (adjusted odds ratios [OR] with 95% CI: 0.9, 0.8–1.0). There was no higher risk for any CA group in the offspring of mothers who used pholedrine during the second and/or third month of pregnancy (i.e. the critical period of most major CA). The mean gestational week at delivery and birthweight was similar in newborns of women with or without pholedrine treatment during pregnancy. The pattern of pregnancy complications was characteristic (lower incidence of preeclampsia/eclampsia, while higher incidence of severe nausea/vomiting and anemia), explained mainly by the underlying maternal hypotension. In conclusion, pholedrine treatment in pregnant women was not associated with a higher risk for CA or other adverse birth outcomes, such as preterm birth or low birthweight. The knowledge of the teratogenic potential of pholedrine may contribute to the evaluation of other sympathomimetic drugs.     

Population-based case-control study of oral ketoconazole treatment for birth outcomes

The objective of the study presented here was to check the effect of oral ketoconazole treatment on fetal development. Ketoconazole has been given a teratogenic classification of C by the US Food and Drug Administration, but human controlled epidemiological studies of the treatment's effects have not been reported. The occurrence of ketoconazole use in the second to third months of gestation was compared between cases with congenital abnormalities and their matched controls in the large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996. Birth weight and gestational age were evaluated in control newborn infants born to mothers with or without ketoconazole treatment. The case group comprised 22,843 cases with congenital abnormalities, while the control group contained 38,151 newborn infants without any defects. Six infants (0.03%) and 12 controls (0.03%) had mothers who had received oral ketoconazole treatment (prevalence odds ratio: with 95% confidence interval: 0.8, 0.3-2.2). No group of infants with congenital abnormalities had mothers with a higher incidence of use of the drug. The mean gestational age was somewhat longer while birth weight was somewhat larger in controls with ketoconazole treated mothers. Our study failed to demonstrate a higher rate of congenital abnormalities in infants with mothers who had received oral ketoconazole treatment during pregnancy.     

Peptic ulcer disease with related drug treatment in pregnant women and congenital abnormalities in their offspring

Peptic ulcer disease (PUD) is a common disease which can also occur in pregnant women. However, the possible association of PUD and related drug treatments in pregnant women with the risk of structural birth defects (i.e. congenital abnormalities [CA]) in their offspring has not been estimated in controlled population‐based epidemiological studies. Thus, the prevalence of PUD in pregnant women who later delivered babies (cases) with different CA and in pregnant women who delivered newborns without CA (controls) was compared in the Hungarian Case‐Control Surveillance of Congenital Abnormalities. Controls were matched to cases. Of 22 843 cases with congenital abnormalities, 182 (0.80%) had mothers with reported/recorded PUD, while of 38 151 controls, 261 (0.68%) were born to mothers with reported/recorded PUD. However, PUD(?) based on maternal information and/or unspecified diagnostic criteria, and PUD(!) based on endoscopic diagnosis showed different variables of mothers and newborn infants. Thus, finally, 20 case mothers and 58 control mothers with PUD(!) and related drugs were evaluated in detail. There was no higher risk for total CA group in the offspring of mothers with PUD during pregnancy (adjusted OR with 95% CI: 0.6, 0.3‐0.9). Specific CA groups in cases were also assessed versus controls, but specified CA had no higher risk in the offspring of pregnant women with PUD and related drug treatments. In conclusion, a higher rate of CA was not found in the offspring of mothers with PUD.     

Possible association between different congenital abnormalities and use of different sulfonamides during pregnancy

The objective of the study presented here was to check the debated human teratogenic potential of sulfonamide drugs. Five different sulfonamides such as sulfamethazine, sulfathiourea, sulfamethoxypyridazine, sulfamethoxydiazine and the combination of sulfamethazine-sulfathiourea-sulfamethoxypyridazine were differentiated. Cases with congenital abnormalities were compared with their matched controls without congenital abnormalities in the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. Of 38,151 newborn infants without any congenital abnormalities (control group), 163 (0.4%) had mothers who were treated with the sulfonamides studied during pregnancy, while of 22,843 cases with congenital abnormalities, 140 (0.6%) had mothers who were treated with the sulfonamides studied during pregnancy. The analysis of cases and matched controls indicated a higher rate of cardiovascular malformation (adjusted prevalence odds ratios [POR] with 95% CI: 3.5, 1.9-6.4) and clubfoot (adjusted POR with 95% CI: 2.6, 1.1-6.2) in infants born to mothers with sulfonamide treatment in the second and third months of pregnancy. The detailed analysis of different sulfonamides showed a possible association between cardiovascular malformations (adjusted POR with 95%; CI: 6.5, 2.6-15.9), particularly ventricular septal defect (17.1, 1.3-141.1) and sulfamethoxydiazine during the second and third months of pregnancy. In addition, a possible association was found between clubfoot and sulfathiourea, both during the entire pregnancy (adjusted POR with 95% CI: 2.3, 1.2-4.3) and in the second and third months of gestation (3.9, 1.1-13.8). Thus, maternal treatment of sulfamethoxydiazine may cause ventricular septal defect, while sulfathiourea may induce clubfoot; however, further studies are needed to verify or reject these associations.     

Perinatal consequences of maternal connective tissue diseases: a prospective study of 73 cases]

AIM: To describe a group of newborns born from mothers with connective tissue diseases, to determine their perinatal characteristics and the neonatal morbidity, and to assess the possible role of drugs received by mothers on the obstetrical and neonatal morbidity. PATIENTS AND METHODS: During a 34-month period, newborns born from mothers with connective tissue diseases and followed in a single center were prospectively included in the study. In all cases, maternal treatments (i.e. hydroxychloroquine and/or prednisone) were continued during pregnancy. RESULTS: Among the 73 included infants, 18 (25%) were born before 37 weeks of gestation and 3 (4%) were small for gestational age. A neonatal lupus syndrome with facial rash and thrombopenia was observed in 1 case. No neonatal congenital heart block was observed and maternal treatment did not significantly influence the mean PR or QT intervals. Four infants had minor congenital abnormalities and 3 had feto-maternal infection. CONCLUSION: These data show that perinatal morbidity is lower than that previously published. We postulate that a strict follow-up during pregnancy may have played a significant positive role in these results.     

系统性红斑狼疮合并妊娠子代早产儿42例临床分析

目的 探讨系统性红斑狼疮（SLE）合并妊娠子代早产儿的临床特点,提高新生儿科医师对这部分早产儿的认识。方法 收集2000年1月至2012年6月间SLE合并妊娠子代早产儿的临床资料进行回顾性分析,并与同期出生的除SLE合并妊娠子代早产儿以外的2 308例早产儿住院期间并发症发生情况进行对比。结果 SLE合并妊娠子代早产儿共42例,女婴比例明显高于男婴,其中确诊新生儿狼疮综合征4例。新生儿感染为SLE合并妊娠子代早产儿最常见并发症（47.62%）,其次为小于胎龄儿（28.57%）,新生儿呼吸窘迫综合征（26.19%）,新生儿窒息和先天性心脏病（均为14.29%）,肺出血（4.76%）;与同期收治的2 308例早产儿合并新生儿感染（16.81%）、小于胎龄儿（13.21%）和先天性心脏病（5.16%）的发生率进行比较,差异均有统计学意义（均P<0.05）;其他合并症的发生率在两组早产儿间比较差异均无统计学意义。结论 SLE合并妊娠子代早产儿易合并感染性疾病、小于胎龄儿及先天性心脏病,而呼吸方面并发症与同期其他早产儿相比无显著差异。     

Congenital malformation among newborns at Dr. Pirngadi Hospital Medan during 1981-1984

A study on the incidence of congenital malformation had been assessed among 15,185 newborns delivered in the Neonatal Unit, Dr. Pirngadi Hospital Medan during 1981-1984. Still-births were not included in this study. Out of these 15,185 newborns there were 77 cases (0.51%) of congenital malformation. The four leading malformations were pes-equinovarus 7 cases (9.1%), labiognathopalatoschizis, hydrocephalus and anencephalus 6 cases each (7.7%). The number of congenital malformations was higher in the age group of mothers older than 35 years (0.78%) and in the group of babies born in the birth order as third and further (53.85%) and as first born babies (33.33%). From 77 cases with congenital malformation only 2 (2.56%) were operated soon after birth, while 49 cases (64.1%) went home without surgical intervention, and 28 cases (35.9%) died during hospitalization.     

Prenatal exposure to cigarette smoking is associated with a decrease in arousal in infants.

OBJECTIVE: Sudden infant death syndrome has been related to both exposure to prenatal cigarette smoke and impaired arousability from sleep. We evaluated whether healthy infants born to mothers who smoked during pregnancy had higher auditory arousal thresholds than those born to mothers who did not smoke and whether the effects of smoking occurred before birth. STUDY DESIGN: Twenty-six newborns were studied with polygraphic recordings for 1 night: 13 were born to mothers who did not smoke, and 13 were born to mothers who smoked (>9 cigarettes per day). Other infants with a median postnatal age of 12 weeks were also studied, 21 born to nonsmoking mothers and 21 born to smoking mothers. White noise of increasing intensity was administered during rapid eye movement sleep to evaluate arousal and awakening thresholds. RESULTS: More intense auditory stimuli were needed to induce arousals in newborns (P =.002) and infants (P =. 044) of smokers than in infants of nonsmokers. Behavioral awakening occurred significantly less frequently in the newborns of smokers (P =.002) than of nonsmokers. CONCLUSIONS: Newborns and infants born to smoking mothers had higher arousal thresholds to auditory challenges than those born to nonsmoking mothers. The impact of exposure to cigarette smoke occurred before birth.     

The Safety of Penicillin V: Oral Penamecillin Use During Pregnancy The Importance and Limitation of Recall Bias

The purpose of the study was to check the human teratogenic potential of penicillin V: oral penamecillin treatment during pregnancy in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The pairs of cases with congenital abnormalities and their matched population controls without congenital abnormalities were evaluated, in addition the data of total population and of patient control groups as referents were compared with the data of congenital abnormality groups. In the three study groups there were 38,151 pregnant women who had newborn infants without any defects (population control group), 22,865 pregnant women who had newborns or fetuses with congenital abnormalities, and 812 mothers of informative offspring with Down syndrome (patient controls). In the population control group 2,246 (5.9%) pregnant mothers were treated with penamecillin, in the case group 1,597 (7.0%) pregnant women had penamecillin treatment while in the patient control group 63 (7.9%) mothers used penamecillin during pregnancy. The use of penamecillin treatments during pregnancy was higher in the total case (i.e., congenital abnormality) group, than in the total population control group. However, the highest use of oral penamecillin was found in the patient control group. The case-matched population control pair analysis did not show a higher use of medically documented penamecillin during the second-third months of pregnancy, i.e., in the critical period for most major congenital abnormalities. In addition, an association between medically documented penamecillin use during the second and third months of gestation and different congenital abnormality groups was not found when total population control group or patient control groups were used as referent. Thus, the reported higher use of penamecillin among the mothers of cases and patient controls can be explained mainly by recall bias. Thus, treatment with oral penamecillin during pregnancy did not indicate detectable teratogenic risk to the fetus.     

A Population-based Case-Control Teratological Study of Three Parenteral Penicillins G

The purpose of the study was to check the human teratogenic potential of three penicillins G: parenteral treatments with benzylpenicillin, benzylpenicillin-procaine, and benzylpenicillin + benzylpenicillin-procaine during pregnancy in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980–1996. Of 38,151 pregnant women who had babies without any defects (population control group), 303 (0.8%) were treated with penicillin G. Of 22,865 pregnant women who had offspring with congenital abnormalities, 236 (1.O%) were treated with penicillin G (crude OR with 95% CI = 1.3, 1.1–1.5). Of 812 mothers who deliveried babies affected with Down syndrome (patient controls), 15 (1.8%) had penicillin G treatment, and this rate exceeded significantly the figure of both the case and population control groups. This finding needs further studies. The case-control pair analysis did not indicate a teratogenic risk of three parenteral penicillin G treatments during the second-third months of gestation, i.e., in the critical period for major congenital abnormalities. The lower use of penicillins G was explained mainly by recall bias in the population control group. Thus, parenteral penicillin G treatments during pregnancy do not present a detectable teratogenic risk to the fetus.     

Maternal smoking during pregnancy and behavioural characteristics in 2 - 4-month-old infants

The study aimed to assess potential relationship between maternal smoking during pregnancy and behavioural characteristics in 2 - 4-month-old infants. It covered period from 1999 to 2000 and comprised 250 randomly selected, apparently healthy singleton born infants from community setting (129 boys, 121 girls). The mothers were asked to complete the questionnaires addressing infant, maternal, demographic major characteristics with particular emphasis on maternal smoking during pregnancy. To objectively assess behavioural peculiarities of the infants, the mothers were requested to complete the Early Infancy Temperament Questionnaire. Of 250 mothers, 64. women (25.6 %) smoked during pregnancy. The infants of smoking mothers were more often born low birth weight and were also lighter at study; more frequently they were born at earlier gestational age, had lower Apgar score at 5 th minute, were less frequently breast fed at birth and at the time of study. Mothers who smoked during pregnancy were younger, had lower educational level, and less frequently were married. The infants born to smoking mothers had more frequent fussy periods occurring at about the same time of the day, protesting behaviour at face washing and washing in bath, indifferent attitude to the mother when held by new person, extreme reactions (either indifference or much feeling) during diapering and bowel movement, less attention to the parents during parent-infant play activity, and more sensitivity to the wet diaper. They were also characterised by more intensive reactions (displayed more amount of energy regardless of positive or negative behaviour) compared with the babies from the non-smoking group. This association remained after adjustment has been made for major potential confounders, and had a significant "dose-response" effect. Maternal smoking during pregnancy may serve as a risk factor for infant's behavioural deviations.     

No teratogenic effect of prenoxdiazine: a population-based case-control study

The objective of this study was to investigate the human teratogenic potential of oral prenoxdiazine treatment during pregnancy. The analysis of cases with congenital abnormalities and their matched controls without congenital abnormalities was performed in the large population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996. Of the 22,843 pregnant women who had offspring with congenital abnormalities, 158 (0.7%) were treated with prenoxdiazine. Of the 38,151 pregnant women who had babies without any defects in the study period (control group), 226 (0.6%) were treated with prenoxdiazine (adjusted prevalence odds ratio, 1.0; 95% confidence interval, 0.8-1.3). The comparison of cases and their matched controls did not show a significantly higher rate of prenoxdiazine treatment during the second and third months of gestation in the total (adjusted prevalence odds ratio, 1.4; 95% confidence interval, 0.9-2.2) or in any group of congenital abnormalities. Treatment with prenoxdiazine during pregnancy did not have any teratogenic risk to the fetus. Thus, prenoxdiazine treatment in pregnant women with an unproductive cough may be beneficial.     

Effect of intrauterine nutritional deprivation on neuromotor behaviour of the newborn.

The neurological maturation in 25 newborn babies born to severely undernourished mothers was studied by evaluating muscle tone and excitability status. These mothers had weight below the 25th percentile expected for height, haemoglobin less than 80.0 g/l and serum albumin less than 25.0 g/l. Twenty-three babies born to healthy mothers were studied as control. The babies of undernourished mothers demonstrated gross intrauterine growth retardation. There occurred parallel reduction in placental weight and its protein content. The neuromotor behaviour of these newborns showed significant alteration in the performance of most reflexes, resembling normal motor behaviour of preterm infants. As many as 72% newborns could be classified as hypotonic and 56% hypoexcitable. However, no newborn demonstrated hypertonia or hyperexcitability. The parameters of neuromotor assessment were found to have no correlation with the birth weight in both undernourished as well as control group. These observations suggest that muscle tone and excitability are better indices of maturation of central nervous system than the birth weight. It seems that the neurological evaluation becomes unreliable in babies who suffer from intrauterine nutritional deprivation.     

Congenital toxoplasmosis: 10-year follow up

Abstract A long-term follow up was begun in 1982 on offspring of mothers who acquired toxoplasmosis during gestation. The 114 newborns were subdivided into 3 groups: (1) 26 born to mothers with certain infection; (2) 51 born to mothers with probable infection, and (3) 37 born to mothers with doubtful infection. There were five infections in the first group (19.2%), three in the second (5.8%) and none in the third. For purposes of data elaboration we considered only the 77 offspring of mothers with certain or probable infection. Of these, 2 infected cases out of 52 (3.8%) were born to mothers with infection in the first trimester of pregnancy, 4 out of 21 (19%) in the second trimester, and two out of four in the third. There were a total of 8 congenital infections (10.4%). Specific IgM antibodies were revealed in five out of eight infected children (62.5%). Infection was symptomatic in two children (2.6% of newborns at risk, 25% of infected cases), both born to mothers with infection in the second trimester. In the other six cases diagnosis was reached by evaluating trends in antibody levels: the percentage of infected newborns was higher in the group of maternal infections untreated (50%) or improperly treated (15.4%), compared to those receiving adequate treatment (6.9%). We suggest considering as infected children presenting specific IgM antibodies and/or antibody titres which do not become negative, even when symptoms are absent. Therapy with spiramycin should be started in all newborns at risk, while the use of sulphamides and pyrimethamine is justified only after the presence of infection is confirmed.Conclusion Identification of susceptible women before or early in pregnancy would permit adoption of preventive measures aimed at reducing the frequency of congenital infection which is still high in our case series.     

Diabetes mellitus during pregnancy and the risks for specific birth defects: a population-based case-control study

Although the excess risk for birth defects among children of mothers with diabetes mellitus is well documented, there are few data concerning the risk for specific malformations. In the Atlanta Birth Defects Case-Control Study, those risks for malformations were evaluated. The population-based study included 4929 live and stillborn babies with major malformations ascertained by the Metropolitan Atlanta Congenital Defects Program in the first year of life born to residents of Metropolitan Atlanta between 1968 and 1980. The study also included 3029 nonmalformed live babies who were frequency-matched to case babies by race, period of birth, and hospital of birth. The relative risk for major malformations among infants of mothers with insulin-dependent diabetes mellitus (n = 28) was 7.9 (95% confidence interval [CI]1.9, 33.5) compared with infants of nondiabetic mothers. The relative risks for major central nervous system and cardiovascular system defects were 15.5 (95% CI = 3.3, 73.8) and 18.0 (95% CI = 3.9, 82.5), respectively. The absolute risks for major, central nervous system, and cardiovascular system malformations among infants of diabetic mothers were 18.4, 5.3, and 8.5 per 100 live births, respectively. Infants of mothers with gestational diabetes mellitus who required insulin during the third trimester of pregnancy were 20.6 (95% CI = 2.5, 168.5) times more likely to have major cardiovascular system defects than infants of nondiabetic mothers. The absolute risk for infants of this group of diabetic mothers was 9.7%. No statistically significant differences were found among infants of mothers with gestational diabetes mellitus who did not require insulin during pregnancy.(ABSTRACT TRUNCATED AT 250 WORDS)     

EFFECT OF INTRAUTERINE NUTRITIONAL DEPRIVATION ON NEUROMOTOR BEHAVIOUR OF THE NEWBORN

Abstract. The neurological maturation in 25 newborn babies born to severely undernourished mothers was studied by evaluating muscle tone and excitability status. These mothers had weight below the 25th percentile expected for height, haemoglobin less than 80.0 g/l and serum albumin less than 25.0 g/l. Twenty-three babies born to healthy mothers were studied as control. The babies of undernourished mothers demonstrated gross intrauterine growth retardation. There occurred parallel reduction in placental weight and its protein content. The neuromotor behaviour of these newborns showed significant alteration in the performance of most reflexes, resembling normal motor behaviour of preterm infants. As many as 72% newborns could be classified as hypotonic and 56% hypoexcitable. However, no newborn demonstrated hypertonia or hyperexcitability. The parameters of neuromotor assessment were found to have no correlation with the birth weight in both undernourished as well as control groups. These observations suggest that muscle tone and excitability are better indices of maturation of central nervous system than the birth weight. It seems that the neurological evaluation becomes unreliable in babies who suffer from intrauterine nutritional deprivation.     

Hepatitis B Virus Infection in the Infants Born to HBe Antigen Negative Carrier Mothers: A Preliminary Report

One hundred infants born to hepatitis-Be antigen (HBeAg)-negative carrier mothers were followed with or without the administration of hepatitis-B vaccine (HB vaccine) and/or hepatitis-B hyperimmune globulin (HBIG). Among the infants without treatment, 7.6% of the infants born to the antibody-to HBeAg (anti-HBe)-positive carrier mothers and 14% of those born to the carrier mothers without HBeAg and anti-HBe developed HBs-antigenemia, whereas none of the infants treated became positive for HBsAg. The results indicate the necessity for preventive measures for the babies born to HBsAg-carrier mothers, regardless of their HBeAg state.     

INVESTIGATION OF 89 CHILDREN BORN BY DRUG-DEPENDENT MOTHERS I

ABSTRACT. Among 89 infants born by opiate- and methadone-addicted mothers 20% were preterm and 31% were light for gestational age. Mean gestational age. Mean gestational age and birth weight were lower in infants of mothers who had taken mainly opiates compared with infants of mothers who had taken mainly methadone. Preterm labor was more frequent among women who had been acutely withdrawn on methadone within the last month before birth than among women who were maintained on methadone at birth. 85% of the newborns had withdrawal symptoms and 12% had convulsions the severity of which was not correlated with the type of drug abuse. The duration of withdrawal, however, correlated with the amount of methadone taken by the mother at birth. 20% had signs of perinatal asphyxia and had an increased frequency of neonatal convulsions. These babies represent a special high-risk group of newborns. Prevention, therapy and care demand extraordinary combined efforts by politicians, social welfare personnel, midwives, doctors and nurses.