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Babies with AnomaliesA Scottish Overview

Information & Statistics DivisionNational Health Service Scotland

Scottish Programme for Clinical Effectivenessin Reproductive Health

Edinburgh 2001

© Common Services Agency/Crown Copyright 2001

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Babies with Anomalies - A Scottish Overview

pageSummary 5Introduction 7

Aims of the report, Definitions, Data Sources

Section 1 : Babies with Anomalies: the size of the problem 91.1 Scottish Congenital Anomalies Register (SCAR) 91.2 Glasgow Register of Congenital Anomalies 101.3 A six year study of the antenatal detection of fetal abnormality in six Scottish 12

Health Boards1.4 The SNAP report on Cleft Lip and Palate 13

Section 2 : International Comparisons 142.1 United Kingdom 142.2 Europe 14

Section 3 : Babies with anomalies: those who die 17

Section 4: Surviving Babies with Anomalies 214.1 Morbidity among surviving babies 21

Section 5: Maternal antecedents of congenital anomaly 235.1 Maternal Age 235.2 Maternal Obesity 24

Section 6: Antenatal detection of fetal anomalies 25

Section 7: Termination of Pregnancy for Fetal Anomaly 26

References 29

AppendixAcknowledgements 30National Statistics 30


Contents

1. This report provides an overview, based on a range of contemporary data sources, of congenitalanomalies in Scotland. Prevalence and mortality rates for all forms of anomaly are summarised.More detailed information, including measures of morbidity in surviving babies, is provided forthree selected types of anomaly:

• Cardiac anomalies• Cleft lip and palate• Neural tube defects

THE SIZE OF THE PROBLEM2. Overall congenital anomaly rate: estimates vary depending on the data source, reflecting different

inclusion criteria.

• Scottish Congenital Anomalies Register (SCAR) 1988-1994: 900/10,000 births.• Glasgow Register of Congenital Anomalies (EUROCAT) 1990-1994: 270/10,000 births.• Six year study (Smith & Hau) (‘antenatally detectable’ anomalies) 1989-1994: 113/10,000 births.

3. Prevalence of the three selected anomalies: estimates also vary depending on the data source:

• Cardiac: SCAR, 50; Glasgow, 27; Smith & Hau, 19 (all per 10,000 births)• Cleft lip/palate: SCAR, 10; Glasgow, 8 (per 10,000 births)• Neural tube defects: SCAR, 4; Glasgow, 17; Smith & Hau, 7 (all per 10,000 births) (Glasgow and Smith & Hau rates include abortions undertaken for antenatally detected anomalies,SCAR rates do not)

INTERNATIONAL COMPARISONS4. Established networks facilitate the sharing and comparing of data:

• The British Isles Network of Congenital Anomalies Registers (BINOCAR) aims to improve datacollection within the UK. Published overall anomaly rates for England & Wales are around85/10,000 births. This is markedly lower than the published Scottish rates and suggests under-ascertainment.

• European Registration of Congenital Anomalies (EUROCAT) includes centres in 15 Europeancountries. The overall, major anomaly rate (1990-’94) was 227/10,000 (range among individualcentres, 99-361/10,000). The Glasgow Registry had the highest rates of both neural tube defectsand cleft palate.

THOSE WHO DIE5. The major (lethal) malformation rate in 1999, based on the Scottish Stillbirth & Infant Death

Survey, was 12.8/10,000 births. 6. Anomalies accounted for 9.7% of all stillbirths, 31.3% of all neonatal deaths and 26.2% of all

postneonatal infant deaths over the 15 years,1985-1999.

SURVIVING BABIES WITH ANOMALIES7. Survival: data from SCAR (1988-’94) demonstrate, for the three selected categories of anomaly, the

percentage of those affected who survived until their first birthday:

• Cardiac: approx. 75%• Cleft lip/palate: approx. 93%• Neural tube defect: approx. 70%

8. Health service utilisation: ISD’s linked database has provided information on hospital admissions.During the first year of life, the average number of inpatient ‘bed days’ utilised by babies with theselected anomalies were as follows:

• Cardiac: 32 bed days per baby• Cleft lip/palate: 11 bed days per baby• Neural tube defect: 33 bed days per baby

Babies with Anomalies - A Scottish Overview 5

Summary

MATERNAL ANTECEDENTS9. The well-documented increase in chromosomal anomalies with increasing maternal age is

confirmed by our Scottish data. We are unable to confirm the ‘U’-shaped relationship between non-chromosomal anomalies and maternal age reported by others.

ANTENATAL DETECTION10. Data from the six-year study of Smith & Hau (1989-1994) demonstrate that, of anomalies considered

to be detectable antenatally given ideal circumstances, 62% were detected in practice. Amongwomen who underwent a detailed scan at 20-22 weeks, the detection rate of nine potentiallydetectable structural abnormalities was 92%. Cardiac anomalies were less frequently detected (egonly 24% of hypoplastic left ventricle). The detection rate for spina bifida was 76%. (Cleft lip/palatewas excluded from this study.)

TERMINATION FOR FETAL ANOMALY11. Abortions for antenatally detected anomalies comprise only around 1% of all abortions.

Babies with Anomalies - A Scottish Overview6

This is the third volume in the Births in Scotland series, published jointly by the ScottishProgramme for Clinical Effectiveness in Reproductive Health (SPCERH) and the Information &Statistics Division of NHSScotland (ISD). The aim of this biennial series is to explore importantclinical topics in the perinatal field using information routinely collected by ISD through SMR02and related datasets. The content of the publications is overseen by a multi-professionalcommittee, the Scottish Perinatal Mortality & Morbidity Review Advisory Group (SPMMRAG).It is anticipated that these overviews will be relevant and useful to all professionals who sharein maternity and perinatal care in Scotland.

Congenital anomalies often cause, or are associated with, stillbirth and infant death. Two inevery 1000 babies born will die of a congenital anomaly before the age of one year; andanomalies account for a fifth of all stillbirths and infant deaths. Less easy to quantify are thenumbers of babies born with anomalies who survive infancy - and the impact of their anomalieson quality of life for the infants themselves and for their families. The importance of congenitalanomaly as a cause of infant mortality and morbidity persists despite a range of healthcaremeasures specifically designed to reduce the incidence of malformed babies. Such measuresinclude universal guidance on folic acid intake, serum screening for Down’s syndrome / neuraltube defects and detailed ultrasound scanning for detection of anomalies.

When using perinatal mortality rates as measures of the quality of health services, it isconventional to exclude mortality due to anomalies from consideration - on the basis that suchmortality is ‘unavoidable’1. Nevertheless, the rate of congenital anomaly at birth should bereducible, at least in part, through the adoption of the sorts of healthcare measures mentionedabove. Because it is a major, but often ignored, contributor to perinatal and infant mortality andmorbidity and because of the wealth of relevant data available to us in Scotland, the SPMMRAGfelt that the topic of Babies with Anomalies was an appropriate choice for this third Births inScotland volume.

Aims of the Report

This report aims to provide an overview, based on a range of data sources, of the prevalence of,and mortality due to, all forms of congenital anomaly. In addition, three specific categories ofanomaly have been chosen for more detailed study. The selected anomalies are:

• Congenital heart disease • Cleft lip and palate • Neural tube defects

(including anencephaly and spina bifida but excluding spina bifida occulta)

These were chosen as representing a spectrum of anomalies, differing in the potential forprevention, early identification, postnatal treatment and likelihood of survival. For theseanomalies, an attempt has been made to quantify morbidity and health service utilisation ininfancy, through the use of linked ISD datasets.


Introduction

Definitions

The Scottish Stillbirth & Infant Death Survey uses the following definition of ‘congenitalanomaly’: any genetic or structural defect arising at conception or during embryogenesis incompatiblewith life or potentially treatable but causing death. Using this definition, renal agenesis, for example,is clearly a congenital anomaly whereas pulmonary hypoplasia, arising secondary tooligohydramnios, is not. In this report, discussion relating to anomalies causing the death of theinfant is in line with this definition.

Defining a congenital anomaly in a surviving infant is more problematic, but the GlasgowRegister of Congenital Anomalies seeks to record all anatomical, metabolic and genetic congenitalanomalies identified by a doctor, midwife or health visitor. Certain minor defects such as umbilical andinguinal herniae, preauricular appendages, tongue tie and occult spina bifida are specificallyexcluded.

The information included in this Report, both on overall congenital anomaly rates and on thethree selected types of anomaly, is derived from a number of different sources. Definitions andinclusion criteria vary from source to source. For example, some data on ‘neural tube defects’include anencephaly, whereas others include only spina bifida.This must be borne in mind wheninterpreting the information.

Data Sources• Scottish Stillbirth & Infant Death (SSBID) Survey*, 1985 - 1999 (11,087 infants)• Scottish Congenital Anomalies Register (SCAR)*,1988 - 1994 (42,000 cases)• Scottish Morbidity Record (SMR01)*,1988 - 1992 (data on admissions relating to selected

anomalies)• A six year study of the antenatal detection of fetal abnormality in six Scottish Health Boards

Smith NC, Hau C.2 (a study undertaken between 1989 and 1994 under the auspices ofSPMMRAG)

• Glasgow Register of Congenital Anomalies (maintained by Greater Glasgow HealthBoard) 1988-1998 (3,885 infants)

• Notifications to the CMO for Scotland of terminations of pregnancy under the AbortionAct* 1980-1999

* Figures contained in this publication, which are derived from the sources marked with an *, areNational Statistics (see Appendix). Figures derived for the other sources are outwith the scope ofNational Statistics.


1.1 Scottish Congenital Anomalies Register (SCAR)

Between 1988 and 1994, ISD maintained a robust Scottish Congenital Anomalies Register(SCAR). The aim was to register all congenital anomalies detected at birth or in infancy. Datawere obtained from neonatal returns (SMR11), from the Stillbirth & Infant Death Survey andfrom returns relating to hospital admissions in the first year of life (SMR01). These datasets werelinked to permit the identification of duplicates. In practice, 80% of all identified anomalies wererecorded in SMR11. SCAR did not include data on abortions undertaken because of antenatallydetected anomalies.

The reliability of SCAR has declined over time, especially since 1996, when the routinecompletion of an SMR11 return for all babies was discontinued. For the purposes of this Reporttherefore, we are presenting Scottish prevalence rates based on data collected between 1988 and1994. Currently, plans are well advanced within ISD for the re-instatement of an SMR11 for allbabies. This move is welcomed by SPMMRAG and will facilitate data collection for futurereports such as this.

As Table 1.1 shows, each year, almost one in every ten babies born had some form of registeredanomaly. It should be noted, however, that all documented anomalies were included in SCAR.No steps were taken to exclude anomalies of minimal significance and many of the anomaliesincluded in the total would fall into this category. The anomalies chosen for special study in thisReport represent a relatively small proportion of the overall total:

• Overall aomaly rate approx. 900/10,000 births• Cardiac anomalies approx. 50/10,000 births• Cleft lip ± palate approx. 10/10,000 births• Spina bifida approx. 4/10,000 births

Table 1.1Number of births and congenital anomalies - Scotland:Selected diagnosis by year; 1988-1994


Section 1 Babies with anomalies: the size of the problem

Year

Diagnosis 1988 1989 1990 1991 1992 1993 1994

Number of births 66576 64961 63712 65935 66708 64437 62762

Number

Number of Cases on Register 6074 5936 5811 5988 6133 6335 5740Spina bifida +/- Hydrocephalus 37 30 25 28 20 20 21Anomalies of the eye 36 42 61 75 62 90 89Anomalies of the Heart 283 266 265 292 341 331 318Cleft Palate 36 52 59 41 49 40 48Cleft Lip +/- Cleft Palate 71 52 63 64 80 51 50Reduction deformaties of the limbs 22 24 18 32 25 21 25Exomphalos and Gastroschisis 23 17 26 23 19 18 29Downs Syndrome 76 58 67 77 50 49 58Multiple congenital anomalies 45 47 55 60 57 61 57

Rate per 10,000 live births

Number of Cases on Register 912.3 913.8 912.1 908.2 919.4 983.1 914.6Spina bifida +/- Hydrocephalus 5.6 4.6 3.9 4.2 3.0 3.1 3.3Anomalies of the eye 5.4 6.5 9.6 11.4 9.3 14.0 14.2Anomalies of the Heart 42.5 40.9 41.6 44.3 51.1 51.4 50.7Cleft Palate 5.4 8.0 9.3 6.2 7.3 6.2 7.6Cleft Lip +/- Cleft Palate 10.7 8.0 9.9 9.7 12.0 7.9 8.0Reduction deformaties of the limbs 3.3 3.7 2.8 4.9 3.7 3.3 4.0Exomphalos and Gastroschisis 3.5 2.6 4.1 3.5 2.8 2.8 4.6Downs Syndrome 11.4 8.9 10.5 11.7 7.5 7.6 9.2Multiple congenital anomalies 6.8 7.2 8.6 9.1 8.5 9.5 9.1

Source: Scottish Congenital Anomaly Register and ISD Scotland (SMR02)

1.2 Glasgow Register of Congenital Anomalies

This Register is an additional source which provides a guide to the prevalence of congenitalanomalies in Scotland. The Glasgow Register was founded in 1972 under the auspices of theSocial Paediatric and Obstetric Research Unit and was adopted by the Greater Glasgow HealthBoard in 1974. In 1980, The Glasgow Register became one of the participating centres in theBrussels-based European Register of Congenital Anomalies and Twins (EUROCAT) project.

The reference population comprises all births to women resident in the GGHB area (around12,000 annually) regardless of the place of birth. Live births, stillbirths, miscarriages and thoseinduced abortions which follow antenatal diagnosis of an anomaly are all included. Allanatomical, metabolic and genetic anomalies are eligible for registration, with specific exclusionsof minor anomalies, in line with EUROCAT definitions. Multiple sources of ascertainment areemployed, with no time limit for registration. These sources comprise:

• Hospital discharge data (SMR1, SMR2, SMR11)• Child Health Surveillance Programme• Stillbirth / Death registration• Medical genetics and post-mortem reports• Phenyl ketonuria / hypothyroidism screening• Immunisation consent forms

Routine analysis of the Glasgow data consists of the generation of annual birth prevalence rates(the number of affected infants per 10,000 total births in a given year) for all defects and for 15categories defined by EUROCAT. Because there is no time limit for registration, anomaliesdetected at any stage of life can be added to the birth prevalence figures for an individual’s yearof birth. In addition, ad hoc analyses are performed in accordance with local needs and interests.

Over the period 1980-1986, the overall anomaly rate calculated from the Glasgow Register was339/10,000 births3. A more recent estimate (1990-1994) published by EUROCAT6 was 272/10,000births. (Since publication of the EUROCAT Report, this figure has been updated to 302/10,000,reflecting ascertainment of additional cases some time after birth.) These estimates are clearlylower than the overall rate of around 900/10,000 births calculated from SCAR. This differencemay be due to the exclusion of defined categories of minor anomalies from the Glasgow Register.

Table 1.2 summarises rates of our three selected categories of anomaly for the period 1988-1998as calculated from the Glasgow Register. The overall rates were:

• Cardiac anomalies 27/10,000 births (4% ascertained from abortion data)• Cleft lip 8/10,000 births (1% ascertained from abortion data)• Spina bifida 18/10,000 births (69% ascertained from abortion data)

The rate for cleft lip is of the same order as the SCAR rate - this is consistent with these anomaliesbeing easily identifiable at birth and seldom resulting in termination of pregnancy. Cardiacanomalies are considerably lower than in SCAR, perhaps because minor, often functional,murmurs, later found to have been of no significance, were included in the Scottish Register. Therate of neural tube defects is higher in the Glasgow register than in SCAR. However, theGlasgow rate of spina bifida is 5.3/10,000 if cases registered on the basis of miscarriage/abortionare excluded. This is of the same order as the SCAR rate, which does not include abortion data.


Table 1.2GREATER GLASGOW HEALTH BOARD - CONGENITAL ANOMALIES REGISTERSELECTED ANOMALIES - PRIMARY ANOMALY 1988 - 1998


Heart Cleft Palate

Year Live Still TOP/SA 2 Total Rate 3 Live Still TOP/SA 2 Total Rate 3

births births births births1988 34 1 1 36 27.9 7 0 0 7 5.41989 36 0 0 36 29.3 7 0 0 7 5.71990 33 0 0 33 26.5 5 0 0 5 4.01991 30 1 1 32 24.9 9 1 0 10 7.81992 34 2 1 37 30.0 10 0 0 10 8.11993 29 1 0 30 25.2 5 0 0 5 4.21994 24 2 1 27 23.7 6 0 0 6 5.31995 40 1 3 44 39.3 5 0 0 5 4.51996 28 0 1 29 26.2 6 0 0 6 5.41997 29 1 4 34 30.9 5 0 0 5 4.51998 11 1 2 14 13.5 13 0 1 14 13.5

Total 328 10 14 352 27.1 78 1 1 80 6.2

Cleft Lip Neural Tube

Year Live Still TOP/SA 2 Total Rate 3 Live Still TOP/SA 2 Total Rate 3

births births births births1988 10 0 0 10 7.7 9 0 12 21 16.31989 6 0 0 6 4.9 6 1 20 27 22.01990 8 0 0 8 6.4 3 1 17 21 16.81991 8 0 0 8 6.2 5 1 13 19 14.81992 12 0 0 12 9.7 4 1 15 20 16.21993 7 1 1 9 7.6 4 2 13 19 16.01994 8 0 0 8 7.0 8 0 13 21 18.41995 9 0 0 9 8.0 3 5 12 20 17.91996 10 0 0 10 9.0 6 1 22 29 26.21997 15 0 0 15 13.6 1 2 8 11 10.01998 8 0 1 9 8.7 5 1 14 20 19.3

Total 101 1 2 104 8.0 54 15 159 228 17.6

1 1997/1998 Figures Provisional2 TOP = Termination of Pregnancy; SA = Spontaneous Abortion3 Rate per 10,000 live and still births

Source: Glasgow Register of congenital Anomalies Registrar General (Scotland) Annual Reports

1.3 A six year study of the antenatal detection of fetal abnormality in six Scottish health boards

Between 1989 and 1994, meticulous, prospective data collection was used to identify allanomalies ‘considered detectable by prenatal diagnosis’. This study therefore specificallyexcluded isolated cleft lip, clubfoot and ventricular septal defect. Identified cases included bothterminations for fetal anomaly and babies born with an anomaly. Within these limits, this studyprobably provides the most accurate available estimate of the birth prevalence of significantanomalies in Scotland.

The six year study was undertaken under the auspices of SPMMRAG, with Dr NC Smith actingas principal investigator. The findings have been published in full in the British Journal ofObstetrics & Gynaecology 2. The principal objective of the study was to assess the sensitivity ofprenatal diagnosis by ultrasound and biochemical methods and to evaluate the reasons for non-detection. Meeting this objective required that ‘detectable’ anomalies be accurately quantified.The birth prevalence of detectable anomalies was found to be 113/10,000 (2985 of 264,481deliveries). This rate is considerably lower than overall rates based on SCAR or GlasgowRegister data (900/10,000 and 340/10,000 respectively). This discrepancy is explained by thestrictly defined categories of anomaly included in the six year study and also because thepublished results relate to singleton pregnancies only.

Of our three selected categories of abnormality, cleft lip/palate was specifically excluded fromthe six year study as it was not considered detectable prenatally. The overall rate of ‘detectable’cardiac anomalies was 19/10,000 births and of spina bifida was 7/10,000 births. These rates areof the same order as those based on the Glasgow Register.

Table 1.3Summary of rates of anomaly derived from three different sources(all rates expressed per 10,000 births)

Data Source Overall Cardiac Clefting NTD

Scottish Congenital Anomalies Register (SCAR) 900 50 10 4

Glasgow Register of Congenital Anomalies 340 27 8 17

Six-year study 110 19 N/a 7


1.4 The SNAP Report on Cleft Lip and Palate

In November 1998, the Scottish Needs Assessment Programme (SNAP) commissioned a reporton cleft lip and palate4. This report was developed by a small working group chaired by GrahamBall (consultant in dental public health). The aim of the SNAP report was to provide guidancefor those commissioning services related to cleft lip and palate. The report included a usefuloverview of the ‘size of the problem’ in Scotland which is summarised here.

1. For over 50 years, investigators have carried out birth prevalence studies on patients withcleft lip and palate. From these studies, the average birth prevalence of facial clefting incaucasian populations is 10/10,000 total births for cleft lip and 5/10,000 for cleft palatealone.

2. Data from SCAR allow cases of cleft lip and palate among babies born between 1988 and1995 to be presented on a regional basis. Cases are divided into six regions based on thesix centres currently providing cleft lip and palate treatment in Scotland.

Table 1.4Cleft lip and palate, workload by region from SNAP Report (1998)

Region 1988 1989 1999 1991 1992 1993 1994 1995

Glasgow 35 38 33 42 57 35 38 35

Edinburgh 29 25 32 24 38 24 28 31

Aberdeen 17 11 19 14 15 15 18 6

Dundee 8 6 12 12 7 8 13 14

Ayr 9 7 8 8 4 7 9 8

Falkirk 9 9 2 4 7 6 4 7

TOTAL 107 96 106 104 128 95 110 101

3. In 1989, a project was initiated by the cleft teams in these Scottish centres to produce anational registry and database. This became known as the Scottish Association for CleftLip and Palate (SCALP) registry and database. The aim of this registry is to provide avalidated database of all children born with syndromic and non-syndromic clefts inScotland. In addition, data collection protocols have been devised for each specialty - cleftsurgery, orthodontics, speech and language therapy and audiology so that consistent andco-ordinated records will be available for audit and research.

4. Based on an overall birth prevalence of 1:700, there are probably well in excess of 7000people in Scotland who have had some form of orofacial clefting. A small proportion ofthese will be adults who have had no treatment, or rudimentary treatment, and who mayrequire ongoing intervention from any of the cleft specialties.


Section 2 International Comparisons

2.1 United Kingdom

England and Wales have had a national monitoring system for congenital anomalies since 1964.This system was established in the wake of the thalidomide disaster and is administered by theOffice for National Statistics (ONS). Registration is voluntary and linked to birth notification, sodata are unlikely to be complete and anomalies detected some time after birth may not beincluded. ONS have adopted a defined list of conditions for exclusion, which matches theEUROCAT recommendations.

Over the past decade, the overall anomaly rate calculated by ONS has been around 85/10,000births. This rate is less than the SCAR rate by an order of 10. This suggests that ascertainment bythe English system may be very poor. Indeed, comparison with a separate, specialist registersuggests that half of cases of Down’s syndrome may escape registration with ONS 5.

For our selected anomalies, recorded rates for E&W over the past decade have averaged ataround:

• Cardiac anomalies 8 /10,000 births• Cleft lip 6 /10,000 births• Spina bifida 1 /10,000 births

As for, the overall anomaly rate, all these rates are lower than those calculated from SCAR whichemphasises the likelihood of incomplete data collection in England & Wales.

BINOCAR (British Isles Network of Congenital Anomaly Registers) was set up jointly, in 1996,by ONS and Dr David Stone at the Glasgow Register of Congenital Anomalies. The purpose ofthe network is to bring together all those working in the field of monitoring and reporting oncongenital anomalies.

Since 1964 the National Congenital Anomaly System (NCAS) at ONS has monitored thenumbers of congenital anomalies reported by English and Welsh health authorities. In recentyears registers have also been set up in some regions to collect cases of congenital anomalies.Some registers focus on prenatal diagnosis and counselling, others are part of epidemiologicalstudies. Registers collecting cases of specific anomalies such as Down Syndrome and facial cleftshave also been set up. All these registers are part of the BINOCAR network.

2.2 Europe

EUROCAT (European Registration of Congenital Anomalies) was established in 1979 as one ofthe first Concerted Action Research Programmes funded by the European Commission. Themain objectives were to detect and investigate trends in the frequency of congenital anomaliesthat could be due to environmental teratogens or mutagens. A report published in 1997summarised 15 years of surveillance in 12 EC countries and three additional non-member states6.The following key points are taken from the Summary of that report:

• A total of 4,346,727 births were surveyed.• The prevalence of major congenital anomalies (based on data from 16 selected

centres) was 236 per 10,000 births.• At the start of the 15 year period, the prevalence of neural tube defects was two to

three times higher in the UK and Irish centres compared with the rest of Europe.Over time, the rate declined in these centres (from 40 to 10-15 per 10,000) resulting inrates close to continental centres.


• Among centres, overall rates of Down’s syndrome range from 11.5-23.0/10,000; ratesamong mothers aged >=35 years range from 35.7-93.6/10,000 and rates amongmothers aged <30 years range from 5.2-11.2/10,000. These differences can beexplained by differences in maternal age distribution and in provision and uptake ofprenatal diagnosis.

Table 2.1 summarises the overall prevalences of major anomalies (based on live births, fetaldeaths from 20 weeks and induced abortions following antenatal diagnosis) for 16 selectedcentres following EUROCAT methodology. Differences in rates of anomaly among centres arevery apparent and may, at least in part, be attributable to differences in ascertainment - despitethe fact that all these registries endeavour to follow EUROCAT methodology.

Table 2.1Prevalence rate (per 10,000 births) in 16 EUROCAT registries, 1990-1994

REGISTRY MAJOR CARDIAC CLEFT CLEFT LIP NTDANOMALIES PALATE +/- PALATE

Glasgow (UK) 272.3 63.3 9.4 8.7 15.9

Belfast (UK) 98.8 28.9 2.5 3.3 10.0

Galway (Irl) 199.9 27.9 5.4 6.2 14.7

Dublin (Irl) 240.0 52.1 7.5 8.8 14.2

Odense (Dk) 208.7 67.4 7.8 12.9 9.1

N. Netherlands 219.4 64.9 7.2 15.3 11.3

Antwerp (B) 252.5 50.2 3.0 10.0 10.0

Hainaut-Namur (B) 270.1 84.4 7.5 12.6 11.2

Paris (F) 360.8 47.9 6.2 9.7 12.2

Strasbourg (F) 349.4 98.2 8.8 12.5 10.1

Bouches-du-Rhone (F) 227.5 61.7 8.6 7.4 11.0

Switzerland 162.3 45.9 6.5 8.7 5.6

Tuscany (I) 216.2 60.7 4.3 8.2 6.6

Basque Country (E) 215.1 50.1 4.9 5.5 11.0

Asturias (E) 218.8 49.0 6.3 8.2 13.9

Malta 198.7 38.4 8.4 6.5 9.2

TOTAL 227.1 54.3 6.4 8.9 10.1

Cardiac anomaliesComparative data on rates of cardiac anomalies were not included in the EUROCAT Report6 buthave been provided for inclusion in Table 2.1 by the EUROCAT administration at the LondonSchool of Hygiene & Tropical Medicine. The Glasgow rate of 63.3/10,000 births is similar to thatof the other centres, though higher than the average.

Cleft lip & palateThese anomalies are among selected categories for which time trends and regional variationswere presented in the EUROCAT Report6. For these anomalies, the Glasgow rates are similar tothose from the other registries, with no clear time trend. Table 2.1 includes the 1990-1994 ratesfor these two categories of anomaly.

Neural Tube DefectsNTDs are also among selected anomalies for which time trends and regional variations werepresented in the EUROCAT Report6. As indicated in the summary above, the UK/Ireland


registries show the highest rates of NTD, but, over the 15 year time period, rates have fallen andare now similar to the rest of Europe. Table 2.1 shows the aggregate prevalence rates for 1990-1994 for the 16 registries following EUROCAT methodology.

Figure 2.2 (reproduced from the EUROCAT Report6) shows the fall in prevalence of spina bifidaover time in the Glasgow, Belfast and Dublin Registries with rates in illustrative EuropeanRegistries (Paris and N.Netherlands) shown for comparison.

Figure 2.2Spina Bifida: prevalence rate (per 10,000 births per year) in selected EUROCATregistries, 1980-1994.

GLASGOW BELFAST

DUBLIN PARIS

NORTH NETHERLANDS


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A ‘major malformation rate’ is published annually as part of the Scottish Stillbirth & Infant Death(SSBID) Report. This rate is based on babies weighing ≥500g at birth and represents the numberof stillbirths and infant deaths classified as due to congenital anomaly per 1000 total births.Major malformation rates calculated on this basis over the past 15 years are summarised inFigure 3.1. The major malformation rate in 1999 was 1.28/1000 (12.8/10,000), the lowest raterecorded over this time period.

Figure 3.1 also shows the trend in abortions undertaken because of detected fetal anomaly overthe same time period. The fall in stillbirths and infant deaths with major malformations in recentyears has been accompanied by a rise in abortions performed because of fetal anomaly.

Figure 3.1Major (lethal) malformation rates based on SSBID data and abortion data(rates per 1000 births + abortions) 1989 - 1999

During the 15-year period 1985-1999, a total of 11,087 stillbirths and infant deaths were reportedto the Scottish Stillbirth and Infant Death Survey (SSBIDS). Of these deaths, 2266 (20.4%) wereclassified as being due to a congenital anomaly. Over the 15 years, deaths attributed to congenitalanomaly ranged from 18.1% to 22.8%. Overall, 9.7% of stillbirths, 31.3% of neonatal deaths and26.2% of postneonatal deaths were attributed to congenital anomaly. The percentages of eachcategory of death attributed to anomalies year on year are summarised in Figure 3.2. For stillbirths and neonatal deaths, the proportions attributable to anomalies have changed littleover the time period. The proportion of postneonatal infant deaths in the congenital anomaly


Section 3 Babies with Anomalies: those who die

Source: Scottish Stillbirth and Infant Death Survey and Notiications, to the chief MedicalOfficer for Scotland, of terminations of pregnancy under the Abortion Act 1967

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

19991998199719961995199419931992199119901989

Years

Rat

es

terminations

sbid

total

category rose sharply between 1991 and 1992 (from around 20% to over 30%). This changereflects the sharp fall in deaths from Sudden Infant Death Syndrome which is recorded as havingbegun around November 1990 (1993 SSBID report).

More detailed information on the contribution of congenital anomalies to all deaths over time issummarised in Tables 3.4 and 3.5.

Figure 3.2Percentage of all stillbirths, neonatal and postneonatal deaths with a congenitalanomaly 1985 - 1999

Figure 3.3 shows the timetrend of rates of lethal congenital anomaly for each category of deathstudied within the SSBIDS.

Figure 3.3Stillbirths, neonatal and postneonatal death congenital anomaly rates 1985 - 1999


0.0

4.5

9.0

13.5

18.0

22.5

27.0

31.5

36.0

40.5

45.0

199919981997199619951994199319921991199019891988198719861985

Years

Per

cen

tag

e Stillbirths

Postneonatal deaths

Neonatal Deaths

Stillbirth rate

Neonatal rate

Postneonatal rate

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

19991998199719961995199419931992199119901989198819871986

Years

Rat

e p

er 1

000

tota

l bir

ths

Source: Scottish Stillbirth and Infant Death Survey


Table 3.4Stillbirths, neonatal and postneonatal deaths 1985-1999 - Number and percentage witha congenital anomaly


All Deaths1 Stillbirths

Year Total Congenital anomaly Total Congenital anomalyNumber % Number %

1985 - - - 358 34 9.51986 951 182 19.0 381 38 10.01987 899 185 20.6 338 40 11.81988 898 192 21.4 355 29 8.21989 868 165 19.0 316 16 5.11990 856 157 18.3 349 26 7.41991 840 173 20.6 369 43 11.71992 806 184 22.8 356 34 9.61993 821 185 22.5 409 36 8.81994 762 168 22.0 380 44 11.61995 772 154 19.9 397 35 8.81996 746 151 20.2 381 34 8.91997 635 142 22.4 319 43 13.51998 671 126 18.8 351 38 10.81999 562 102 18.1 286 27 9.4

Total 11087 2266 18.1 5345 517 9.4

Neonatal Deaths Postneonatal Deaths

Year Total Congenital anomaly Total Congenital anomalyNumber % Number %

1985 353 115 32.6 - - -1986 335 102 30.4 235 42 17.91987 315 92 29.2 246 53 21.51988 302 113 37.4 241 50 20.71989 301 95 31.6 251 54 21.51990 288 88 30.6 219 43 19.61991 291 94 32.3 180 36 20.01992 304 101 33.2 146 49 33.61993 254 99 39.0 158 50 31.61994 245 71 29.0 137 53 38.71995 241 71 29.5 134 48 35.81996 233 70 30.0 132 47 35.61997 189 58 30.7 127 41 32.31998 206 49 23.8 114 39 34.21999 182 47 25.8 94 28 29.8

TOTAL 4039 1265 31.3 2414 633 26.2


Table 3.5Trends over time of deaths due to each of the 7 classes of anomaly

Stillbirths and Neonatal deaths due to congenital anomaly:by type of anomaly and year 1985-1999


YEAR

Stillbirths 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 Total

Central Nervous System 14 15 14 7 7 5 7 9 11 16 10 6 13 7 7 148

Cardiovascular System 2 2 3 1 2 2 4 1 3 4 1 2 3 3 1 34

Renal 2 - - 4 - 2 1 1 5 3 2 1 5 - 2 28

Alimentary 1 1 1 1 - 1 - - - - - 1 - 3 - 9

Chromosomal 3 6 13 3 2 5 16 7 11 11 12 8 14 18 8 137

Biochemical 1 - - - - - - - - - - - - - - 1

Other 11 14 9 13 5 11 15 16 6 10 10 16 8 7 9 160

Total 34 38 40 29 16 26 43 34 36 44 35 34 43 38 27 517

Neonatal Deaths

Central Nervous System 23 15 8 14 7 5 9 8 4 1 3 4 5 2 2 110

Cardiovascular System 28 26 17 25 28 30 32 26 29 24 15 25 18 19 10 352

Renal 13 14 8 9 11 7 7 18 15 3 12 5 7 4 5 138

Alimentary 6 4 3 5 2 - 4 1 1 - 1 1 - 4 1 33

Chromosomal 17 10 11 15 13 10 8 13 19 10 14 12 10 7 10 179

Biochemical 1 1 1 1 3 1 2 2 2 4 6 2 1 2 2 31

Other 27 32 44 44 31 35 32 33 29 29 20 21 17 11 17 422

Total 115 102 92 113 95 88 94 101 99 71 71 70 58 49 47 1265

Postneonatal deaths due to congenital anomaly (information on class of anomaly unavailable):

Postneonatal Deaths 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 Total

Congenital - 42 53 50 54 43 36 49 50 53 48 47 41 39 28 633


One of our aims in producing this report was to examine morbidity among babies born withanomalies who survive the neonatal period. The SCAR dataset has enabled us to identify babiesborn with an anomaly who have survived the first year of life. Table 4.1 shows the percentage ofbabies born with each of our selected anomalies who survived beyond their first birthday.

Table 4.1Number and percentage of babies born with selected anomalies who survive beyondtheir first birthdays: 1988 - 1994

4.1 Morbidity among surviving babies

Using ISD’s linked dataset, we have examined hospital utilisation during the first year of lifeamong babies born with our selected anomalies. Table 4.2 below is based on information fromthe linked dataset. For each type of anomaly:

• ‘Patients’ represent the number of infants aged <1year who had at least one hospitaladmission associated with one of the ICD-9 codes indicated.

• ‘Episodes’ represent the total number of hospital episodes experienced by thosebabies during the first year of life.

• ‘Continuous inpatient stays’ are derived by aggregating those ‘Episodes’ whichactually formed part of a single spell of inpatient treatment.

• ‘Length of stay’ represents the total number of bed days experienced by theidentified babies during their first year.

In summary, Table 4.2 shows the following:

• Over the eight-year period, 1,426 babies experienced inpatient stays because of heartanomalies; these babies had a total of 45,067 bed days, or 32 per baby.

• Similarly, 674 infants were admitted with cleft lip/palate; these had a total of 7,414bed days, or 11 per baby.

• 178 babies had inpatient care for neural tube defect; these babies had a total of 5,937bed days, or 33 per baby.


Section 4 Surviving babies with anomalies

1988 1989 1990 1991 1992 1993 1994

Cardiac Total born 283 266 265 292 341 331 318

anomalies Survived to 1yr 218 185 198 217 264 253 252

%survived 77% 69% 75% 74% 77% 76% 79%

Cleft lip / Total born 107 96 106 104 128 90 98

palate Survived to 1yr 97 88 98 96 120 82 93

%survived 91% 92% 92% 92% 94% 91% 95%

Neural Total born 49 42 37 43 30 31 33

Tube Survived to 1yr 34 29 29 34 20 19 24

Defect %survived 69% 69% 78% 79% 67% 61% 73%Source: Scottish Congenital Anomaly Register and ISD Scotland (SMR02)

Table 4.2Congenital Anomalies in Children Under the Age of One


Year of birth

Type of anomaly 1988 1989 1990 1991 1992 1993 1994 1995

Heart1 Patients 174 180 168 200 165 186 175 178

Episodes 501 597 467 592 491 684 696 660

CIS4 285 340 288 340 279 377 351 354

LOS5 4986 6419 5391 5975 5469 5813 5274 4314

Open neural tube2 Patients 27 24 25 28 17 18 21 18

Episodes 52 62 65 79 67 49 63 31

CIS4 43 54 46 65 50 30 52 30

LOS5 934 708 900 986 547 718 737 407

Cleft lip/palate3 Patients 80 70 85 90 109 76 89 75

Episodes 129 122 148 148 184 140 175 126

CIS4 123 112 131 140 176 102 142 118

LOS5 928 1052 1124 932 1269 794 753 562

Notes

1. ICD-9 745, 746 Source: ISD linked database

2. ICD-9 740, 741, 742.0 Date: June 2000

3. ICD-9 749.0, 749.1, 749.2

4. Continuous Inpatient Stays:

A Continuous Inpatient Stay (CIS) is defined as all the SMR records referring to the same continuous spell of inpatient treatment(whether or not this involves transfer between hospitals or even between Health Boards). CIS’s are built up by examining theintervals between successive linked records for a given patient. Thus for each interval a decision is made as to whether the recordsconstitute part of a continuous stay according to defined rules. Apart from the length of interval between two records, decisionshinge on whether the type of discharge of the first record or type of admission of the second record is a transfer.

5. Length of Stay (LOS) - total number of bed days

5.1 Maternal Age

Croen & Shaw7 reported that ‘the distribution of prevalences of all non-chromosomalmalformations was U-shaped across maternal age’. Figure 5.1 and Table 5.2 (below) are based ondata from the SSBID survey (1985-1999) and summarise the rates of chromosomal, non-chromosomal and all lethal congenital anomalies among women in different age groups. Thesedata confirm the well-documented increase in chromosomal anomalies with increasing maternalage. The ‘U’-shaped relationship described by Croen and Shaw for non-chromosomal anomaliesis not convincingly demonstrated by these Scottish data.

Figure 5.1Prevalence of lethal congenital anomalies by maternal age (SSBID 1985-1999)


Section 5 Maternal antecedents of congenital anomaly

chromosomal

non chromosomal

all

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

45+40-4435-3930-3425-2920-2415-19

Maternal Age

Rat

e p

er 1

000

bir

ths

Source: Scottish Stillbirth and Infant Death Survey ISD Scotland (SMR02)

Table 5.2Stillbirths and neonatal deaths with congenital anomalies;by age of mother and year, split by chromosomal/non-chromosomal 1985 - 1999

5.2 Maternal Obesity

Waller et al8 reported that the offspring of obese women (but not underweight women) are at anincreased risk of neural tube defects and several other malformations. It was not possible toexplore this putative association using the Scottish dataset as maternal weight is not collectedwithin the SMR02 system.


Stillbirths

15-19 20-24 25-29 30-34 35-39 40-44 45+ nk Total

Chromosomal 8 22 30 40 21 15 1 - 137

Rate 0.1 0.1 0.1 0.2 0.3 1.4 2.4 - 0.1

Non-Chromosomal 45 86 110 89 34 11 - 5 380

Rate 0.6 0.4 0.3 0.4 0.5 1.0 0.0 - 0.4

Total 53 108 140 129 55 26 1 5 517

Rate 0.7 0.5 0.4 0.6 0.7 2.4 2.4 - 0.6

Total births 79279 222841 322632 223089 74342 10826 419 - 933751

Neonatal Deaths

15-1 20-24 25-29 30-34 35-39 40-44 45+ nk Total

Chromosomal 11 27 52 44 31 7 1 6 179

Rate 0.1 0.1 0.2 0.2 0.4 0.7 2.4 - 0.2

Non-Chromosomal 88 272 371 239 66 14 1 35 1086

Rate 1.1 1.2 1.2 1.1 0.9 1.3 2.4 - 1.2

Total 99 299 423 283 97 21 2 41 1265

Rate 1.3 1.3 1.3 1.3 1.3 2.0 4.8 - 1.4

Live births 78752 221531 321065 221904 73807 10719 415 - 928512

Source:Scottish Stillbirth and Infant Death Survey

ISD Scotland (SMR02)

A six year study of the antenatal detection of fetal abnormality in six Scottish health boards

As discussed above, the six-year study of Smith and Hau2 aimed to assess the sensitivity ofprenatal diagnosis by ultrasound and biochemical methods. Among 264,481 singletonpregnancies between 1989 and 1994, there were 862 abortions undertaken because of fetalanomaly and 2123 infants delivered with potentially detectable major anomalies.

Detection rates of the following major anomalies were calculated in the study:

1. Trisomy 212. Trisomy 133. Trisomy 184. Anencephaly5. Spina bifida6. Encephalocele7. Hydrocephaly8. Hypoplastic ventricle9. Diaphragmatic hernia10.Exomphalos11.Gastroschisis12.Renal agenesis13.Sacrococcygeal teratoma14.Achondroplasia15.Thanatophoric dwarfism

The overall antenatal detection rate for these anomalies was 62%; 70% for the non-chromosomalanomalies. The authors were able to assess the impact of the introduction of biochemicalscreening at health board level on the rate of detection of Trisomy 21. The detection rate rosefrom 33% before the introduction of biochemical screening to 57.5%.

The impact of detailed midtrimester ultrasound on antenatal detection was also evaluated. Withan 18-22 week scan, the overall detection rate for nine structural anomalies (excluding thetrisomies and skeletal anomalies) was 92%.

Of our three selected anomalies, cleft lip was not considered to be consistently detectableantenatally and was therefore excluded from the six-year study. Few cardiac anomalies weredetected; with only 20 of 83 (24%) cases of hypoplastic ventricle diagnosed antenatally. Thedetection rate for spina bifida was 139/183 (76%). In pregnancies where a midtrimester scan wasundertaken, the detection rate of spina bifida was 92%, compared with only 61% in pregnancieswith no midtrimester scan. The authors concluded that their findings support a two-stagescanning policy.

RCOG working groups have agreed that a two-stage ultrasound examination programme isacceptable and have published recommendations for a two-stage scan programme comprisingan initial scan performed at the time of antenatal booking and a second at or around 20 weeksgestation. (Routine Ultrasound Screening in Pregnancy: protocol, standards and training;supplement to Ultrasound Screening for Fetal Abnormalities Report of the RCOG Working Party.July 2000)


Section 6 Antenatal detection of fetal anomalies

Section 7 Termination of pregnancy for fetal anomaly

Notifications to the Chief Medical Officer for Scotland of terminations of pregnancy provideinformation on trends over time relating to the pattern of abortions on the grounds of congenitalanomaly. Figure 7.1 shows abortions on the grounds of congenital anomaly, as a percentage ofall abortions, each year from 1988. The figure illustrates that the contribution of fetal anomaly toall abortions is consistently low at around 1%.

Figure 7.1Abortions for congenital anomaly as a percentage of all abortions(Scotland, 1988-1999)

Figure 7.2 shows the numbers of abortions undertaken for all anomalies and for neural tube andheart defects annually from 1988 to 1999.


0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

199919981997199619951994199319921991199019891988

Years

Per

cen

tag

e

Source: Notifications, to the chief medical officer for Sotland, of terminations of pregnancyunder the Abortion Act 1967

Figure 7.2Terminations with a congenital anomaly (Scotland, 1988 - 1999)

Table 7.3 shows the contribution of each of our three selected anomalies, and of Down’s syndrome,to the overall total on abortions for fetal anomaly. Over time, the contribution of neural tube defectsto the total has declined (from almost 60% in 1988 to 24% in 1999). (These data for neural tubedefects are illustrated graphically in Figure 7.4) Although remaining small, the contribution ofcardiac defects to the total has increased over time - reflecting improved antenatal detection ofthese defects.

Taken together, the data presented in this report on birth prevalence and abortions suggest a realreduction in the incidence of neural tube defects, perhaps due to folic acid supplementation orother factors.

Table 7.3Terminations with a congenital anomaly by type of anomalyNumber and percentage of all anomalies


All Nueral tube defects Heart defects Cleft Lip/palate Down’s syndromeanomalies Number % Number % Number % Number %

1988 77 46 59.7 0 0.0 0 0.0 12 15.6

1989 57 28 49.1 0 0.0 0 0.0 14 24.6

1990 73 34 46.6 0 0.0 0 0.0 16 21.9

1991 115 40 34.8 1 0.9 0 0.0 17 14.8

1992 113 35 31.0 1 0.9 0 0.0 18 15.9

1993 96 26 27.1 1 1.0 0 0.0 25 26.0

1994 103 37 35.9 2 1.9 0 0.0 23 22.3

1995 105 39 37.1 4 3.8 0 0.0 15 14.3

1996 139 52 37.4 2 1.4 0 0.0 31 22.3

1997 118 41 34.7 3 2.5 0 0.0 25 21.2

1998 136 46 33.8 5 3.7 1 0.7 27 19.9

1999 129 31 24.0 2 1.6 0 0.0 36 27.9

Source: Notifications, to the chief Medical Officer for Scotland, of terminations of

pregnancy under the Abortion Act 1967

Years

Nu

mb

ers

All anomalies

NTD

Heart defects

0

20

40

60

80

100

120

140

160

199919981997199619951994199319921991199019891988


Figure 7.4The decline in contribution of neural tube defects to all terminations for fetal anomaly(Scotland, 1988-1999).


0

10

20

30

40

50

60

70

199919981997199619951994199319921991199019891988

Years

Per

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e


1. FIGO. Report of the FIGO sub-committee on Perinatal Epidemiology & Health Statisticsfollowing a Workshop in Cairo, Nov. 11-18,1984 on the Methodology of Measurement andRecording of Infant Growth in the Perinatal Period. 1986. London, FIGO.

2. Smith NC,.Hau C. A six year study of the antenatal detection of fetal abnormality in sixScottish health boards. Brit.J.Obstet.Gynaec. 1999;106:206-12.

3. Stone DH. The Glasgow register of congenital anomalies 1972-88: a critical review.J.Inher.Metab.Dis. 1989;12:4-12.

4. SNAP Report on Cleft Lip and Palate. 1998. Edinburgh, Scottish Needs AssessmentProgramme.

5. Macfarlane A, Mugford M. Birth Counts: statistics of pregnancy and childbirth. Norwich:The Stationery Office, 2000.

6. 15 years of surveillance of congenital anomalies in Europe 1980-1994. A EUROCAT WorkingGroup. 1997. Brussels, Scientific Institute of Public Health - Louis Pasteur.

7. Croen LA,.Shaw GM. Young maternal age and congenital malformations: a population-based study. American Journal of Public Health 1995;85:710-3.

8. Waller DK, Mills JL, Simpson JL, Cunningham GC, Conley MR, Lassman MR et al. Are obesewomen at higher risk for producing malformed offspring. American Journal of Obstetrics &Gynecology 1994;170:541-8.


References

Acknowledgements

Scottish Perinatal Mortality & Morbidity Review Advisory Group (SPMMRAG)Membership (2000)

Ian Greer (Chairman, Obstetrics)Gillian Penney (Secretary, SPCERH)Ian Bashford (SEHD)Hazel Brooke (Lay representative)Elizabeth Gray (Pathology)Susan Halliday (General Practice)Una MacFadyen (Neonatology)Margaret Stewart (Midwifery)David Stone (Public Health)Beatrice Cant (ISD)Jim Chalmers (ISD)Samantha Clarke (ISD)Miranda Page (SPCERH)Lorraine Adamson (SPCERH)

SPMMRAG particularly acknowledges the assistance of the following additional members ofISD staff in the preparation of this Report: James Boyd, Ross Elder, Scott Heald, Mark Hollingsworth, Kevin McInneny, Brian Whiteman.

National Statistics

Unless otherwise specified in the ‘Data Sources’ section, the figures contained in this publicationare ‘National Statistics’.

National Statistics are produced to high professional standards, and adhere to commitmentsrelating to integrity, confidentiality, burden of collection, liaison and consultation, openness,access and timeliness. National Statistics undergo regular quality assurance reviews to ensurethat they meet customer needs, and they are produced free from political interference.

National Statistics releases are grouped under one of 13 broad subject headings (themes); thisrelease belongs to the Health and Care theme.

Further details on National Statistics are contained at the National Statistics website(http://www.statistics.gov.uk/).


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