Mental health: outcomes of 10 babies of mothers witha history of serious mental illnessK . M . M C C A U L E Y 1 R N , R M , P h D , W. C R O S S 2 R P N , P h D &J . K U L K A R N I 3 M B B S , P h D

1Senior Lecturer, School of Nursing and Midwifery, Monash University, Frankston, 2Professor/Head of School,School of Nursing and Midwifery, and 3Director/Professor, Monash Alfred Psychiatry Centre, Monash University,Melbourne, VIC, Australia

Keywords: management issues, maternal

mental health, psychotropic medications

Correspondence:

Dr K. M. McCauley

School of Nursing and Midwifery

Monash University

McMahons Road

Frankston

VIC 3199

Australia

E-mail: kay.mccauley@monash.edu

Accepted for publication: 24 August

2013

doi: 10.1111/jpm.12111

Accessible summary

• Women with serious mental illness are frequently on antipsychotic medications tomaintain their mental health (MI).

• Antipsychotic medications are currently not approved for use in pregnancybecause of the lack of evidence about their risk of harming the baby. These includekidney malformations, limb malformation and congenital heart disease.

• This case study series identifies the outcomes for 10 babies of women with seriousMI.

• Gestation of the 10 babies at birth ranged between 29 and 40 weeks, averageweight 2.9 kg. Two babies were born preterm.

• This study identifies the neonatal complications for these vulnerable babies as notoutside the norm for births in Australia.

• There was however a high rate of mother–baby separation (4/10) which is of greatconcern.

Abstract

Women with serious mental illness are frequently on antipsychotic medications tomaintain their mental health. During pregnancy there is much debate as to whether tocontinue or cease these medications. The possibility of adverse effects is of concernto clinicians and the women. This study used a case study methodology to identify theoutcomes for 10 babies of women with a history of serious mental illness. The resultsprovide further evidence in regard to women and the use of antipsychotic medicationsthroughout pregnancy and during the first year after birth. Separation of mother andbaby occurred in five of the 10 babies. This study identifies the neonatal complicationsfor these vulnerable babies as not outside the norm for births in Australia. The highrate of mother–baby separation is of great concern and needs further longitudinalstudies.

Introduction

Women with a history of psychotic-related disorders suchas schizophrenia have previously experienced a lower fer-tility rate as a consequence of the typical (traditional, firstgeneration) antipsychotic medications they were prescribed(Jarskog et al. 2000). However since the 1990s, it has beenmore common for women to be taking atypical (second

generation) antipsychotics, and therefore more womenusing such medications are becoming pregnant (McKennaet al. 2005). The generational difference between thesedrug categories relates to their influence on symptoms andtheir side effects. There remains much debate about the useof antipsychotics to maintain the woman’s mental health inpregnancy, in particular with regard to the effect these mayhave on the unborn baby. The balancing of the needs of the

Journal of Psychiatric and Mental Health Nursing, 2014, 21, 580–586

580 © 2013 John Wiley & Sons Ltd

woman with that of her growing foetus remains a concernfor all involved, health-care providers, the families and thewoman herself.

Despite the potential risks of exposure of the foetusto antipsychotic medications, and with limited evidence tothe effects these may have, women are taking these medi-cations during pregnancy (Cohen et al. 1989, McKennaet al. 2005). What is not known is the incidence of use inAustralia. Possible effects on the foetus of usingantipsychotics at this vulnerable time include potentialrisks of congenital abnormalities, neonatal toxicity andneurobehavioral consequences (Cott & Wisner 2003). Cli-nicians commonly report a lack of empirical evidence toguide the use of antipsychotics in pregnancy, data fromrandomized controlled trials is not available due to theethical considerations in using this approach and the poten-tial risks to the foetus, therefore the literature gathered hasmainly been via case studies, and drug company registerswith one prospective study (Tenyi et al. 2002, McKennaet al. 2005) and more lately through national databases(Kulkarni et al. 2008a, 2008b).

Of concern is the possibility of causing foetal abnormal-ities related specifically to the drug use. The incidence offoetal abnormality in the general population in the UnitedStates is 2–4% (Cott & Wisner 2003). In Victoria,Australia, birth defects have been reported in approxi-mately 4% of babies born. Antipsychotic medications arecurrently not approved for use in pregnancy in either theUnited States by the Food and Drug Administration (FDA)(Altshuler et al. 1996) nor in Australia by the TherapeuticGoods Administration (TGA). In 2004–2005, seven casesof neonatal defects were reported in relation to antipsy-chotic use. The foetal abnormalities included kidneymalformations, limb malformation and congenital heartdisease (Australian Adverse Drug Reactions AdvisoryCommittee (ADRAC) 2005 pers. comm.).

The TGA provides guidelines for the prescribing ofantipsychotic medicines in pregnancy with categoriza-tion of these medications (A–D) (Commonwealth ofGovernment, Australian Drug Evaluation Committee1999). Category A are those medications which have beentaken by a large number of pregnant women without anyproven increase in frequency of malformations or otherdirect or indirect harmful effects on the foetus. Category Bis where there has been no foetal risk demonstrated inanimal studies; however, no controlled studies in pregnantwomen have been reported. Category C is where animalstudies have revealed adverse outcomes for the foetus, butthere are no controlled studies in pregnant women relatedto these medications. Category D includes those drugs thathave caused, are suspected to have caused or may beexpected to cause an increased incidence of human foetal

malformations or irreversible damage (Commonwealthof Government, Australian Drug Evaluation Committee1999). Most antipsychotics are classified as category Bor C. Examples of category B antipsychotics includerisperidone, olanzapine and quetiapine, and those in cat-egory C include clozapine and haloperidol (Mims 2008).

While there is concern about the taking of theantipsychotics in pregnancy, there also exist problems withchanging dose, switching medication or ceasing the antip-sychotic. Women who discontinue taking antipsychoticmedication run a 67% risk of relapsing into psychosis(Viguera et al. 1997). The risk associated with untreatedpsychosis is that 20–50% of women may attempt suicide ofwhich 10% succeed (Allison 2004). With a relapse of psy-chotic symptoms, the woman may have difficulty in main-taining her social network and her relationships with herpartner and family who provide the critical support to herin mothering her baby (McCauley-Elsom & Kulkarni2007, McCauley-Elsom 2009). Women with a seriousmental illness such as described are reported to be morelikely to have difficulties with parenting, and as a result,may lose custody of their children (McKenna et al. 2005).The result of relapse or experiences of psychosis carries therisk of the mother harming or killing her baby (Spinelli1998, Mullick et al. 2001).

Evidence is available which identifies that clinicians inAustralia are prescribing antipsychotic medications forwomen during pregnancy despite the limited evidenceabout safe and effective practice for the woman and baby(McCauley-Elsom & Kulkarni 2007, Kulkarni et al.2008a). As there is an increasing number of women whoare becoming pregnant and remaining on antipsychotics(Littrell et al. 2000, Trixler et al. 2005), particularly thenewer atypical antipsychotics (McKenna et al. 2004,McCauley-Elsom et al. 2009a; McCauley-Elsom 2009) it isimportant to provide further information on which clini-cians can make their decisions.

Method

This project occurs within a larger case series-based studyin Australia. Ten women were followed through pregnancyand the first year after birth. The aim was to identify therelationships between antipsychotic use during pregnancyand the well-being of the mother and her baby. Maternaloutcomes have been reported elsewhere (McCauley-Elsom& Kulkarni 2007, Kulkarni et al. 2008b). This paper willpresent the data on the neonatal outcomes for the 10babies. In this study, data from multiple cases were gath-ered, analysed and presented. Yin’s (2003) frameworkenables the evidence to be gathered using a systematic anddefinable process. When using multiple cases, each case is

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examined on its own, enabling conclusions from each tocontribute to the whole study (Soy 1997). Case study(series) methodology encourages the use of multiplesources and techniques in the data-gathering process (Yin2003). Case studies investigate the real-life situation ofindividuals or groups (Soy 1997, Yin 2003). In this study,data from multiple cases have been gathered, analysed andpresented. Case study methodology encourages the use ofmultiple sources and techniques in the data-gatheringprocess. In this paper, a quantitative approach has beenutilized to describe the outcomes for the babies. Bachor(2000) identified a framework of ratios to represent occur-rences that are common within data, and this was a usefulway to analyse influences within each case and across thecases. The frequency of each of these themes is explained asa ratio (Bachor 2000) from the group as a whole (e.g. 1/10or 6/10). One example in this study would be the occur-rence of the maternal use of antipsychotic medications inpregnancy (9/10).

While the results of case studies are not usually able tobe generalized, they do need to be both reliable and valid(Yin 2003). It is important that all aspects of the informa-tion are gathered, reviewed and presented in a way whichprovides a meaningful and accurate portrayal of the out-comes in this instance for the babies. The mothers’ reportswere validated against the maternal and or baby’s medicalrecords, and with key clinicians involved in each case.Qualitative data from maternal interviews were relatedmore to the mothers view of motherhood and therefore arenot included in this paper.

Demographics and recruitment of the mothers

The women were aged 18 to 45 years, with a history ofserious mental illness, and were either pregnant or post-partum and up to 1 year after birth and were taking (9/10)or had recently taken (1/10) antipsychotic medication for apsychotic disorder. The one woman who was not on antip-sychotic at recruitment was included due to her psychiatrichistory and the high possibility of the need for a reintro-duction of this medication into her treatment regime. Themean age of the women at time of recruitment was 33.5years. For 3 of the 10 women, it was their first baby. Theywere recruited via their midwife or mental health clinician(mental health nurse or psychiatrist) from four states inAustralia.

Data collection and analysis

The women participated in telephone or face-to-face inter-views at six weekly intervals during pregnancy and afterbirth, at 6 weeks, 12 weeks, 6 months and 12 months.

Medical records of mother (and of the baby if admitted tospecial care nursery) were also accessed, with the woman’spermission, to confirm diagnosis, treatment and birth out-comes. Information gathered included general demograph-ics, psychosocial, medical and obstetric history, as well aspsychiatric and medication history. Maternal child healthrecords were not accessed directly, but information fromthese were gathered during the interviews.

The women were followed through pregnancy and up to12 months post-partum in five cases; however data for fiveof the babies was not available due to cessation in maternalcontact. In the case of the three babies taken into the careof Child Protection, no further data were available to theresearchers as such follow-up was out of scope of theethical approval. One baby died, and in regard to the fifthbaby, the mother was unable to be accessed due to a changeof address.

Yin’s case study methodology allowed for analysis usingtables, charts, figures and ratios to outline both the indi-vidual case data and case series information which thenenabled the researcher to identify common trends andpatterns (Bachor 2000, Yin 2003).

Ethical approval

Ethical approval was gained from all relevant university andclinical settings, human research and ethics committees.

Findings

The majority of the 10 women were on antipsychotic medi-cation when recruited (9/10), most were on atypicalantipsychotics with only one on an older antipsychotic.One woman had previously been treated with an antipsy-chotic (olanzapine), which had been ceased before shebecame pregnant. However, she was also smoking, takingillicit drugs and was taking a benzodiazepine (diazepam)and an antidepressant (sertraline). This woman had twoclose pregnancies (both birthed at 29 weeks) and was notrecommenced on her antipsychotic medication prior to thesecond pregnancy leading to a psychotic episode leading tothe premature birth of the second baby and two babies lessthan a year old. Only two mothers were admitted to aspecialized mother–baby unit following the birth. On dis-charge from this unit, one mother became increasinglypsychotic and stabbed her baby with a kitchen knife. Theother was discharged with her baby in the 24-h care andsupervision of her father.

Obstetric complications

Obstetric complications experienced during pregnancyincluded: intrauterine growth retardation (n = 1),

K. M. McCauley et al.

582 © 2013 John Wiley & Sons Ltd

hypertension (n = 1), gestational diabetes (n = 3), prema-ture labour and birth (n = 2), macrosomia (n = 1), one babyexperienced withdrawal syndrome from the antipsychotic.Three of the 10 babies were born by a caesarean section.The majority of babies were born healthy and well (8/10);two babies were premature. One baby was suspected ofhaving a foetal abnormality with the presence of only twocord vessels detected on ultrasound. It was also suspectedto have Trisomy 21; however, amniocentesis did notconfirm this. Gestation of the 10 babies at birth rangedbetween 29 and 40 weeks. The majority of babies wereterm at birth (average 38.5 weeks); two were premature(29 and 36 weeks gestation).

Neonatal outcomes

Baby details gathered include the sex, weight and Apgar(foetal well-being at birth) scores. There were eight femalesand two males born to the women. All babies were bornalive, but one baby died of Sudden Infant Death Syndrome(SIDS) at 6 months of age. The average Apgar scores fromthose accessed (n = 7) were good, that is out of a possiblescore of 10 taken at 1 min, and then 5 min after birth, theyreceived a score of 9 and 9 (i.e. 9:9). See Table 1 for anoverview of birth details and outcomes.

The mean weight of the 10 babies was 2961 grams (rangeof 1202–4460 grams). Table 2 identifies the antipsychoticand outcomes relating to sex and weight of the babies. Theaverage birth weight for babies whose mothers tookolanzapine in pregnancy is 3286 g, and for those whosemothers took risperidone (including Risperidone Constadepot; Janssen Pharmaceuticals, Titusville, NJ, USA)3162 g, both of which are within the normal expected range.

Special care admissions

Two babies were born prematurely, one at 29 weeks (Baby 1)and the second (Baby 2) at 36 weeks gestation. Both wereadmitted to special care nurseries. Baby 1 required admis-sion to the neonatal intensive care unit and was ventilatedfor several days with a diagnosis of Hyaline MembraneDisease (HMD). The length of admission was 13 weeks forBaby 1 and 6 weeks for Baby 2. Baby 1 died from SIDS aged6 months. This baby was also the baby which was suspectedas having Trisomy 21 antenatally and was born with oneumbilical artery. No diagnosis was confirmed, and the babywas reported to be normal on coroner’s report. Furtherproblems encountered by both babies included feedingproblems and jaundice.

Follow-up of babies

The findings of this study show the significant impact ofmaternal mental illness on the outcomes for the mother–

baby dyad with three mothers losing custody of theirbabies where these babies were placed in the care of otherfamily members. One baby sustained an injury while itsmother was under the influence of psychotic symptoms.This baby was placed in care after being stabbed with akitchen knife. The baby sustained a small non-fatal injuryand was admitted to the paediatric unit for observation.Despite one mother being offered treatment in the mother–baby unit, she declined, and subsequently the baby wasremoved within 2 days of birth.

The growth and development of the babies was reportedfrom feedback received by the mothers from their generalpractitioner or paediatrician, the Maternal and ChildHealth nurse (MCHN) and from information recorded intheir child health book. Of those babies followed up to 1year of age (n = 5), four were reported by their mothers tobe walking and talking by 12 months, however, one babywas standing but still not walking at that time. Details forthe three babies placed in care were unavailable.

Discussion

It is evident that antipsychotic medications are being usedfor the treatment of women with psychosis in pregnancy inAustralia. The results of this small case series outline theneonatal outcomes for 10 babies born to mothers whowere taking antipsychotic medication during pregnancy,and the findings reflect that for 50% of the women andtheir babies, the outcomes are negative: three babiesremoved from the mother and two others required specialor neonatal intensive care. For the 50% of women who hadpositive outcomes, all were closely case managed and hadstrong social supports including their partner and parents.In addition they were clean of illicit substances.

These results are consistent with the literature wheresuch separation of mother and baby due to admission forspecial care and/or because the Child Protection Agencyassess the baby as being ‘at risk’ are evident and a realityand well described (McCauley-Elsom & Kulkarni 2007,Kulkarni et al. 2008b). With 50% of mothers and babies inthis study experiencing separation, the social and develop-mental implications clearly need careful monitoring, andpreventative strategies need to be in place during pregnancyto improve these outcomes. Kulkarni et al. (2008b) notethat women with psychosis need specific social interven-tions to promote positive outcomes for both baby andmother. There are multiple mother–baby units acrossAustralia, yet only three of the women in this study wereoffered access to this specialized and targeted service thatimproves outcomes for both mother and baby, and onlytwo actually utilizing the service. Clinicians supportingwomen with psychosis during their pregnancies need to be

Outcomes for babies

© 2013 John Wiley & Sons Ltd 583

Tab

le1

Neo

nat

alo

utc

om

es

Sex

of

bab

yW

eeks

atb

irth

Wei

gh

tA

pg

arsc

ore

SCN

Pro

ble

ms

Ab

no

rmal

ity

Bre

astf

eed

ing

1Fe

mal

e36

2016

9:9

Yes

•Pr

emat

uri

ty•

IUG

R•

HM

D•

Jau

nd

ice

•Fe

edin

gp

rob

lem

s

Nil

No

2Fe

mal

e40

3634

9:9

no

Nil

•U

mb

ilica

lh

ern

iaY

es 12m

on

ths

3Fe

mal

e40

3100

n/a

no

Nil

Nil

Yes 2

wee

ks4

Mal

e39

2830

n/a

no

Nil

Nil

No

5M

ale

4025

70n

/an

oN

ilN

ilN

o6

Fem

ale

3839

006:

9n

oN

ilN

ilN

o7

Mal

e29

1202

8:9

Yes

•Pr

emat

uri

ty•

HM

D•

Jau

nd

ice

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edin

gp

rob

lem

s•

Gas

tro

-O

eso

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l-R

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Ab

do

min

ald

iste

nsi

on

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all

bo

wel

ob

stru

ctio

n•

SID

s

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my

21?

•Si

ng

leu

mb

ilica

lar

tery

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mb

ilica

lh

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ia•

Hir

sch

spru

ng

’sD

isea

se?

Mix

ed–

bre

ast

milk

and

form

ula

feed

ing

8Fe

mal

e38

3000

n/a

no

Nil

Nil

Un

kno

wn

9Fe

mal

e40

2900

9:9

no

Nil

Nil

Yes 12

mo

nth

s10

Fem

ale

3944

608:

9n

oN

ilN

ilY

es 12m

on

ths

HM

D,

Hya

line

Mem

bra

ne

Dis

ease

;IU

GR

,In

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Ret

ard

atio

n;

SCN

,Sp

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DS,

Sud

den

Infa

nt

Dea

thSy

nd

rom

e.

K. M. McCauley et al.

584 © 2013 John Wiley & Sons Ltd

aware of these services and make the necessary arrange-ments in consultation with the woman and her supports toensure timely access and admission. Clinicians withinmother–baby units need to be involved in the assessment ofpregnant women who also have a mental illness.

There remains ongoing debate among clinicians andresearchers concerning the ethical issues and safety of theuse of antipsychotic medications in pregnancy andbreastfeeding (Altshuler et al. 1996, Trixler & Tenyi 1997,Cohen & Rosenbaum 1998, Littrell et al. 2000, Pinkofsky2000, Jain & Lacy 2005, McKenna et al. 2005, Usher et al.2005; McCauley-Elsom et al. 2009b). However, medica-tion adherence and maintenance of support networks(clinical and social) have been shown to greatly enhance theoutcomes for mothers and their babies (McCauley-Elsom& Kulkarni 2007, Kulkarni et al. 2008b; McCauley-Elsomet al. 2009a). Clearly the influence of antipsychotics in themanagement of women with serious mental illness at thiscritical time requires careful consideration, planning, mul-tidisciplinary planning and consistency in care. Medica-tions are not the only answer. Social support and close casemanagement will assist in promoting positive outcomes formother and baby.

Limitations

A number of issues contributed to the small sample fol-lowed through to the 1-year completion in this study. Theseincluded: the inability to access information about babiesplaced in care and the choice of two of the women not tocontinue in the study (one woman whose baby died and theother one who stabbed her baby). Contact with five of thewomen was lost during the period of 3–6 months after theirbabies’ birth, in most cases due to child protection issuesand the problems experienced by the women in relation toongoing custody battles and or because they moved toanother address and were unable to be followed up.

While the sample size (n = 10) meant that the findings arenot generalizable, they do however make a valuable contri-bution to the knowledge of the management and outcomesfor women with serious mental illness and their babies inAustralia. The use of self-reporting as a method of datacollection has been regarded as a potential limitation. Self-reporting is noted to be a good method of gathering infor-mation directly from informants in response to researchquestions (Roberts & Taylor 2002). It is acknowledged,however, that verbal reporting has some weaknesses, par-ticularly in relation to the validity and accuracy of thereports. To offset this weakness, several methods wereimplemented to ensure validation of data. The initial datawere gathered from the women and then confirmed by theresearcher contacting key health-care clinicians, and thenalso reviewing the medical notes for both mother and baby.

Conclusion

The babies in this study had clinical outcomes not dissimi-lar to those born to women who have no history of mentalillness. The adverse outcomes, which do require ongoingmonitoring, included gestational diabetes and the conse-quences for the baby such as macrosomia, IntrauterineGrowth Retardation and/or prematurity requiring admis-sion of the baby to special care nurseries. The key concernfor the women was the possibility of abnormalities relatedto the use of medications in pregnancy. However for thissmall number of women, no major abnormalities wereidentified. What must be given consideration is theoutcome for the mother–baby dyad, the safety of the babymust be foremost in clinicians’ minds, with the idealoutcome of a healthy mother and a healthy baby with ahealthy mother–baby relationship. Further research isrequired to identify the care planning and support that isrequired to achieve this, in particular, multidisciplinarycase management, medication adherence, maintenance ofstrong support networks and planned admissions tomother–baby units.

Currently, there is no evidence available to identify long-term outcomes for babies whose mothers have taken theatypical antipsychotics now available and taken by manywomen with serious mental illness. Pregnancy must be aconsideration for all clinicians in relation to the care of thisvulnerable group of women. The long-term outcomes forthis vulnerable group of babies are currently being under-taken in a longitudinal study in progress at the MonashAlfred Psychiatry Research Centre in Australia as part ofthe National Register of Antipsychotic Medications inPregnancy (NRAMP).

Table 2Sex and weight by antipsychotic

Antipsychotic Sex Weight in grams

1 Risperidone Female 20162 Risperidone Female 36343 Risperidone Female 31004 Olanzapine Male 28305 Olanzapine Male 25706 Risperidone (consta) Female 39007 Nil Male 12028 Quetiapine Female 30009 Haloperidol Female 2900

10 Olanzapine Female 4460

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