Antenatal and postnatal mental health potx

“One in seven women will have some kind of psychologicalproblem during the antenatal and postnatal periods and it is absolutely vital that healthcare professionals, including midwives an

“One in seven women will have some kind of psychological

problem during the antenatal and postnatal periods and it is

absolutely vital that healthcare professionals, including

midwives and health visitors, are able to identify those women

who are at risk of developing a mental health problem during

pregnancy and after giving birth This guideline is an indispensable tool to aid professionals in that endeavour."

Dr Gwyneth Lewis, National Clinical Lead for Maternal Health and Maternity Services and Director of the Maternal Deaths Enquiry for CEMACH

The guideline, commissioned by NICE and developed by the National Collaborating

Centre for Mental Health (NCCMH), covers the care and treatment of women with

mental health problems during pregnancy and the first postnatal year This includes

depression, anxiety disorders, and severe mental illnesses such as bipolar disorder

and schizophrenia

The impact of mental disorders on women, their infants and other members of their

family can be greater during pregnancy and the postnatal period than at any other

time It is therefore of great importance that any problem is recognised and managed

quickly and safely The guideline sets out clear recommendations, based on the best

available evidence, for healthcare staff on how to work with pregnant and

breastfeeding women to significantly improve their treatment and care

This publication brings together all of the evidence that led to the recommendations

in the guideline It provides an overview of how mental health problems manifest

during pregnancy and postnatally and covers prediction and detection, prevention,

and psychological and pharmacological interventions for specific disorders, including

balancing the risks and benefits of drug treatment during pregnancy and while

breastfeeding The guideline also encompasses the organisation of perinatal mental

health services, making it the first of its kind to fully integrate the clinical and service

aspects of care into a single volume The book is illustrated by women’s experiences

of mental health problems, treatment and services

An accompanying CD contains further information about the evidence, including:

● included and excluded studies

● profile tables that summarise both the quality of the evidence and the results

of the evidence synthesis

● all meta-analytical data presented as forest plots

● detailed information about how to use and interpret forest plots

AND SERVICE GUIDANCE

& The Royal College of Psychiatrists, 2007

The views presented in this book do not necessarily reflect those of the British Psychological Society, and the publishers are not responsible for any error of omission or fact The British Psychological Society is a registered charity (no 229642).

All rights reserved No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers Enquiries in this regard should be directed to the British Psychological Society.

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from

the British Library.

ISBN-: 978-1-85433-454-1

Printed in Great Britain by Alden Press.

developed by National Collaborating Centre for Mental Health

Royal College of Psychiatrists’ Research and Training Unit

4th Floor, Standon House

21 Mansell Street London E1 8AA

commissioned by National Institute for Health and Clinical Excellence

MidCity Place, 71 High Holborn

London WCIV 6NA www.nice.org.uk

published by The British Psychological Society

St Andrews House

48 Princess Road East

Leicester LE1 7DR www.bps.org.uk

and

The Royal College of Psychiatrists

17 Belgrave Square

London SW1X 8PG www.rcpsych.ac.uk

1.1 Principles of care for all women with mental disorders during

1.2 Prediction, detection and initial management of mental disorders 12

1.4 Care of women with a mental disorder during pregnancy and

3.8 Testimonies from women with mental disorders in the

4 ANTENATAL AND POSTNATAL MENTAL

4.5 Consequences of mental disorder during pregnancy and the

4.7 The economic burden of mental disorders in the antenatal

4.8 Explaining risk to women: helping patients to make decisions

5 THE PREDICTION AND DETECTION OF MENTAL

ILLNESS DURING PREGNANCY AND THE

5.2 Prediction – risk factors for the onset of mental disorder

5.3 Methods for predicting mental disorder during pregnancy

5.4 Methods for detecting mental disorder during pregnancy

6.5 Review of treatments aimed at preventing the development

of mental disorders during the antenatal and postnatal

6.6 Health economics evidence on psychological and

psychosocial interventions aimed at preventing the development

of depression during the antenatal and postnatal periods

in women with identified psychosocial risk factors and/or

6.8 Review of treatments aimed at preventing the development

of mental disorders during the antenatal and postnatal periods

6.9 Review of non-pharmacological treatments for depression

6.10 Health economics evidence on psychosocial interventions

6.11 Focusing on the infant: intervening in the mother-infant

7 THE PHARMACOLOGICAL TREATMENT OF MENTAL

DISORDERS IN PREGNANT AND BREASTFEEDING

7.2 Risk associated with specific drugs in pregnancy

7.3 The pharmacological treatment of mental disorder

during pregnancy and the postnatal period – review

7.4 Prescribing psychotropic medication to pregnant

7.5 The pharmacological treatment of specific mental disorders

during pregnancy and the postnatal period – adaptation

8 THE ORGANISATION OF PERINATAL MENTAL

8.4 The functions of services for women, their partners and

8.6 Implementing the managed network model:

GUIDELINE DEVELOPMENT GROUP MEMBERSHIP

Dr Dave Tomson

Guideline Development Group Chair

GP and Consultant in patient-centred primary care, North Shields

Mr Stephen Pilling

Facilitator, Guideline Development Group

Joint Director, National Collaborating Centre for Mental Health

Director, Centre for Outcomes, Research and Effectiveness, University

College London

Consultant Clinical Psychologist, Camden and Islington Mental Health

and Social Care Trust

Service user representative, Guideline Development Group

Senior Lecturer in Health and Social Care, University of Gloucestershire

Project Manager (August 2006–present), National Collaborating Centre

for Mental Health

The antenatal and postnatal mental health Guideline Development Group and reviewteam at the National Collaborating Centre for Mental Health would like to thank thefollowing people:

Those women who have experienced mental health problems in the antenatal or postnatal period who contributed testimonies that have been included in this guideline

Those who acted as advisers on specialist topics or have contributed to the process by reviewing drafts of the guideline:

Speakers in a consensus conference on the pharmacological management

of mental disorders in pregnancy and lactating women:

Professor David Chadwick

Professor Nicol Ferrier

1 EXECUTIVE SUMMARY

KEY PRIORITIES FOR IMPLEMENTATION

The following recommendations have been identified as recommendations for implementation

Prediction and detection

● At a woman’s first contact with services in both the antenatal and postnatal ods, healthcare professionals (including midwives, obstetricians, health visitorsand GPs) should ask questions about:

peri-– past or present severe mental illness including schizophrenia, bipolar disorder,psychosis in the postnatal period and severe depression

– previous treatment by a psychiatrist/specialist mental health team includinginpatient care

– a family history of perinatal mental illness

Other specific predictors, such as poor relationships with her partner, should not beused for the routine prediction of the development of a mental disorder

● At a woman’s first contact with primary care, at her booking visit and postnatally(usually at 4 to 6 weeks and 3 to 4 months), healthcare professionals (includingmidwives, obstetricians, health visitors and GPs) should ask two questions toidentify possible depression

– During the past month, have you often been bothered by feeling down,depressed or hopeless?

– During the past month, have you often been bothered by having little interest orpleasure in doing things?

A third question should be considered if the woman answers ‘yes’ to either of theinitial questions

– Is this something you feel you need or want help with?

Psychological treatments

● Women requiring psychological treatment should be seen for treatment normallywithin 1 month of initial assessment, and no longer than 3 months afterwards.This is because of the lower threshold for access to psychological therapies duringpregnancy and the postnatal period arising from the changing risk–benefit ratiofor psychotropic medication at this time

Explaining risks

● Before treatment decisions are made, healthcare professionals should discusswith the woman the absolute and relative risks associated with treating and nottreating the mental disorder during pregnancy and the postnatal period Theyshould:

– acknowledge the uncertainty surrounding the risks

– explain the background risk of fetal malformations for pregnant women without

a mental disorder

– describe risks using natural frequencies rather than percentages (for example,

1 in 10 rather than 10%) and common denominators (for example, 1 in 100 and

25 in 100, rather than 1 in 100 and 1 in 4)

– if possible use decision aids in a variety of verbal and visual formats that focus

on an individualised view of the risks

– provide written material to explain the risks (preferably individualised) and, ifpossible, audio-taped records of the consultation

Management of depression

prescribers should, while bearing in mind that the safety of these drugs is not wellunderstood, take into account that:

– tricyclic antidepressants, such as amitriptyline, imipramine and nortriptyline,have lower known risks during pregnancy than other antidepressants

– most tricyclic antidepressants have a higher fatal toxicity index than selectiveserotonin reuptake inhibitors (SSRIs)

– fluoxetine is the SSRI with the lowest known risk during pregnancy

– imipramine, nortriptyline and sertraline are present in breast milk at relativelylow levels

– citalopram and fluoxetine are present in breast milk at relatively high levels– SSRIs taken after 20 weeks’ gestation may be associated with an increased risk

of persistent pulmonary hypertension in the neonate

– paroxetine taken in the first trimester may be associated with fetal heart defects– venlafaxine may be associated with increased risk of high blood pressure

at high doses, higher toxicity in overdose than SSRIs and some tricyclic depressants, and increased difficulty in withdrawal

anti-– all antidepressants carry the risk of withdrawal or toxicity in neonates; in mostcases the effects are mild and self-limiting

● For a woman who develops mild or moderate depression during pregnancy or thepostnatal period, the following should be considered:

– self-help strategies (guided self-help, computerised cognitive behavioural therapy

or exercise)

– non-directive counselling delivered at home (listening visits)

– brief cognitive behavioural therapy and interpersonal psychotherapy

Organisation of care

● Clinical networks should be established for perinatal mental health services,managed by a coordinating board of healthcare professionals, commissioners,managers, and service users and carers These networks should provide:

– a specialist multidisciplinary perinatal service in each locality, which providesdirect services, consultation and advice to maternity services, other mentalhealth services and community services; in areas of high morbidity these serv-ices may be provided by separate specialist perinatal teams

– access to specialist expert advice on the risks and benefits of psychotropicmedication during pregnancy and breastfeeding

– clear referral and management protocols for services across all levels of theexisting stepped-care frameworks for mental disorders, to ensure effectivetransfer of information and continuity of care

– pathways of care for service users, with defined roles and competencies for allprofessional groups involved

DISORDERS DURING PREGNANCY AND

THE POSTNATAL PERIOD

1.1.1.1 Women with an existing mental disorder who are pregnant or planning a

pregnancy, and women who develop a mental disorder during pregnancy orthe postnatal period, should be given culturally sensitive information ateach stage of assessment, diagnosis, course and treatment about the impact

of the disorder and its treatment on their health and the health of their fetus

or child This information should cover the proper use and likely sideeffects of medication

1.1.1.2 Healthcare professionals should work to develop a trusting relationship

with the woman, and where appropriate and acceptable to the woman, herpartner and family members and carers In particular, they should:

● explore the woman’s ideas, concerns and expectations and regularlycheck her understanding of the issues

● discuss the level of involvement of the woman’s partner, familymembers and carers, and their role in supporting the woman

● be sensitive to the issues of stigma and shame in relation to mental illness.1.1.1.3 Healthcare professionals should ensure that adequate systems are in place

to ensure continuity of care and effective transfer of information, to reducethe need for multiple assessments

1.1.1.4 Healthcare professionals should discuss contraception and the risks of

preg-nancy (including relapse, risk to the fetus and risks associated with stopping orchanging medication) with all women of child-bearing potential who have an

existing mental disorder and/or who are taking psychotropic medication Suchwomen should be encouraged to discuss pregnancy plans with their doctor.

1.1.2.1 Healthcare professionals should assess and, where appropriate address, the

needs of the partner, family members and carers of a woman with a mentaldisorder during pregnancy and the postnatal period, including:

● the welfare of her infant, and other dependent children and adults

● the impact of any mental disorder on relationships with her partner,family members and carers

1.1.3.1 Healthcare professionals working with adolescents experiencing a mental

disorder during pregnancy or the postnatal period should:

● be familiar with local and national guidelines on confidentiality and therights of the child

● obtain appropriate consent, bearing in mind the adolescent’s standing (including Gillick competence1), parental consent and respon-sibilities, child protection issues, and the use of the Mental Health Actand of the Children Act (1989)

OF MENTAL DISORDERS

1.2.1.1 In all communications (including initial referral) with maternity services,

healthcare professionals should include information on any relevanthistory of mental disorder

1.2.1.2 At a woman’s first contact with services in both the antenatal and

postna-tal periods, healthcare professionals (including midwives, obstetricians,health visitors and GPs) should ask about:

● past or present severe mental illness including schizophrenia, bipolardisorder, psychosis in the postnatal period and severe depression

● previous treatment by a psychiatrist/specialist mental health teamincluding inpatient care

● a family history of perinatal mental illness

Other specific predictors, such as poor relationships with her partner,should not be used for the routine prediction of the development of amental disorder.

1.2.1.3 At a woman’s first contact with primary care, at her booking visit and

post-natally (usually at 4 to 6 weeks and 3 to 4 months), healthcare als (including midwives, obstetricians, health visitors and GPs) should asktwo questions to identify possible depression

profession-● During the past month, have you often been bothered by feeling down,depressed or hopeless?

● During the past month, have you often been bothered by having littleinterest or pleasure in doing things?

A third question should be considered if the woman answers ‘yes’ to either

of the initial questions

● Is this something you feel you need or want help with?

1.2.1.4 Healthcare professionals may consider the use of self-report measures

such as the Edinburgh Postnatal Depression Scale (EPDS), HospitalAnxiety and Depression Scale (HADS) or Patient Health Questionnaire-9(PHQ-9) as part of a subsequent assessment or for the routine monitoring ofoutcomes

1.2.2.1 After identifying a possible mental disorder in a woman during pregnancy

or the postnatal period, further assessment should be considered, in tation with colleagues if necessary

consul-● If the healthcare professional or the woman has significant concerns,the woman should normally be referred for further assessment toher GP

● If the woman has, or is suspected to have, a severe mental illness (forexample, bipolar disorder or schizophrenia), she should be referred to aspecialist mental health service, including, if appropriate, a specialistperinatal mental health service This should be discussed with thewoman and preferably with her GP

● The woman’s GP should be informed in all cases in which a possiblecurrent mental disorder or a history of significant mental disorder isdetected, even if no further assessment or referral is made

1.2.2.2 If a woman has a current mental disorder or a history of severe mental

illness, she should be asked about her mental health at all subsequentcontacts

1.2.2.3 A written care plan covering pregnancy, delivery and the postnatal period

should be developed for pregnant women with a current or past history ofsevere mental illness, usually in the first trimester It should:

● be developed in collaboration with the woman and her partner, familyand carers, and relevant healthcare professionals

● include increased contact with specialist mental health services ing, if appropriate, specialist perinatal mental health services)

(includ-● be recorded in all versions of the woman’s notes (her own records andmaternity, primary care and mental health notes) and communicated tothe woman and all relevant healthcare professionals

1.2.2.4 Women who need inpatient care for a mental disorder within 12 months of

childbirth should normally be admitted to a specialist mother and babyunit, unless there are specific reasons for not doing so

1.2.2.5 Managers and senior healthcare professionals responsible for perinatal

mental health services (including those working in maternity and primarycare services) should ensure that:

● there are clearly specified care pathways so that all primary and ary healthcare professionals involved in the care of women during preg-nancy and the postnatal period know how to access assessment andtreatment

second-● staff have supervision and training, covering mental disorders, ment methods and referral routes, to allow them to follow the care pathways

1.3.1.1 For pregnant women who have symptoms of depression and/or anxiety that

do not meet diagnostic criteria but significantly interfere with personal andsocial functioning, healthcare professionals should consider:

● for women who have had a previous episode of depression or anxiety,offering individual brief psychological treatment (four to six sessions),such as interpersonal psychotherapy (IPT) or cognitive behaviouraltherapy (CBT)

● for women who have not had a previous episode of depression or ety, offering social support during pregnancy and the postnatal period;such support may consist of regular informal individual or group-basedsupport

anxi-1.3.1.2 Psychosocial interventions (for example, group psychoeducation) designed

specifically to reduce the likelihood of developing a mental disorder duringpregnancy or the postnatal period should not be part of routine antenataland postnatal care

1.3.1.3 Single-session formal debriefing focused on the birth should not be

routinely offered to women who have experienced a traumatic birth.However, maternity staff and other healthcare professionals should supportwomen who wish to talk about their experience, encourage them to makeuse of natural support systems available from family and friends, and takeinto account the effect of the birth on the partner

1.3.1.4 Mothers whose infants are stillborn or die soon after birth should not be

routinely encouraged to see and hold the dead infant These women

should be offered an appropriate follow-up appointment in primary orsecondary care.

PREGNANCY AND THE POSTNATAL PERIOD

risks and benefits

1.4.1.1 Women requiring psychological treatment should be seen for treatment

normally within 1 month of initial assessment, and no longer than 3months afterwards This is because of the lower threshold for access topsychological therapies during pregnancy and the postnatal period arisingfrom the changing risk–benefit ratio for psychotropic medication at thistime

disorder who is planning a pregnancy, pregnant or breastfeeding shouldcover:

● the risk of relapse or deterioration in symptoms and the woman’s ity to cope with untreated or subthreshold symptoms

abil-● severity of previous episodes, response to treatment and the woman’spreference

● the possibility that stopping a drug with known teratogenic risk afterpregnancy is confirmed may not remove the risk of malformations

● the risks from stopping medication abruptly

● the need for prompt treatment because of the potential impact of anuntreated mental disorder on the fetus or infant

● the increased risk of harm associated with drug treatments during nancy and the postnatal period, including the risk in overdose

preg-● treatment options that would enable the woman to breastfeed if shewishes, rather than recommending she does not breastfeed

1.4.1.3 When prescribing a drug for a woman with a mental disorder who is

planning a pregnancy, pregnant or breastfeeding, prescribers should:

● choose drugs with lower risk profiles for the mother and the fetus orinfant

● start at the lowest effective dose, and slowly increase it; this is larly important where the risks may be dose related

particu-● use monotherapy in preference to combination treatment

● consider additional precautions for preterm, low birthweight or sickinfants

1.4.1.4 When stopping a drug in a woman with a mental disorder who is planning

a pregnancy, pregnant or breastfeeding, take into account:

● NICE guidance on the specific disorder (see NICE, 2002, 2004a,2004b, 2004c, 2005a, 2005c, 2006)

● the risk to the fetus or infant during the withdrawal period

● the risk from not treating the disorder

1.4.2.1 Before treatment decisions are made, healthcare professionals should

discuss with the woman the absolute and relative risks associated withtreating and not treating the mental disorder during pregnancy and thepostnatal period They should:

● acknowledge the uncertainty surrounding the risks

● explain the background risk of fetal malformations for pregnant womenwithout a mental disorder

● describe risks using natural frequencies rather than percentages (forexample, 1 in 10 rather than 10%) and common denominators (forexample, 1 in 100 and 25 in 100, rather than 1 in 100 and 1 in 4)

● if possible use decision aids in a variety of verbal and visual formatsthat focus on an individualised view of the risks

● provide written material to explain the risks (preferably individualised)and, if possible, audio-taped records of the consultation

during pregnancy and the postnatal period

Antidepressants

1.4.3.1 If a woman taking paroxetine is planning a pregnancy or has an unplanned

pregnancy, she should be advised to stop taking the drug

1.4.3.2 When choosing an antidepressant for pregnant or breastfeeding women,

prescribers should, while bearing in mind that the safety of these drugs isnot well understood, take into account that:

● tricyclic antidepressants, such as amitriptyline, imipramine andnortriptyline, have lower known risks during pregnancy than other anti-depressants

● most tricyclic antidepressants, have a higher fatal toxicity index thanselective serotonin reuptake inhibitors (SSRIs)

● fluoxetine is the SSRI with the lowest known risk during pregnancy

● imipramine, nortriptyline and sertraline are present in breast milk atrelatively low levels

● citalopram and fluoxetine are present in breast milk at relatively high levels

● SSRIs taken after 20 weeks’ gestation may be associated with anincreased risk of persistent pulmonary hypertension in the neonate

● paroxetine taken in the first trimester may be associated with fetal heartdefects

● venlafaxine may be associated with increased risk of high blood sure at high doses, higher toxicity in overdose than SSRIs and sometricyclic antidepressants, and increased difficulty in withdrawal

pres-● all antidepressants carry the risk of withdrawal or toxicity in neonates;

in most cases the effects are mild and self-limiting

Benzodiazepines

1.4.3.3 Benzodiazepines should not be routinely prescribed for pregnant women,

except for the short-term treatment of extreme anxiety and agitation This

is because of the risks to the fetus (for example, cleft palate) and theneonate (for example, floppy baby syndrome) Consider gradually stop-ping benzodiazepines in women who are pregnant

Antipsychotics

1.4.3.4 Women taking antipsychotics who are planning a pregnancy should be told

that the raised prolactin levels associated with some antipsychotics (notablyamisulpride, risperidone and sulpiride) reduce the chances of conception Ifprolactin levels are raised, an alternative drug should be considered.1.4.3.5 If a pregnant woman is taking clozapine, switching to another drug and

careful monitoring should be considered Clozapine should not beroutinely prescribed for women who are pregnant (because there is a theo-retical risk of agranulocytosis in the fetus) or for women who are breast-feeding (because it reaches high levels in breast milk and there is a risk ofagranulocytosis in the infant)

1.4.3.6 When deciding whether to prescribe olanzapine to a woman who is

preg-nant, risk factors for gestational diabetes and weight gain, including familyhistory, existing weight and ethnicity, should be taken into account.1.4.3.7 Depot antipsychotics should not be routinely prescribed to pregnant

women because there is relatively little information on their safety, andtheir infants may show extrapyramidal symptoms several months afteradministration of the depot These are usually self-limiting

1.4.3.8 Anticholinergic drugs should not be prescribed for the extrapyramidal side

effects of antipsychotic drugs except for acute short-term use Instead, thedose and timing of the antipsychotic drug should be adjusted, or the drugchanged

Valproate

1.4.3.9 Valproate should not be routinely prescribed to women of child-bearing

potential If there is no effective alternative, the risks of taking valproate

during pregnancy, and the importance of using adequate contraception,should be explained.

1.4.3.10 Valproate should not be prescribed to women younger than 18 years

because of the risk of polycystic ovary syndrome and increased risk ofunplanned pregnancy in this age group

1.4.3.11 If a woman who is taking valproate is planning a pregnancy, or is pregnant,

she should be advised to stop taking the drug Where appropriate in thetreatment of bipolar disorder, an alternative drug (usually an antipsychotic)should be considered

1.4.3.12 If there is no alternative to valproate, doses should be limited to a

maxi-mum of 1 gram per day, administered in divided doses and in the slowrelease form, with 5 mg/day folic acid However, it is not clear how theserum level of valproate affects the risk of abnormalities

Lithium

1.4.3.13 Lithium should not be routinely prescribed for women, particularly in the

first trimester of pregnancy (because of the risk of cardiac malformations inthe fetus) or during breastfeeding (because of the high levels in breast milk).1.4.3.14 If a woman taking lithium is planning a pregnancy, and is well and not at

high risk of relapse, she should be advised to stop taking the drug because

of the risk of cardiac malformations in the fetus

1.4.3.15 If a woman who is taking lithium becomes pregnant:

● if the pregnancy is confirmed in the first trimester, and the woman iswell and not at high risk of relapse, lithium should be stopped gradu-ally over 4 weeks; it should be explained that this may not remove therisk of cardiac defects in the fetus

● if the woman is not well or is at high risk of relapse, the followingshould be considered:

– switching gradually to an antipsychotic, or

– stopping lithium and restarting it in the second trimester if thewoman is not planning to breastfeed and her symptoms haveresponded better to lithium than to other drugs in the past, or– continuing with lithium if she is at high risk of relapse

1.4.3.16 If a woman continues taking lithium during pregnancy, serum lithium

levels should be checked every 4 weeks, then weekly from the 36th week,and less than 24 hours after childbirth; the dose should be adjusted to keepserum levels towards the lower end of the therapeutic range, and thewoman should maintain adequate fluid intake

1.4.3.17 Women taking lithium should deliver in hospital, and be monitored during

labour by the obstetric team Monitoring should include fluid balance,because of the risk of dehydration and lithium toxicity (in prolongedlabour, it may be appropriate to check serum lithium levels)

Carbamazepine and lamotrigine

1.4.3.18 If a woman who is taking carbamazepine or lamotrigine is planning a

preg-nancy or has an unplanned pregpreg-nancy, healthcare professionals shouldadvise her to stop taking these drugs because of the risk of neural tubedefects and other malformations in the fetus If appropriate an alternativedrug (such as an antipsychotic) should be considered

1.4.3.19 Carbamazepine or lamotrigine should not be routinely prescribed for

women who are pregnant because of the lack of evidence of efficacy andthe risk of neural tube defects in the fetus

1.4.3.20 Lamotrigine should not be routinely prescribed for women who are

breast-feeding because of the risk of dermatological problems in the infant, such

as Stevens–Johnson syndrome

during early pregnancy or while breastfeeding

(lithium, valproate, carbamazepine, lamotrigine and paroxetine) at the time

of conception and/or in the first trimester, healthcare professionals should:

● confirm the pregnancy as quickly as possible

● offer appropriate screening and counselling about the continuation ofthe pregnancy, the need for additional monitoring and the risks to thefetus if the woman continues to take medication

● undertake a full paediatric assessment of the newborn infant

● monitor the infant in the first few weeks after delivery for adverse drug effects, drug toxicity or withdrawal (for example, floppy baby syndrome, irritability, constant crying, shivering, tremor, restless-ness, increased tone, feeding and sleeping difficulties and, rarely,seizures); if the mother was prescribed antidepressants in the lasttrimester, these may result from serotonergic toxicity syndrome ratherthan withdrawal

1.4.4.2 Infants of mothers who are breastfeeding while taking psychotropic

medication should be monitored for adverse reactions

1.4.5.1 Pregnant women with a mental disorder who have sleep problems should

initially be given general advice about sleep hygiene (including bedtimeroutines, the avoidance of caffeine, and the reduction of activity beforesleep) For women with serious and chronic problems, low-dose chlorpro-mazine or low-dose amitriptyline may be considered

1.4.6 Electroconvulsive therapy (ECT)

1.4.6.1 A course of ECT should be considered for pregnant women with severe

depression, severe mixed affective states or mania in the context of bipolardisorder, or catatonia, whose physical health or that of the fetus is atserious risk

1.4.7.1 A pregnant woman requiring rapid tranquillisation should be treated

according to the NICE clinical guidelines on the short-term management

of disturbed/violent behaviour, schizophrenia and bipolar disorder (seeNICE [2005d, 2002, 2006] for details), except that:

● she should not be secluded after rapid tranquillisation

● restraint procedures should be adapted to avoid possible harm to the fetus

● when choosing an agent for rapid tranquillisation in a pregnant woman,

an antipsychotic or a benzodiazepine with a short half-life should beconsidered; if an antipsychotic is used, it should be at the minimumeffective dose because of neonatal extrapyramidal symptoms; if abenzodiazepine is used, the risks of floppy baby syndrome should betaken into account

● during the perinatal period, the woman’s care should be managed inclose collaboration with a paediatrician and an anaesthetist

This section recommends how NICE guidance on specific mental disorders may beadapted for women who are planning a pregnancy, pregnant or breastfeeding Itshould be read in conjunction with the rest of the advice in section 1.4

1.4.8.1 If a woman being treated for mild depression is taking an antidepressant,

the medication should be withdrawn gradually and monitoring (‘watchfulwaiting’) considered If intervention is then needed the following should beconsidered:

● self-help approaches (guided self-help, computerised CBT [C-CBT],exercise) or

● brief psychological treatments (including counselling, CBT and IPT)

1.4.8.2 If a woman is taking an antidepressant and her latest presentation was a

moderate depressive episode, the following options should be discussedwith the woman, taking into account previous response to treatment, herpreference, and risk:

● switching to psychological therapy (CBT or IPT)

● switching to an antidepressant with lower risk

1.4.8.3 If a woman is taking an antidepressant and her latest presentation was a

severe depressive episode, the following options should be discussed withthe woman, taking into account previous response to treatment, her prefer-ence, and risk:

● combining drug treatment with psychological treatment, but switching

to an antidepressant with lower risk

● switching to psychological treatment (CBT or IPT)

Pregnant or breastfeeding women who have a new episode of depression

1.4.8.4 For a woman who develops mild or moderate depression during pregnancy

or the postnatal period, the following should be considered:

● self-help strategies (guided self-help, C-CBT or exercise)

● non-directive counselling delivered at home (listening visits)

● brief CBT or IPT

1.4.8.5 Antidepressant drugs should be considered for women with mild

depres-sion during pregnancy or the postnatal period if they have a history ofsevere depression and they decline, or their symptoms do not respond to,psychological treatments

1.4.8.6 For a woman with a moderate depressive episode and a history of

depres-sion, or with a severe depressive episode during pregnancy or the tal period, the following should be considered:

postna-● structured psychological treatment specifically for depression (CBT orIPT)

● antidepressant treatment if the woman has expressed a preference for it

● combination treatment if there is no response, or a limited response topsychological or drug treatment alone, provided the woman under-stands the risks associated with antidepressant medication

Treatment-resistant depression

1.4.8.7 For pregnant women with treatment-resistant depression, a trial of a

differ-ent single drug or ECT should be considered before combination drugtreatment Lithium augmentation should be avoided

Generalised anxiety disorder (GAD)

This section should be read in conjunction with the NICE clinical guideline on themanagement of anxiety in primary, secondary and community care (see NICE[2004c] for details)

Women with GAD who are planning a pregnancy or pregnant

being treated with medication for GAD, the following should be considered:

● stopping medication and starting CBT if it has not already been tried

● if necessary, switching to a safer drug, if the decision is to maintainmedication

Women who have a new episode of GAD

1.4.8.9 A woman who has a new episode of GAD during pregnancy should be treated

according to the NICE guideline on anxiety, and CBT should be offered

Panic disorder

This section should be read in conjunction with the NICE clinical guideline on themanagement of anxiety in primary, secondary and community care (see NICE[2004c] for details)

Women with panic disorder who are planning a pregnancy or pregnant

1.4.8.10 If a woman is planning a pregnancy or becomes pregnant while being

treated for panic disorder, the following should be considered:

● stopping medication and starting CBT if it has not already been tried

● if necessary, switching to a safer drug, if the decision is to maintainmedication

Women who have a new episode of panic disorder

1.4.8.11 For women who have a new episode of panic disorder during pregnancy,

psychological therapy (CBT), self-help or C-CBT should be consideredbefore starting drug treatment

1.4.8.12 For women who have a new episode of panic disorder during pregnancy,

paroxetine should not be started and a safer drug should be considered

Obsessive–compulsive disorder

This section should be read in conjunction with the NICE clinical guideline on thetreatment and management of obsessive–compulsive disorder (OCD) (see NICE[2005c] for details)

Women with OCD who are planning a pregnancy or pregnant

1.4.8.13 A woman with OCD who is planning a pregnancy or pregnant should be

treated according to the NICE clinical guideline on OCD except that:

● if she is taking medication alone, stopping the drug and starting logical therapy should be considered

psycho-● if she is not taking medication, starting psychological therapy should beconsidered before drug treatment

● if she is taking paroxetine, it should be stopped and switching to a saferantidepressant considered

1.4.8.14 A pregnant woman with OCD who is planning to breastfeed should be treated

according to the NICE clinical guideline on OCD, except that the use of acombination of clomipramine and citalopram should be avoided if possible

Women who have a new episode of OCD while breastfeeding

1.4.8.15 A woman who has a new episode of OCD while breastfeeding should be

treated according to the NICE clinical guideline on OCD, except that thecombination of clomipramine and citalopram should be avoided because ofthe high levels in breast milk

Post-traumatic stress disorder

This section should be read in conjunction with the NICE clinical guideline on themanagement of post-traumatic stress disorder (PTSD) (see NICE [2005a] for details)

Women with PTSD who are planning a pregnancy or pregnant

1.4.8.16 A woman with PTSD who is planning a pregnancy or pregnant should be

treated according to the NICE clinical guideline on PTSD, except that ifshe is taking an antidepressant the drug should be stopped and trauma-focused psychological therapy (for example, CBT or eye movement desen-sitisation and reprocessing therapy) offered

1.4.8.17 For a woman with PTSD who is planning a pregnancy or pregnant,

adjunc-tive olanzapine should not be prescribed

Eating disorders

This section should be read in conjunction with the NICE clinical guideline on thetreatment and management of eating disorders (see NICE [2004b] for details)

Women with anorexia nervosa

1.4.8.18 A woman with anorexia nervosa who is planning a pregnancy, has an

unplanned pregnancy or is breastfeeding should be treated according to theNICE clinical guideline on eating disorders

Women with binge eating disorder

1.4.8.19 A woman with binge eating disorder who is taking an antidepressant and

is planning a pregnancy, has an unplanned pregnancy or is breastfeedingshould be treated according to the section on depression in this guideline(recommendations 1.4.8.1–7)

Women with bulimia nervosa

1.4.8.20 If a woman who is taking medication for bulimia nervosa is planning a

pregnancy or pregnant, healthcare professionals should consider graduallystopping the medication after discussion with her If the problem persists,referral for specialist treatment should be considered

Women who have an episode of bulimia nervosa while breastfeeding

1.4.8.21 If a woman has an episode of bulimia nervosa while breastfeeding,

psycho-logical treatment should be offered, rather than fluoxetine at 60 mg If awoman is already taking fluoxetine at 60 mg, she should be advised not tobreastfeed

Bipolar disorder

These recommendations are from the NICE clinical guideline on the management ofbipolar disorder (see NICE [2006] for details)

Pregnant women with bipolar disorder who are stable on an antipsychotic

1.4.8.22 If a pregnant woman with bipolar disorder is stable on an antipsychotic and

likely to relapse without medication, she should be maintained on theantipsychotic, and monitored for weight gain and diabetes

Women with bipolar disorder planning a pregnancy

1.4.8.23 If a woman who needs antimanic medication plans to become pregnant, a

low-dose typical or atypical antipsychotic should be the treatment ofchoice

1.4.8.24 If a woman with bipolar disorder planning a pregnancy becomes depressed

after stopping prophylactic medication, psychological therapy (CBT)should be offered in preference to an antidepressant because of the risk ofswitching to mania associated with antidepressants If an antidepressant isused, it should usually be an SSRI (but not paroxetine) and the womanshould be monitored closely

Women with bipolar disorder who have an unplanned pregnancy

1.4.8.25 If a woman with bipolar disorder has an unplanned pregnancy and is

stop-ping lithium as prophylactic medication, an antipsychotic should beoffered

Pregnant women with acute mania or depressive symptoms

Acute mania

1.4.8.26 If a pregnant woman who is not taking medication develops acute mania,

a typical or an atypical antipsychotic should be considered The doseshould be kept as low as possible and the woman monitored carefully

1.4.8.27 If a pregnant woman develops acute mania while taking prophylactic

medication, prescribers should:

● check the dose of the prophylactic agent and adherence

● increase the dose if the woman is taking an antipsychotic, or considerchanging to an antipsychotic if she is not

● if there is no response to changes in dose or drug and the patient hassevere mania, consider the use of ECT, lithium and, rarely, valproate.1.4.8.28 If there is no alternative to valproate, augmenting it with antimanic

medication (but not carbamazepine) should be considered

Depressive symptoms

1.4.8.29 For mild depressive symptoms in pregnant women with bipolar disorder

the following should be considered, in this order:

● self-help approaches such as guided self-help and C-CBT

● brief psychological treatments (including counselling, CBT and IPT).1.4.8.30 For moderate to severe depressive symptoms in pregnant women with

bipolar disorder the following should be considered:

● psychological treatment (CBT) for moderate depression

● combined medication and structured psychological treatments forsevere depression

1.4.8.31 If prescribing medication for moderate to severe depressive symptoms in a

pregnant woman with bipolar disorder, quetiapine alone, or SSRIs (but notparoxetine) in combination with prophylactic medication should be preferredbecause SSRIs are less likely to be associated with switching to mania thanthe tricyclic antidepressants Monitor closely for signs of switching and stopthe SSRI if the woman starts to develop manic or hypomanic symptoms

Care in the perinatal period

1.4.8.32 After delivery, if a woman with bipolar disorder who is not on medication

is at high risk of developing an acute episode, prescribers should considerestablishing or reinstating medication as soon as the woman is medicallystable (once the fluid balance is established)

1.4.8.33 If a woman maintained on lithium is at high risk of a manic relapse in the

immediate postnatal period, augmenting treatment with an antipsychoticshould be considered

Women with bipolar disorder who wish to breastfeed

1.4.8.34 Women with bipolar disorder who are taking psychotropic medication and

wish to breastfeed should be offered a prophylactic agent that can be usedwhen breastfeeding The first choice should be an antipsychotic

Schizophrenia

This section should be read in conjunction with the NICE clinical guideline on thetreatment and management of schizophrenia (see NICE [2002] for details)

Women with schizophrenia who are planning a pregnancy or pregnant

1.4.8.35 Women with schizophrenia who are planning a pregnancy or pregnant

should be treated according to the NICE clinical guideline on nia, except that if the woman is taking an atypical antipsychotic consider-ation should be given to switching to a low-dose typical antipsychotic,such as haloperidol, chlorpromazine or trifluoperazine

schizophre-Women with schizophrenia who are breastfeeding

1.4.8.36 A woman with schizophrenia who is breastfeeding should be treated

according to the NICE clinical guideline on schizophrenia, except thatwomen receiving depot medication should be advised that their infantsmay show extrapyramidal symptoms several months after administration

of the depot These are usually self-limiting

1.5.1.1 Clinical networks should be established for perinatal mental health

serv-ices, managed by a coordinating board of healthcare professionals,commissioners, managers, and service users and carers These networksshould provide:

● a specialist multidisciplinary perinatal service in each locality, whichprovides direct services, consultation and advice to maternity services,other mental health services and community services; in areas of highmorbidity these services may be provided by separate specialist perina-tal teams

● access to specialist expert advice on the risks and benefits ofpsychotropic medication during pregnancy and breastfeeding

● clear referral and management protocols for services across all levels ofthe existing stepped-care frameworks for mental disorders, to ensureeffective transfer of information and continuity of care

● pathways of care for service users, with defined roles and competenciesfor all professional groups involved

1.5.1.2 Each managed perinatal mental health network should have designated

specialist inpatient services and cover a population where there arebetween 25,000 and 50,000 live births a year, depending on the localpsychiatric morbidity rates

1.5.1.3 Specialist perinatal inpatient services should:

● provide facilities designed specifically for mothers and infants(typically with 6 –12 beds)

● be staffed by specialist perinatal mental health staff

● be staffed to provide appropriate care for infants

services

● have available the full range of therapeutic services

● be closely integrated with community-based mental health services toensure continuity of care and minimum length of stay

The Guideline Development Group has made the following recommendations forresearch, based on its review of evidence, to improve NICE guidance and patient care

in the future

to make decisions about their care

A randomised controlled trial should be conducted to compare usual care with usualcare plus the use of decision aids designed to help pregnant and breastfeeding womenwith mental disorders to make informed decisions about their care Outcomes shouldinclude the development of agreed care plans, the successful implementation of theagreed care plans, and satisfaction with the care plan and the communication aboutthe planning

Why this is important

Psychotropic drugs carry teratogenic risks during pregnancy and are often present inbreast milk It is therefore important that women are enabled to make informed deci-sions about treatment choices

of depression and/or anxiety

A randomised controlled trial should be conducted to compare the efficacy and costeffectiveness of an intervention for women with chronic subthreshold symptoms ofdepression and anxiety with usual maternity and primary care The interventionshould be a brief psychoeducational intervention Primary outcome measures mayinclude symptoms of depression and anxiety, and there should be a 1-year follow-upperiod

Why this is important

Depression and anxiety in the postnatal period can have a serious impact on awoman’s ability to cope with day-to-day life, including looking after her infant andother children in the family Even subthreshold symptoms can affect a woman’sgeneral functioning and the development of her infant Treating subthreshold

symptoms may prevent escalation of symptoms into a diagnosis of depression oranxiety, and also improve a woman’s ability to cope.

An evaluation of managed perinatal networks should be undertaken to compare theeffectiveness of different network models in delivering care It should cover thedegree of integration of services, the establishment of common protocols, the impact

on patients’ access to specified services and the quality of care, and staff views on thedelivery of care

Why this is important

Although only a relatively small number of women have a serious mental disorderduring pregnancy and the postnatal period, those who do may need specialist care,including access to knowledge about the risks of psychotropic medication, specialistinpatient beds and additional intrapartum care Managed clinical perinatal networksmay be a way of providing this level of care in a cost effective and clinically effectiveway by allowing access to specialist care for all women who need it, whether or notthey live near a specialist perinatal team

A study of the General Practice Research Database should be undertaken to assess the impact of pregnancy on changing psychotropic medication (including bothswitching and stopping medication) Outcomes should include relapse of mentaldisorders, exacerbation of symptoms, type and duration of treatment, and birthoutcomes

Why this is important

Most women with a mental disorder during pregnancy will be cared for in primarycare Knowing how pregnancy affects the pattern of psychotropic prescription wouldhelp to target educational campaigns for healthcare professionals caring for pregnantwomen

A validation study should be undertaken of the ‘Whooley questions’ (During the pastmonth, have you often been bothered by feeling down, depressed or hopeless? Duringthe past month, have you often been bothered by having little interest or pleasure indoing things?) in women in the first postnatal year, examining the questions’ effec-tiveness when used by midwives and health visitors compared with a psychiatricinterview

Why this is important

Depression in the first postnatal year is relatively common and may have a lastingimpact on the woman, her baby and other family members Case finding is mostconveniently undertaken by healthcare professionals in regular contact with women,but they do not traditionally have training in mental health The Whooley questionsappear to offer a relatively quick and convenient way of case finding for healthcareprofessionals who are not specialists in mental health

2 INTRODUCTION

This guideline has been developed to advise on the clinical management of and service provision for antenatal and postnatal mental health The guideline recommen-dations have been developed after careful consideration of the best available evidence

by a multidisciplinary team of healthcare professionals, women who have experiencedmental health problems in the antenatal or postnatal period and guideline methodolo-gists It is intended that the guideline will be useful to clinicians and service commis-sioners in providing and planning high-quality care for women with antenatal andpostnatal mental health problems while also emphasising the importance of theexperience of care for women and their families and carers

Clinical practice guidelines are ‘systematically developed statements that assistclinicians and patients in making decisions about appropriate treatment for specificconditions’ (Mann, 1996) They are derived from the best available research evidence,using predetermined and systematic methods to identify and evaluate all the evidencerelating to the specific condition in question Where evidence is lacking, the guidelineswill incorporate statements and recommendations based upon the consensus state-ments developed by the Guideline Development Group (GDG)

Clinical guidelines are intended to improve the process and outcomes of care in a number of different ways They can:

health-● provide up-to-date evidence-based recommendations for the management ofconditions and disorders by healthcare professionals

● be used as the basis to set standards to assess the practice of healthcare professionals

● form the basis for education and training of healthcare professionals

● assist patients and carers in making informed decisions about their treatment and care

● improve communication between healthcare professionals, patients and carers

● help identify priority areas for further research

Guidelines are not a substitute for professional knowledge and clinical judgement Theycan be limited in their usefulness and applicability by a number of different factors: theavailability of high-quality research evidence, the quality of the methodology used inthe development of the guideline, the generalisability of research findings and theuniqueness of individual patients

Although the quality of research in antenatal and postnatal mental health is able, the methodology used here reflects current international understanding on theappropriate practice for guideline development (AGREE: Appraisal of GuidelinesResearch and Evaluation Instrument; www.agreecollaboration.org), ensuring thecollection and selection of the best research evidence available and the systematicgeneration of treatment recommendations applicable to the majority of patients andsituations However, there will always be some patients for whom clinical guidelinerecommendations are not appropriate and situations in which the recommendationsare not readily applicable This guideline does not, therefore, override the individualresponsibility of healthcare professionals to make appropriate decisions in thecircumstances of the individual patient, in consultation with the patient and/or carer.

vari-In addition to the clinical evidence, cost-effectiveness information, where able, is taken into account in the generation of statements and recommendations ofthe clinical guidelines While national guidelines are concerned with clinical and costeffectiveness, issues of affordability and implementation costs are to be determined

avail-by the National Health Service (NHS)

In using guidelines, it is important to remember that the absence of empiricalevidence for the effectiveness of a particular intervention is not the same as evidencefor ineffectiveness In addition, of particular relevance in mental health, evidence-based treatments are often delivered within the context of an overall treatmentprogramme including a range of activities, the purpose of which may be to help engagethe patient and provide an appropriate context for the delivery of specific interventions

It is important to maintain and enhance the service context in which these interventionsare delivered, otherwise the specific benefits of effective interventions will be lost.Indeed, the importance of organising care, so as to support and encourage a good ther-apeutic relationship, is at times more important than the specific treatments offered

The National Institute for Health and Clinical Excellence (NICE) was established as aSpecial Health Authority for England and Wales in 1999, with a remit to provide a singlesource of authoritative and reliable guidance for patients, professionals and the public.NICE guidance aims to improve standards of care, to diminish unacceptable variations

in the provision and quality of care across the NHS and to ensure that the health service

is patient centred All guidance is developed in a transparent and collaborative mannerusing the best available evidence and involving all relevant stakeholders

NICE generates guidance in a number of different ways, two of which are vant here First, national guidance is produced by the Technology AppraisalCommittee to give robust advice about a particular treatment, intervention, procedure

rele-or other health technology Second, NICE commissions the production of nationalclinical practice guidelines focused upon the overall treatment and management of aspecific condition To enable this latter development, NICE established sevenNational Collaborating Centres in conjunction with a range of professional organisa-tions involved in healthcare

2.1.4 The National Collaborating Centre for Mental Health

This guideline has been commissioned by NICE and developed within the NationalCollaborating Centre for Mental Health (NCCMH) The NCCMH is led by a partnershipbetween the Royal College of Psychiatrists’ Research and Training Unit and the BritishPsychological Society’s equivalent unit (Centre for Outcomes Research and Effectiveness)

Once a national guideline has been published and disseminated, local healthcaregroups will be expected to produce a plan and identify resources for implementation,along with appropriate timetables Subsequently, a multidisciplinary group involvingcommissioners of healthcare, primary care and specialist mental health professionals,patients and carers should undertake the translation of the implementation plan intolocal protocols The nature and pace of the local plan will reflect local healthcareneeds and the nature of existing services; full implementation may take a consider-able time, especially where substantial training needs are identified

This guideline identifies key areas of clinical practice and service delivery for local andnational audit Although the generation of audit standards is an important and necessarystep in the implementation of this guidance, a more broadly based implementation strat-egy should be developed Nevertheless, it should be noted that the Healthcare Commissionwill monitor the extent to which Primary Care Trusts (PCTs), trusts responsible for mentalhealth and social care, and Health Authorities have implemented these guidelines

MENTAL HEALTH GUIDELINE

The GDG was convened by the NCCMH and supported by funding from NICE TheGDG consisted of two former service users, professionals from psychiatry, clinicalpsychology, general practice, midwifery, obstetrics, health visiting, social work serv-ices and management

Staff from the NCCMH provided leadership and support throughout the process

of guideline development, undertaking systematic searches, information retrieval,appraisal and systematic review of the evidence Members of the GDG received train-ing in the process of guideline development The National Guidelines Support andResearch Unit, also established by NICE, provided advice and assistance regardingaspects of the guideline development process

All members of the group made formal declarations of interest at the outset,updated at every GDG meeting GDG members met a total of 15 times throughout theprocess of guideline development For ease of evidence identification and analysis,some members of the GDG became topic leads, covering identifiable treatmentapproaches The NCCMH technical team supported group members, with additionalexpert advice from special advisers where necessary All statements and recommen-dations in this guideline have been generated and agreed by the whole GDG.

This guideline will be of relevance to all women who suffer from antenatal and natal mental health problems

post-The guideline covers the care provided by primary, secondary, tertiary and otherhealthcare professionals who have direct contact with, and make decisions concern-ing, the care of women with mental disorder in the antenatal and postnatal period.Although this guideline will briefly address the issue of diagnosis, it will not makeevidence-based recommendations or refer to evidence regarding diagnosis, primaryprevention or assessment In sum, the guideline is intended for use by:

● Professional groups who share in the treatment and care for women with a nosis of antenatal and postnatal mental health problems, including psychiatrists,clinical psychologists, mental health nurses, community psychiatric nurses(CPNs), other community nurses, general practitioners (GPs), midwives, obstetri-cians, health visitors, social workers, counsellors, practice nurses, occupationaltherapists, pharmacists and others

diag-● Professionals in other health and non-health sectors who may have direct contactwith or are involved in the provision of health and other public services for thosediagnosed with antenatal and postnatal mental health problems; these may includeaccident and emergency staff, paramedical staff, prison doctors, the police andprofessionals who work in the criminal justice and education sectors

● Those with responsibility for planning services for people with a diagnosis ofantenatal and postnatal mental health problems, and their carers, including direc-tors of public health, NHS trust managers and managers in PCTs

The guideline makes recommendations for pharmacological treatments and the use ofpsychological and service-level interventions Specifically it aims to:

● evaluate the role of specific pharmacological agents in the treatment and ment of antenatal and postnatal mental health problems

manage-● evaluate the role of specific psychological interventions in the treatment andmanagement of antenatal and postnatal mental health problems

● evaluate the role of specific service-delivery systems and service-level tions in the management of antenatal and postnatal mental health problems

interven-● integrate the above to provide best-practice advice on the care of individuals with

a diagnosis of antenatal or postnatal mental health problems through the differentphases of illness, including the initiation of treatment, the treatment of acuteepisodes and the promotion of recovery

● consider economic aspects of various standard treatments for antenatal andpostnatal mental health problems

The guideline will not cover treatments that are not normally available on the NHS

There are other versions of Antenatal and Postnatal Mental Health: Clinical Management and Service Guidance, including:

● the NICE guideline, which is a shorter version of this guideline, containing thekey recommendations and all other recommendations

● the Quick Reference Guide, which is a summary of the main recommendations inthe NICE guideline

● Understanding NICE Guidance, which describes the guidance using non-technicallanguage It is written chiefly for patients but may also be useful for family members,advocates or those who care for women with antenatal and postnatal mental healthproblems

The guideline is divided into chapters, each covering a set of related topics The firstthree chapters provide a summary of the clinical practice and research recommenda-tions and a general introduction to guidelines and to the methods used to developthem The fourth chapter provides an introduction to the topic of antenatal andpostnatal mental health Chapters 5 to 8 describe the evidence that underpins therecommendations

Where appropriate, details about current practice, the evidence base and anyresearch limitations are provided Information is also given about both the interven-tions included and the included studies where appropriate Summary evidence profilesare also provided Clinical summaries bring the evidence together highlighting keyissues Recommendations related to each topic are presented at the end of the relevantsection of the chapter The CD-ROM which accompanies this publication includesfuller details of the included studies plus the excluded studies and reasons for exclu-sion, the full evidence profiles, and the forest plots (see below for details)

Appendices on CD-ROM

3 METHODS USED TO DEVELOP

THIS GUIDELINE

The development of this guideline drew upon methods outlined by NICE (Guideline Development Methods: Information for National Collaborating Centres and

represen-tatives and technical experts known as the GDG, with support from the NCCMHstaff, undertook the development of a patient-centred, evidence-based guideline.There are six basic steps in the process of developing a guideline:

● define the scope, which sets the parameters of the guideline and provides a focusand steer for the development work

● define clinical questions considered important for practitioners and service users

● develop criteria for evidence searching and search for evidence

● design validated protocols for systematic review and apply to evidence recovered

Guideline topics are selected by the Department of Health (DH) and the WelshAssembly Government, which identify the main areas to be covered by the guideline

in a specific remit (see The Guideline Development Process – An Overview for

was translated into a scope document by staff at the NCCMH

The purpose of the scope was to:

● provide an overview of what the guideline would include and exclude

● identify the key aspects of care that must be included

● set the boundaries of the development work and provide a clear framework toenable work to stay within the priorities agreed by NICE and the NCCMH and theremit from the DH/Welsh Assembly Government

● inform the development of the clinical questions and search strategy

● inform professionals and the public about the expected content of the guideline

● keep the guideline to a reasonable size to ensure that its development could becarried out within an 18-month period

The draft scope was subject to consultation with stakeholders over a 4-weekperiod During the consultation period, the scope was posted on the NICE website(www.nice.org.uk) Comments were invited from stakeholder organisations and theGuideline Review Panel (GRP) Further information about the GRP can also be found

on the NICE website The NCCMH and NICE reviewed the scope in light ofcomments received, and the revised scope was signed off by the GRP

The GDG was made up of professionals in psychiatry, clinical psychology,midwifery, health visiting, social work and general practice, together with two formerservice users The guideline development process was supported by staff from theNCCMH, who undertook the clinical and health economics literature searches,reviewed and presented the evidence to the GDG, managed the process andcontributed to drafting the guideline

Fifteen GDG meetings were held between 18 November 2004 and 29 September

2006 During each day-long GDG meeting, in a plenary session, clinical questionsand clinical and economic evidence were reviewed and assessed, and recommenda-tions formulated At each meeting, all GDG members declared any potential conflict

of interest, and service-user concerns were routinely discussed as part of a standingagenda

The GDG divided its workload along clinically relevant lines to simplify the guidelinedevelopment process, and GDG members formed smaller topic groups to undertakeguideline work in that area of clinical practice Topic Group 1 covered questions relat-ing to pharmacological aspects of management of antenatal and postnatal mental healthproblems; Topic Group 2 covered the prediction and detection of mental disorder; Topic

Group 3 covered psychology and psychosocial interventions; and Topic Group 4covered service delivery These groups were designed to efficiently manage the largevolume of evidence appraisal prior to presenting it to the GDG as a whole Each topicgroup was chaired by a GDG member with expert knowledge of the topic area (one ofthe healthcare professionals) Topic groups refined the clinical questions, refined theclinical definitions of treatments, reviewed and prepared the evidence with the system-atic reviewer before presenting it to the GDG as a whole and helped the GDG to iden-tify further expertise in the topic Topic-group leaders reported the status of the group’swork as part of the standing agenda They also introduced and led the GDG discussion

of the evidence review for that topic and assisted the GDG Chair in drafting that section

of the guideline relevant to the work of each topic group

Individuals with direct experience of services gave an integral service-user focus tothe GDG and the guideline The GDG included two service users They contributed

as full GDG members to writing the clinical questions, helping to ensure that theevidence addressed their views and preferences, highlighting sensitive issues andterminology relevant to the guideline and bringing service-user research to the atten-tion of the GDG In drafting the guideline, they contributed to identifying recommen-dations from the service-user perspective In addition, testimonies were collectedfrom other service users and healthcare professionals (see Section 3.8)

Special advisers, who had specific expertise in one or more aspects of treatment andmanagement relevant to the guideline, assisted the GDG, commenting on specificaspects of developing the guideline and making presentations to the GDG Appendix

2 lists those who agreed to act as special advisors

A consensus conference was held during the guideline development period in oration with the GDG developing the NICE guideline for the treatment and manage-ment of bipolar disorder This was to discuss the use of psychotropic medicationbefore, during and after pregnancy with invited experts from outside of the GDG, whogave presentations and commented on a draft position statement which formed thebasis of Chapter 7 Invited experts are listed in Appendix 2

collab-Towards the end of the guideline development process, a focus group was heldwith healthcare professionals from primary care (GPs, health visitors and midwives)

to aid understanding of how the guideline will impact on primary care in order tofacilitate writing the quick reference guide (see Section 2.2.4)

3.4 CLINICAL QUESTIONS

Clinical questions were used to guide the identification and interrogation of theevidence base relevant to the topic of the guideline Before the first GDG meeting,draft questions were prepared by NCCMH staff based on the scope and anoverview of existing guidelines and modified during a meeting with the guidelineChair They were then discussed by the GDG and amended as necessary Whereappropriate, the questions were refined once the evidence had been searched and, where necessary, sub-questions were generated Questions submitted bystakeholders were also discussed by the GDG and the rationale for not includingquestions was recorded in the minutes The final list of clinical questions is inAppendix 5

For questions about interventions, the patient, intervention, comparison andoutcome (PICO) framework was used This structured approach divides each questioninto four components: the patients (the population under study), the interventions (what

is being done), the comparisons (other main treatment options) and the outcomes (themeasures of how effective the interventions have been) (see Text Box 1)

For questions relating to diagnosis, the PICO framework was not used, as such questions do not involve an intervention designed to treat a particular condition.Rather, the questions were designed to pick up key issues specifically relevant

to diagnostic tests, for example their accuracy, reliability, safety and acceptability tothe patient

interested in? How can they be best described? Are there subgroups that need to be considered?

be used?

with the intervention?

outcomes should be considered: intermediate or short-term measures, mortality, morbidity and treatment complications, rates of relapse, late morbidity and readmission, return to work, physical and social functioning and other measures such as quality of life, general health status and costs?

Text Box 1: Features of a well-formulated question on intervention

effectiveness – the PICO guide

In some situations, the prognosis of a particular condition is of fundamentalimportance over and above its general significance in relation to specific interven-tions Areas where this is particularly likely to occur relate to assessment of risk, forexample in terms of behaviour modification or screening and early intervention Inaddition, questions related to issues of service delivery are occasionally specified inthe remit from the DH/Welsh Assembly Government In these cases, appropriate clin-ical questions were developed to be clear and concise.

To help facilitate the literature review, a note was made of the best study-designtype to answer each question There are four main types of clinical questions of rele-vance to NICE guidelines These are listed in Text Box 2 For each type of question,the best primary study design varies, where ‘best’ is interpreted as ‘least likely to givemisleading answers to the question’

However, in all cases, a well-conducted systematic review of the appropriate type

of study is likely to always yield a better answer than a single study

Deciding on the best design type to answer a specific clinical or public healthquestion does not mean that studies of different design types addressing the samequestion were discarded

Effectiveness or other impact Randomised controlled trial (RCT); other

absence of an RCT are the following: internally/externally controlled before-and-after trial, interrupted time series

(for example, risk factor, valid gold standard in a randomised trial

Rates (of disease, patient Cohort, registry, cross-sectional studyexperience, rare side effects)

Text Box 2: Best study design to answer each type of question

The aim of the clinical literature review was to systematically identify and synthesiserelevant evidence from the literature in order to answer the specific clinical questionsdeveloped by the GDG Thus, clinical practice recommendations are evidence based,where possible, and if evidence was not available, informal consensus methods wereused (see Section 3.5.6) and the need for future research was specified

3.5.1 Methodology

A stepwise, hierarchical approach was taken to locating and presenting evidence to

the GDG The NCCMH developed this process based on methods set out in Guideline Development Methods: Information for National Collaborating Centres and

a range of other sources These included:

Department (Australia)

● Clinical Evidence

● The Cochrane Collaboration

● New Zealand Guidelines Group

● NHS Centre for Reviews and Dissemination

● Oxford Centre for Evidence-Based Medicine

● Scottish Intercollegiate Guidelines Network (SIGN)

● United States Agency for Healthcare Research and Quality

After the scope was finalised, a more extensive search for systematic reviews andpublished guidelines was undertaken

The GDG decided which questions were likely to have a good evidence base andwhich questions were likely to have little or no directly relevant evidence In theabsence of good evidence, recommendations were developed by informal consensus.For questions that were unlikely to have a good evidence base, a brief descriptivereview was initially undertaken by a member of the GDG (see Section 3.5.6) Forquestions with a good evidence base, the review process depended on the type of clinical question

Searches for evidence were updated between 6 and 8 weeks before the first tation After this point, studies were included only if they were judged by the GDG to

consul-be exceptional (for example, the evidence was likely to change a recommendation)

The search process for questions concerning interventions

For questions related to interventions, the initial evidence base was formed from conducted RCTs that addressed at least one of the clinical questions Although thereare a number of difficulties with the use of RCTs in the evaluation of interventions inmental health, the RCT remains the most important method for establishing treatmentefficacy (this is discussed in more detail in appropriate clinical evidence chapters).For other clinical questions, searches were for the appropriate study design (seeabove)