Evaluation of Lay Support In Pregnant women with Social ... · differences in age, socioeconomic or smoking status, body mass index or parity. This study further highlighted the importance

Version 6 11th October 2011 1

Evaluation of Lay Support In Pregnant women with Social risk: a randomised controlled trial

(The ELSIPS Trial)

Redesigned maternity support services for multi-ethnic disadvantaged groups:

CLAHRC BBC: Theme 5

October 2011 Version 6

Christine MacArthur Karla Hemming

Lucy Ingram Kate Jolly

Sara Kenyon


Chief Investigator Christine MacArthur Professor of Maternal and Child Epidemiology School of Health and Population Sciences University of Birmingham Edgbaston B15 2TT Sponsoring Organisation University of Birmingham Funder NIHR-CCF PO Box 407 Teddington Middlesex TW11 0XX ISRCTN Number ISRCTN35027323 MREC Number: 10/H1207/23 Sponsor reference Number RG_10-017


Contents Background ............................................................................................................... 4

Methods .................................................................................................................... 6

Design .................................................................................................................... 6 Setting and population ............................................................................................ 6 Usual care (Control) ................................................................................................ 7 Intervention ............................................................................................................. 7 Eligibility .................................................................................................................. 7

Inclusion criteria .................................................................................................. 7 Exclusion criteria ................................................................................................. 8

Recruitment ............................................................................................................ 8 Outcome measures ................................................................................................. 9

Secondary outcomes ........................................................................................... 9 Longer term infant outcomes ............................................................................... 9 Psychological outcomes ...................................................................................... 9

Data collection ...................................................................................................... 10 Primary outcomes ............................................................................................. 10 Secondary outcomes ......................................................................................... 10 Additional data and process items ..................................................................... 10 Response to the postal questionnaire ................................................................ 11

Sample size .......................................................................................................... 12 Pilot Phase ........................................................................................................... 14 Numbers of women eligible ................................................................................... 14 Minimisation of bias .............................................................................................. 14 Loss to follow up ................................................................................................... 14 Statistical analysis................................................................................................. 15 Data monitoring .................................................................................................... 15

Qualitative component to the ELSIPS study. ........................................................... 16

Data Collection Methods ....................................................................................... 16 Consent to participate ........................................................................................... 17 Data Analysis ........................................................................................................ 17

Ethics ...................................................................................................................... 18

Declaration of Helsinki .......................................................................................... 18 Guidelines for Good Clinical Practice (GCP) ..................................................... 18 Withdrawal criteria ............................................................................................. 18 Independent Ethics Committee .......................................................................... 18 Participant confidentiality ................................................................................... 18

Assessment of safety .............................................................................................. 18

Quality control and quality assurance procedures ................................................... 19

Site set-up and training ......................................................................................... 19 Data processing and monitoring............................................................................ 19 Direct access to source data/documents ............................................................... 19 Monitoring data quality .......................................................................................... 19 Data handling and record keeping ........................................................................ 20

Funding ................................................................................................................... 20

Project Management ............................................................................................... 21

Risk assessment ..................................................................................................... 22

Insurance and indemnity ......................................................................................... 22

Publication policy ..................................................................................................... 22

History of Amendments to Protocol ......................................................................... 24

References .............................................................................................................. 26


Background Maternal, neonatal and child health outcomes are poorer in women from multi-ethnic disadvantaged

groups and there are a range of factors likely to be contributing, one of these being inclusivity and

engagement with services. This was an important focus of the National Service Framework (NSF)1 on

Maternity and Maternity Matters,2 both of which emphasise choice, access and continuity of care in a

safe service. The last two Confidential Enquiries into Maternal Deaths and Saving Mother’s Lives made

recommendations about care for vulnerable women with socially complex lives.3 Social disadvantage,

living in a poor community and being from a minority ethnic group, including asylum seekers and newly

arrived refugees, were all major risk factors. Black African women, including asylum seekers and newly

arrived refugees had a mortality rate nearly six times higher than White women.3. Clearly maternal death

is rare but it is well documented that women from these vulnerable groups book for antenatal care later,

make fewer visits, experience greater pregnancy morbidity and have a higher risk of adverse fetal and

child health outcomes. A recent UK national cohort study4

found severe maternal morbidities were

significantly more common among women from black African and Caribbean and Pakistani ethnic groups

than in white women. The authors suggested that these differences may be due to pre-existing medical

factors or factors related to care during pregnancy, labour or birth but they are unlikely to be due to

differences in age, socioeconomic or smoking status, body mass index or parity. This study further

highlighted the importance of tailored maternity services and improving access to care for women of

ethnic minorities. Based on the assumption that increased engagement with antenatal services will

result in improved maternal and perinatal health outcomes, the maternity NSF recommended that

services are proactive in engaging all women, particularly those from disadvantaged groups. This

includes contact early in their pregnancy and maintenance of contact before and after birth. It notes that

some women in these groups may require more support and access to social or other services, e.g.,

housing, benefits advice.

In informing the NSF, evidence was sought on how services may be organised and delivered to improve

outcomes for disadvantaged groups, but little good evidence was found.5 The National Institute for

Clinical Excellence (NICE) are currently developing a Guideline for Models of Service Provision for

pregnant women with complex social factors6

. This was published in September 2010 and found little

high quality evidence. One of the research recommendations was to answer the question ‘Is intervention

and/or family support provided by statutory and 3rd sector agencies effective in improving outcomes for

women and their babies?’

Additional social support during pregnancy for vulnerable groups might, on the face of it, be of possible

benefit. However, a recently updated Cochrane review of ‘Support during pregnancy for women at

increased risk of low birth weight (LBW)7 found 18 RCTs and concluded that programmes offering

additional social support were not associated with improvements in any perinatal outcomes. In most of

the trials, however, participants were selected because they had obstetric rather than social risks for

LBW and almost all interventions were delivered by trained professionals, which may not be the most


likely person to improve outcomes. The review did find an overall reduction in Caesarean section (RR

0.88, 95%CI 0.79 to 0.98), and noted that some trials found improvements in maternal psychosocial

outcomes.7 It is well documented that a reduction in maternal depression, in addition to improving

maternal wellbeing, will have a beneficial effect on short and long term child outcomes.8,9

There is some evidence on benefits of lay support in other areas of maternity care from the Cochrane

review on Continuous Support for Women during Childbirth,10

which suggested that the beneficial effects

associated with continuous support were even greater when the provider was not a member of the

hospital staff. The review showed that when the providers of continuous support were members of staff,

spontaneous vaginal birth (SVB) was increased. When the providers of support were not staff members

SVB appeared to be further increased.

Evidence from three much quoted US trials by Olds, of nurse home visitation from pregnancy up to 2

years for vulnerable groups (one mainly teen, single mothers11 and the second, young deprived African-

Americans12) found improvements in some pregnancy-related outcomes, including greater engagement

with maternity and related services, and went on to find beneficial effects in several long-term maternal

and child outcomes. Only the first trial, however, found any effect on preterm delivery and birth weight

and only in the small sub-groups of those aged 14-16 and of smokers.11 The third trial by Olds also

examined the effects of home visitation by lay workers but found no benefit from this type of worker.13

Evaluation of the Old’s support model of nurse home visitation is currently being undertaken throughout

the UK (Family Nurse Partnership).

At present therefore, there is little evidence on whether lay support improves maternal and infant

outcomes among multi-ethnic groups of women with complex social needs in the UK. A recent meta-

synthesis14

into barriers to antenatal care for marginalised women in high income countries has

suggested that a non-judgemental, contextually tailored antenatal service that pays attention to the

specific circumstances of disadvantaged women may increase sustained access to care. So at least in

theory, care that provides individual case management including home visiting, as provided by a

Pregnancy Outreach Worker (POW) service, could be of benefit.

The aim of this study is to evaluate a POW service for nulliparous women identified as having social risk

within a maternity service that is systematically assessing social risks alongside the usual obstetric and

medical risks.


Methods Design The study design is a randomised controlled trial involving three primary care trusts, with nulliparous

women assessed as having social risk and who give consent, randomised to standard maternity care or

the addition of referral to the POW support service.

Setting and population The POW service and its evaluation will run across the whole of Birmingham, which currently comprises

three Primary Care Trusts (PCTs): Heart of Birmingham (HoB PCT); South Birmingham (SB PCT) and

Birmingham East and North (BEN PCT). Although varying in proportion, these PCTs all include a

population that has high levels of deprivation and with a variety of ethnic groups, including many recently

arrived mothers, refugees and asylum seekers. For example, in HoB PCT there are 5500-6000 births

each year; almost 90% of which are to women in areas of the highest Index of Multiple Deprivation

scores (IMD 2004).15

Only about 15% are of European ethnicity, 54% are within the South Asian group

(31% Pakistani, 11% Bangladeshi and 9% Indian), 13% are African and 10% African-Caribbean. One in

four mothers has themselves been born outside the UK and many are recent immigrants who have little

English language skills. In SB PCT, about 50% of births occur to women in the most deprived quintile of

deprivation (IMD) and 60% of mothers are white. BEN PCT has a population somewhere between these

in terms of the proportion of women in the ethnic minority groups and levels of deprivation. In summary,

women from multi-ethnic groups with complex social risk and needs accounts for a large and increasing

proportion of the maternity population cared for by the three Maternity Units (Birmingham Women’s NHS

Foundation Trust, Sandwell & West Birmingham NHS Trust, and Heart of England NHS Foundation

Trust) in these PCTs.

To maximise access and engagement with maternity services the local PCTs have commissioned a new

service model based on social risk assessment. This will be alongside assessing and managing

obstetric and medical risk in the usual way. To assess social risk a set of items have recently been

included in the standardised maternity notes used universally in Birmingham. These are completed at

the booking visit by the midwife and identify whether a woman has any of the following factors:

• UK resident for under a year. • Difficulty with the English language, both spoken and written. • Housing problems, such as rent arrears, temporary accommodation, registered with National

Asylum Support Service (NASS) or of No Fixed Abode (NFA). • No support from either partner or family or friend • Woman/household member in receipt of social services support, including child protection. • Identified benefit problem. • Smoking. • Drug misuse, including other’s in the household. • Alcohol misuse. • Clinical diagnosis of past or present mental illness. • Teen parent (under 20 years old). • Domestic abuse.


• BMI less than or equal to 18 OR more than or equal to 35. • Late booking (defined as booking after 18 weeks gestation). • DNA 2 or more antenatal appointments (under 28 weeks gestation).

The intention is that systematic social risk assessment will maximise the likelihood that social risk is

identified and needs are met. The PCTs have also decided to provide a pregnancy outreach worker

(POW) service to complement these pathways, with the intention of further increasing full engagement

with care during pregnancy and postpartum, and to improve the women’s social conditions. The ultimate

aim of this, theoretically at least, is to improve the health of both mother and baby by increasing

engagement with antenatal services, which should reduce perinatal mortality and morbidity. It is also

hoped that additional support of this nature would improve women’s psychological health, which in turn

would have a positive impact on the child.

Usual care (Control) Midwives identifying women with social risk factors currently either signpost women to services that may

be beneficial or refer them to specialised agencies or personnel. This may mean they signpost to

support agencies (for example, housing or benefit offices) or refer to other agencies (for example, social

services), or refer onto the specialist midwives in their Trust. These specialist midwives act as a contact

point and provide specific advice and support for women experiencing problems such as domestic

abuse, mental health issues or who are teenagers when they are pregnant.

Intervention The POW service is in addition to standard maternity care and will not be available to nulliparous women

other than within the trial, since its effectiveness is not known. Women assessed as having social risk

and randomised to the intervention group will be referred to a POW who will provide individual case

management including home visiting. The purpose of the POW service is to ensure that women attend

antenatal appointments and engage with required care, such as taking prescribed medication, attending

scan appointments, and including making lifestyle changes, such as smoking cessation. The POWs also

provide social support on such issues as ensuring that available benefits are obtained, housing

difficulties are dealt with, mental health problems managed and overall well-being is maximised. The

philosophy underlying POW support is an attempt to help women to become more able to manage

problems that arise in life, i.e., to enhance their general self-efficacy. The POWs receive appropriate

training to NVQ level 3 which is provided by ‘Gateway Family Services’ and have access to supervision

from experts with specific skills and knowledge. Postpartum POW contact will continue until 6 weeks

after birth when transfer to the Family Support Worker (FSW) would take place for those who require it.

Eligibility Inclusion criteria

• Nulliparous women < 28 weeks gestation.

• Assessed by the midwife as having specified social risk through systematic assessment.


Nulliparous is defined as never having given birth to a child; this will include women who have had a

miscarriage/s or termination/s of pregnancy. We have chosen under 28 weeks as an inclusion criterion

to give adequate time for the POW service to impact on the outcomes.

Exclusion criteria One of the PCTs (South) participating in this trial is also involved in a national trial of additional support

to pregnant teenagers, called the Family Nurse Partnership (FNP). The FNP intervention is health

professionals providing intensive support throughout pregnancy up to 2 years after birth. We will exclude

teenagers recruited to FNP, but do not expect this to greatly affect recruitment to ELSIPS. We will also

exclude those under 16 years of age due to the complexity of gaining informed consent from this group.

The original intention of the ELSIPS trial was to include all pregnant women. However, our detailed

investigations of current social support within the PCTs have found that many multiparous women with

high social need will already have been allocated a FSW through their local Children’s Centre. This is

because multiparous women access the Children Centres for services for their children under 5 years

old and so come into contact with the FSW on a regular basis. These FSWs are provided through local

education, as well as health services funding, and many provide very similar support to a POW. The

main distinction between FSWs and POWs is the FSWs do not specifically engage with nulliparous

women in the antenatal period. On this basis if multiparae were included, the trial comparison may fail to

find a real difference because of the dilution effect of FSWs. In addition, contamination may arise if

systematically more multiparae randomised to standard care who did not already have a FSW were

subsequently provided with one because of not having been allocated to a POW.

Recruitment As part of the booking visit, all women have a systematic social risk assessment undertaken by the

midwife. Once social risk has been identified the midwife will offer the support routinely available (as

part of standard care) and will discuss the additional support of the POW only available through the trial.

If the woman is potentially interested in taking part, her details will be passed to the ELSIPS midwife

within the community midwifery team and the woman will be given both the full and summary Participant

Information Leaflets. The ELSIPS midwife will then contact the women and arrange to see her to explain

the study and answer any questions she may have. The ELSIPS midwife will receive additional training

and support from the University of Birmingham team to undertake this role. Women will be asked if they

would prefer to be contacted by telephone to complete the questionnaire at 8-12 weeks after birth.

Randomisation to the POW service will take place using a dedicated telephone system, once written

consent has been obtained. Randomisation will stratify for the three Maternity Trusts, with random block

sizes.


Outcome measures The primary outcomes have been chosen on the basis that they are linked to maternal and infant

health. The two primary outcomes are engagement with antenatal care, assessed based on number of

antenatal visits, and maternal depression, assessed using the Edinburgh Postnatal Depression Scale16

(EPDS) at 8-12 weeks after birth.

Secondary outcomes Maternal outcomes will include:

• length of labour (first, second and third stages), • mode of birth (spontaneous vaginal birth, instrumental birth or caesarean section), • perineal trauma (episiotomy, degree of laceration), • incidence of possible maternal morbidity (e.g., postpartum haemorrhage, shoulder dystocia,

chorionamnioitis), • length of stay in hospital, • engagement with other services, as required (e.g., smoking cessation service).

Baby outcomes are mainly markers of poor perinatal outcome

• composite outcome of adverse perinatal outcome comprising: o perinatal mortality; o preterm birth before 34 weeks; o birth weight 10th centile or below; o admission to neonatal unit

• Apgar score at 5 minutes, • arterial cord blood gases, if taken • breastfeeding initiation rate, • length of stay in hospital, • oxygen at 36 weeks post conceptual age, if applicable, • retinopathy of prematurity, if applicable, • abnormal cerebral ultrasound prior to discharge (e.g., intraparenchymal cerebral bleed,

hydrocephalus, parenchymal cysts), if applicable, • necrotising enterocolitis (Bells Stage I, II or III), if applicable, • culture positive sepsis requiring greater than 5 days antibiotic treatment, if applicable.

Longer term infant outcomes

• Routine child health assessments, including immunisation uptake and breastfeeding continuation at 6 weeks.

Psychological outcomes

• Self efficacy (using Pearlin and Schooler Mastery Scale17

• Mother-to-infant bonding tool.).

18

While additional and longer term psychological assessment may be desirable for these women, we have

limited the assessments we intend to undertake because contact with these women may be harder than

usual to maintain and they may not reply to multiple questionnaires.

We have chosen to evaluate self-efficacy as one of the psychological outcomes rather than self-esteem

as it is more closely related to the changes the POWs are intended to facilitate. Self-esteem is believed

to reflect evaluation of one’s overall self-worth, while self-efficacy is specifically concerned with


evaluation of one’s performance.19

We have chosen to evaluate differences in general self-efficacy

rather than parenting specific efficacy because it is this broad construct that we believe will be promoted

by the POWs.

The detrimental impact of maternal bonding difficulties on both the emotional and cognitive development

of the child and the quality of the mother-infant relationship has been well documented in the literature.20

We have therefore chosen to evaluate mother-to-infant bonding.

Data collection Primary outcomes Data on number of antenatal visits is collected routinely. The number of community midwifery

appointments per women will be obtained from West Midlands Perinatal Institute (WMPI). Each hospital

has a record of the outpatient appointments attended, which can be sourced via each IT department.

The data from WMPI and the hospitals will be linked.

The EPDS will be collected from women 8-12 weeks after birth, after the POW service has finished.

Initially, the questionnaire containing the EPDS will be sent by post. Non-responder contact details will

be checked first with the midwife who cared for them, then using routine postnatal systems (health

visitors, GPs). Should women need assistance with completing the questionnaire it will be undertaken

by someone blinded to trial allocation. The sample size calculation has allowed for a cautious 20% drop-

out in collection of this data, since higher levels of response may be challenging in this group.

Secondary outcomes

• Data on maternal and perinatal morbidity and mortality will be collected from routine data sources from all hospitals. Data on babies receiving care in NCIU will be obtained via the Badger data collection system, which all the hospitals use.

• Assessment of maternal self-efficacy17 and mother-infant bonding18 will be undertaken between 8-12 weeks after birth at the same time as the EPDS, using the same pathways.

• Within the PCTs Child Health Services, routine data is collected regarding child health assessments, breastfeeding continuation rates and immunisation uptake and these will be obtained from this source.

Additional data and process items

• Maternal and baby demographic characteristics Mother: age, ethnicity, deprivation score from post code. Baby: sex, birth weight, gestation.

• Specific social risk factors identified. • Identified existing obstetric or medical risk. • Possible use of non-POW support workers (using the E Start system used by the Children

Centres). • Whether contact with the POW was established. • Number and nature of contacts with POW.


Response to the postal questionnaire We suspect that this group of women will be challenging to obtain a high response to the postal

questionnaire. As one of our primary outcomes is contained within the questionnaire, we intend to

maximise the chances of a response using the most effective methods available. The recently updated

Cochrane review21

on ‘Methods to increase response to postal and electronic questionnaires’ suggests a

number of strategies are effective.

The odds of response were at least doubled using

• monetary incentives, • recorded delivery.

The odds of response were substantially higher with

• pre-notification, • follow-up contact, • providing a second copy of the questionnaire at follow up.

To maximise the response rate, and therefore improve the scientific validity and reliability of the study,

we intend to provide a small incentive to participants in the questionnaire to thank them for their time

completing it. This will be a ‘High Street’ voucher for £5 which can be spent in many high street stores.

We believe a higher proportion of these women will have moved within the first month following birth and

therefore intend to use ‘Recorded Delivery’ so that those that do not reach their intended recipient will be

returned to the Trial Office, thereby informing us that they are no longer there and minimising the number

of vouchers wasted. Women will also be notified that the questionnaire will be coming and a copy of the

questionnaire will always be provided.

We intend contact to be as follows

• When we are informed by the collaborating Trusts that the mother has given birth (approximately

2 weeks after birth) we will send a ‘Congratulations’ card to the woman with a reminder that the

questionnaire will be coming at 8 weeks after birth. A ‘change of address’ card will be included.

Where requested, arrangements for telephone completion will be confirmed.

• Prior to the questionnaire being sent, a letter will be sent to the GP to ensure that contact is

appropriate.

• At 8 weeks after birth the questionnaire (containing voucher) will be sent with an appropriate

accompanying letter (which identifies whether the baby has been discharged home with the

mother, is in the neonatal unit or has sadly died). Where requested, this will be done by

telephone. For women whose babies have died telephone completion will not be done, as it was

not felt to be appropriate – they will initially be contacted by letter.

• If no response is obtained a reminder phone call or SMS text will be sent. If no phone number is

available a letter will be sent.

• At recruitment women give us a friend/relative as an additional contact point. We will contact this

person to check the woman’s contact details. This will not involve an additional contact with the

women.


• If no response is obtained the ELSIPS midwife will check with the Primary Care Team whether

the contact address is correct and who is the lead Healthcare Professional (HCP) for that mother

(usually the Health Visitor).

• A final contact will be made via the ELSIPS midwife or lead HCP(whichever is most appropriate).

Women who score 2 or 3 on the EPDS question 10 (suicidal ideation) will be contacted by a member of

the research team and asked if they agree for their GP or Health Visitor to be notified of their distress. If

women cannot be contacted directly after three attempts, their GP or Health Visitor will be contacted and

informed of their distress.

Sample size

Table 1. Estimated frequency of the events which make up the primary outcomes

Outcome Average Source of information

Number of antenatal visits by nullips (consultant and midwife)

Average number of visits 10.9 (SD 6) Recorded Delivery22

Edinburgh Postnatal Depression Scale (EPDS)

Average score 5-7 (SD 6)

Psychosocial and psychological interventions for preventing postpartum depression (Cochrane review)23

Table 2. Estimated sample size calculations for number of antenatal visits Average number of antenatal visits

Average number in intervention arm Difference Power Sample size

per arm 8.9 10.9 2 90% 190

9.4 10.9 1.5 90% 337

Table 3. Estimated sample size calculations for EPDS

EPDS average score

Average score in intervention arm Difference Power

Sample size per arm (assuming 20% drop out at

8-12 weeks) 7 5.5 1.5 90% 421

A sample size of 421 per arm would provide 90% power (at the 5% significance level) to detect a

reduction of 1.5 in the average EPDS score (Table 3), and would provide greater than 90% power to

detect increased engagement with antenatal services of either 1.5 or 2 visits (Table 2).


Although the scientific basis for antenatal care does not appear to be as robust as it might, it is based on

the assumption that engagement with services results in improved maternal and perinatal health

outcomes. So, the number of visits (both consultant and midwife) attended should act as a surrogate for

improved maternal and neonatal outcomes. Antenatal care programmes, as currently practiced,

originate from models developed in 1929, although the significance of the frequency of appointments

and intervals between them have not, once again, been scientifically tested. Currently, NICE

recommend, in the Antenatal care Guideline,24

that the schedule of appointments should be determined

by the function of the appointments and for nulliparous women with an uncomplicated pregnancy, they

recommend that a schedule of ten visits should be adequate. The actual number of appointments

attended is based on a survey of women’s experiences of maternity care22 carried out in 2006. This was

a national survey which used a random sample of 4800 women and achieved a response rate of 63%.

Women were sent a postal questionnaire three months after birth. Nulliparous women reported they

attended a mean of 10.9 (SD 6) antenatal appointments.

There is limited evidence relating to number of antenatal visits and perinatal outcomes. An observational

study explored the relationship between the number of antenatal visits made by 17,765 British women

and adverse perinatal outcomes.25 No consistent relationship between admission to neonatal unit or

perinatal mortality and number of antenatal visits was found. A significant positive relationship was

found between number of antenatal visits and Caesarean section, and low birth weight (less than 2500g)

was positively associated with number of visits for nulliparous women but not for parous women. More

recently, a cohort study from Finland found under-attending free antenatal care was associated with

adverse pregnancy outcomes.26

Logistic regression analyses found there were significantly more low

birthweight infants in the under and non attenders, with more fetal and neonatal death.

It is well documented that a reduction in maternal depression, in addition to improving maternal

wellbeing, will have a beneficial effect on short and long term child outcomes and it is plausible that

social support provided by the POWs could reduce the numbers of women becoming depressed.

Studies have shown that depressed mothers are more likely to demonstrate impaired maternal-infant

interactions and negative perceptions of infant behaviour.8 Children of depressed mothers are more

likely to suffer a range of adverse outcomes, including insecure attachment, behavioural problems,

cognitive developmental deficits and difficulties in emotional functioning, some of these continuing into

adolescence.9,27,28,29,30

We explored powering the study using a composite primary outcome of perinatal morbidity and mortality

but the substantial sample size required to show even a large difference, together with funding

constraints for the POW service whilst under evaluation, have meant we have opted for the smaller

sample size required for the primary outcomes of engagement with services and EPDS at 8-12 weeks

after birth.


Pilot Phase

Following a successful six month pilot in which 475 women were recruited a revision to the sample size

was agreed. Prior to the pilot there was no data on the extent of the social risk factors amongst women

and data from the pilot showed that 36% of the women recruited had one social risk factor. It was agreed

to power the study for the pre-specified sub group comparison of two or more social risk factors, which

lead to an increase in the sample size to 1316 women. It is anticipated that this sample size will be

obtained by 31st December 2011.

Numbers of women eligible

Within the three hospital Trusts approximately 15,000 women a year give birth, of whom about a third will

be nulliparous (5000). The majority of nulliparous women book less than 25 weeks gestation (75% in

HOB PCT and 93% in SB PCT - data from WMPI) so the majority of women should book early enough to

be eligible for inclusion in the trial.15

There are currently no robust methods for collecting the numbers of women with social risk factors

throughout the three PCTs.

Minimisation of bias

The study is randomised but blinding will not be possible due to the nature of the intervention. Loss to

follow-up for the antenatal contacts and clinical data will be negligible as this information will be routinely

collected on mother and baby on discharge from hospital. Should either be transferred to another

neonatal unit, data will be collected from all the hospitals that provide care.

Loss of data regarding the psychological, longer term and additional data collected from the woman and

baby will be minimised by the development of robust systems to maximise response rates.

Loss to follow up

Loss to follow-up for the primary outcome of antenatal attendance, both at hospital and in the

community, will be negligible as this information is collected routinely by the hospitals. The primary

outcome of EPDS will be more challenging to obtain due to the nature of this group of women, therefore

we have allowed for a 20% drop out in our sample size calculation and will review this following the pilot.

Secondary outcomes:

• Loss of data relating to maternal and perinatal morbidity and mortality collected from routine data

sources from hospitals is likely to be minimal.

• Data on babies receiving care in neonatal unit will be obtained via the Badger data collection

system, which all the hospitals use. For the rare instances where babies are transferred out of

the recruiting hospital to another hospital for specialist care, data will be collected from all the

hospitals providing care for that child prior to discharge home or death.


• Loss of data from the PCTs Child Health Services routine data collection systems regarding child

health assessments, breastfeeding continuation rates and immunisation uptake is also likely to

be minimal as it will also be obtained from this source.

Permission will be obtained from each hospital/PCT for access to the data that is collected routinely,

which we intend to access.

Statistical analysis

We will calculate the mean number of visits and mean EPDS for each arm and compare differences

using the t-test or other appropriate non-parametric test. Variations will be explored by pre-specified

sub-group comparisons. Variations in patient characteristics between intervention and control groups

will also be explored, and if appropriate, variations in patient characteristics adjusted for using

generalised linear models with appropriate consideration of strata of randomisation.

For secondary continuous outcomes, variations between control and intervention groups will be

investigated using the t-test and, if necessary, covariate adjustment made using generalised linear

models, or generalised linear models (to include strata affects); for secondary binary outcomes,

differences will be compared using chi-squared tests and, if necessary, logistic regression. For all

analyses, assumptions of various tests will be explored and non-parametric tests used if required.

All analyses will be by intention to treat. Missing covariate and outcome data will be examined. Reasons

for withdrawal, lack of participation and any reasons for non-compliance will be documented and

explored. Complete case and available case analyses will be completed in the first instance. If the

amount of missing data is not insignificant, then multiple imputation will be used to evaluate sensitivity to

the missing completely at random assumption, and inferences compared to those under the lesser

missing at random assumption.

Pre-specified sub-group comparisons will be according to number of social risks (1 social risk or 2 or

more social risks) identified and gestation at recruitment (<12 weeks, 12-19+6 weeks, 20 - 27+6 weeks).

These pre-specified subgroup comparisons will be for the primary outcomes and the more clinically

important secondary outcomes (perinatal composite outcome, self-efficacy and Mother-to-infant

bonding). The level of significance will at 0.05 with 95% confidence intervals.

The remaining secondary outcomes will have the level of significance at 0.01 with 95% confidence

intervals. Having 95% confidence intervals for these outcomes will help to maintain the relevance to

clinicians and be comparable with existing findings.

Data monitoring Administrative monitoring will be used to monitor intended recruitment rates, compliance and violations

in entry criteria, and actions taken if deemed appropriate. It is not expected that the intervention will


generate any harmful effects or safety issues and so formal data monitoring of outcomes will not be

undertaken.

At the end of the pilot we had intended that the trial statistician establish the baseline rate of the primary

outcomes in the control arm to ensure the estimated sample size is based on a similar rate (see earlier),

but this was not possible due to the time delay between recruitment of participants and the primary

outcomes being collected. No analysis will be undertaken by treatment group. It was not possible to

check possible contamination in the control arm at the end of the pilot as this information was not

available.. Data collected during the pilot phase will be included in the analysis of the main trial.

Qualitative component to the ELSIPS study.

To complement the findings of the RCT, we intend to undertake additional qualitative research to

document and analyse the work of the POW. Process information is being collected by the POWs which

includes the frequency, venue, duration, support offered, additional social risk disclosure and referrals to

other agencies. To complement this we are planning to further explore the work undertaken by the

POWs with the woman by shadowing them undertaking their daily work. This will have two key benefits

for the trial.

• It will allow us to ensure that the components and process of the intervention itself (the

relationship and support offered by the POW) are fully understood, and help future policy makers

determine whether the intervention might need to be adapted to reflect their population and

health system.

• It may help to identify aspects of the intervention that are particularly successful and areas that

would benefit from future redesign or efficiency/quality improvement work.

Data Collection Methods

1. Document analysis – to identify the formal context, structures and processes by which the POWs work

is organised.

2. Shadowing (participant-observation with informal interviewing) 31 of the POWs conducting their daily

work, to identify the informal processes by which they interact with the women and any unanticipated

aspects and outcomes of their work. The researchers will not play an active part in the POWs activities -

they are purely there to observe. This work will be undertaken by Nicola Gale, an experienced qualitative


researcher employed on the CLAHRC programme, and Lucy Ingram, the research midwife employed to

support the trial.

Due to time and resource constraints we intend to limit the shadowing to a purposive sample of the

POWs by selecting a number of the 16 midwifery teams within which the POWs work. To increase the

transferability of the findings, the midwifery teams will be selected to represent a number of areas within

Birmingham and thus give insight into the work of the POW with women from a variety of ethnic

backgrounds and social risks and will give us the opportunity to shadow a number of POWs. It is

intended that the POWs work in both the ante and postnatal periods will be observed.

Consent to participate

The researchers will visit all the POWs team meetings to ensure they all have information about this

work and to answer any questions they may have. For those midwifery teams selected, the POWs will be

approached by their Managers and given an Information Leaflet and consent form about this additional

component of the study. If they do not wish to take part they will be given the opportunity to decline

without the researchers being present. Those who wish to take part will sign the consent form and return

it to their managers, who will liaise with the researchers. Once consent has been obtained, either Nicola

or Lucy will arrange to follow them for a period of time (probably about a week). Nicola and Lucy will

follow a POW through their ‘normal’ working day, including travelling to see clients, observing face-to-

face contacts, and observing any research or other activities the POW undertakes on behalf of the

woman she is supporting.

As the emphasis of this study is to further explore the work of the POW, we do not intend to seek written

consent from the women the POWs are supporting. The POW managers will inform all the women that

the POWs are currently supporting once we have selected the midwifery teams we wish to sample. This

will be done by sending a letter informing them the study is underway and that they might find that the

meeting they have with the POW is being observed. At the point the meeting is to take place the POW

will ask the women for verbal agreement to the researcher being present. If this is not given the meeting

will take place without the researcher being present. We have opted for this procedure as the focus is

not on the women, but on the work of the POW, and we are keen to minimise the impact of the observer

being present on the interaction between the POW and the woman.

Data Analysis

Both researchers will shadow the POWs in all aspects of their daily working lives, write field notes and

discuss their findings. The data will be analysed inductively using a grounded theory approach32 to build

a theoretical explanation about how the intervention works and how the work of the POW is structured by

the formal mechanisms in place and influenced by the social context. Potential sources of theoretical

congruence, from within the sociological and public health literatures, include ‘social capital’ 33,34,35 and


‘health literacy’ 36

. However, consideration will also be paid to issues of emotional experience, coping

with stressful and abusive social situations, material poverty and geographical access.

Ethics Declaration of Helsinki

The Chief Investigator (CI) will ensure that this study is conducted in full conformity with the current

revision of the Declaration of Helsinki (last amended October 2000, with additional footnotes added in

2002 and 2004).

Guidelines for Good Clinical Practice (GCP) The CI will ensure that this study is conducted in full conformity with relevant regulations and with the

Research Governance Framework.

Withdrawal criteria In accordance with the current revision of the Declaration of Helsinki and any other regulations, a woman

has the right to withdraw both herself and her baby from the study at any time and for any reason,

without prejudice to their future medical care by the health care professionals or at the institution, and is

not obliged to give any reason for this. Should this happen, the women will be informed that the data

already collected will be used for study purposes.

Independent Ethics Committee A copy of the protocol, proposed consent form, and written participant information and any proposed

advertising material will be submitted to an Independent Ethics Committee for written approval. The CI

will submit and, where necessary, obtain approval from the Independent Ethics Committee for all

subsequent protocol amendments and changes to the informed consent documents. The Investigator will

notify deviations from the protocol occurring at the sites to the local sponsor and will notify the

Independent Ethics Committee of these in accordance with local procedures.

Participant confidentiality The CI will ensure that all information about the mother and baby is kept confidential. The mother and

baby will be identified by name (consent will have been given by the mother) and unique study number

on the data collection forms. All documents will be stored securely and kept in strict confidence in

compliance with Data Protection Act (1998).

Assessment of safety


We are not anticipating harm could arise from the POW service and therefore are not proposing any

formal assessment of safety. We will, however, monitor the outcomes we collect and continually review

them as the trial progresses.

Quality control and quality assurance procedures Compliance with the protocol will be ensured by a number of procedures: Site set-up and training We intend to support the community midwife teams by providing between three and seven hours support

a week depending on the size of the community team and the numbers of births. There are 16 teams

within the three maternity units covering the three PCT’s. All ELSIPS midwives will attend training before

recruitment begins to ensure they are fully appraised of issues such as consent, study procedures and

data collection and follow-up. Appropriate GCP training will also be given. Training will be given every

six months to the ELSIPS midwives to ensure they remain enthused and updated with the trial. Target

numbers of women expected to be recruited will be agreed prior to commencement of the trial, and there

will be the possibility of contracts being terminated. Start-up visits with each team will take place before

the first woman is recruited to ensure all midwives are fully aware of ELSIPS procedures. Regular site

visits will be made to ensure adherence to the protocol and to deal with any site specific issues.

Data processing and monitoring All study data will be:

• monitored centrally for consistency, viability and quality at the Trial Office, • screened for out-of-range data, with cross-checks for conflicting data within and between data

collection forms using computerised logic checking systems, • referred back to the relevant centre for clarification in the event of missing items or uncertainty, • checked for accuracy and consistency based on a random 10% of records, • stored for 10 years.

Direct access to source data/documents Data collected for this trial does not involve access to source data, but uses transfer of routinely

collected data or completion of questionnaires by participants. The investigator(s)/institution(s) will

permit Study-related monitoring, audits, review by Ethics Committee, and regulatory inspection(s),

providing direct access to data obtained by the Trial Office to authorised study or regulatory personnel.

Monitoring data quality All data will be monitored using central statistical monitoring for quality assurance (consistency, viability

and quality) using bespoke data management systems. Central statistical monitoring is used to monitor

patterns of recruitment at sites, frequency of outcomes found, time of recruitment, etc.


The databases will be developed by the Primary Care Clinical Research and Trials Unit (PC-CRTU), who

will establish Study specific programs to extract certain fields from the database (as requested by the CI)

and to cross check information. These fields may include measures of eligibility criteria, duration of

treatment and compliance.

The CI, with Project Management Group (PMG), will review the results generated for logic and for any

patterns or problems and will decide if any action is required. Outlier data will be investigated.

Data handling and record keeping At randomisation a study patient identifier number and allocation will be made by the telephone

randomisation service operated by PC-CRTU. This data and all other trial data will be entered onto a

SQL Server database system built, hosted and maintained by the PC-CRTU. Data collected directly

from NHS organisations will be transferred electronically to the PC-CRTU via a secure encrypted link.

This system will include a database and data entry application built to standardised designs according to

University and PC-CRTU's security and quality policies and procedures. Data coding and automated

validation checks with message alerts for any problems are used to ensure data quality. Access to the

trials system is online via a secure encrypted link and is restricted to authorised users who have a

username and secret password. Functionality on the application is restricted based on the users role. A

full audit log of all changes to trial data is maintained automatically by the system. The application will

supply reports to help trial staff manage the administrative duties, for example, supplying recruitment

figures and lists of due and missing forms. Statisticians will use the data for analysis to produce the

results of the Trial.

PC-CRTU database servers are protected by physical and electronic access security measures. The

servers are kept in a locked rack, in a locked room in a corridor accessible only to a controlled group of

trials unit staff using swipe cards. Electronic access is protected by a hardware firewall on the trials unit

network, and a software firewall on the server. Server access is restricted to named individuals in

domain security groups, with user rights limited to what is needed for their role. Data is automatically

backed up each night to another similarly secured server in another part of the building, and then onto

tapes which are kept in a fire proof safe.

Funding Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for Birmingham & Black

Country is one of nine pilot CLAHRCs funded by the National Institute for Health Research (NIHR).

CLAHRCs have been established to undertake high-quality applied health research focused on the

needs of patients and to support the translation of research evidence into practice in the NHS. The aim


of these CLAHRCs is for researchers to work alongside service providers to evaluate new or existing

services.

The CLAHRC for Birmingham & Black Country covers all the Birmingham Primary Care Trusts and

extends into the area covered by two of the four Black Country PCTs. The research programme

involves nine discrete research or implementation themes that address health inequalities, service

redesign, access to targeted services and enhancement of quality and safety of services. The Evaluation

of Lay Support in Pregnant women with Social risk (ELSIPS) trial is one of the projects set up to evaluate

the effectiveness of the Pregnancy Outreach Worker service based in the Birmingham PCTs.

Project Management Christine MacArthur will be responsible for overall project management and supervision of the staff.

Together with the Project Management Group, she will ensure that targets are met, data collections tools

are developed, recruitment is successful, data are collected and managed effectively and that follow-up

is completed. This will also include visits to the collaborating Maternity Units and ‘trouble-shooting’ any

problems that arise.

The Project Management Group, which will comprise of Christine MacArthur (experienced chief

investigator of large maternity related trials), Sara Kenyon (experienced maternity researcher), Kate Jolly

(experience in public health and primary care), Karla Hemming (statistician), Lucy Ingram (research

midwife) and they will meet at least fortnightly to discuss progress.

The Theme Management Group (TMG) will meet every six months and outside this their expertise will

also be drawn upon as and when required.

University of Birmingham Richard Lilford Director of CLAHRC BBC Programme

Jackie Blissett Senior Lecturer in Psychology

Nicola Gale Senior Research Fellow in Medical Sociology

Caroline Fox Lecturer in Obstetrics and Gynaecology

Gateway Family Services Vicki Fitzgerald Chief Executive, Gateway Family Services

Joanne Harper Programme Lead, Gateway Family Services

PCTs Jacky Chambers Director of Public Health, HoBtPCT

Diane Reeves Lead for Birmingham Health and Wellbeing Partnership

Or their nominated representatives

Heads of Midwifery (Midwifery Leads) Jenny Henry Birmingham Women’s NHS Foundation Trust


Elaine Newell Sandwell & West Birmingham NHS Trust

Paula East Heart of England NHS Foundation Trust

Consumers Amy Mclean and Michelle Dalton, MSLC

Ishrat Nasim and Zainab Sesay, POW users

Independent oversight to the trial will be provided by the CLAHRC Steering Group which comprises of

Rashmi Shukla (Chair), Regional Director of Public Health/Medical Director NHS West Midlands &

Department of Health Government Office for the West Midlands; Diane Reeves, Medical Director

(Commissioning), South Birmingham PCT; David Adams, University of Birmingham; Robert Bacon, Chief

Executive, Sandwell PCT; Barry Clark, Chaplaincy Manager, UHBFT; Jo Foster, Academy Manager,

BCRA; Richard Lilford, Director CLAHRC & Director BCRA; Julian Miller, Head of Financial Management

and Planning, UHBFT; David Rosser, Medical Director, UHBFT; Michael Sheppard, Vice-Principal,

University of Birmingham.

Risk assessment The PMG assessed the study using a tool designed by Barts and the London which assess risk in terms

of scale of research, patient/study population, intervention, CI, monitoring arrangements,

information/personal data, the protocol, finance and consent. Overall, it was considered a minor risk.

Insurance and indemnity The trial is funded by the National Institute of Health Research (NIHR) through the CLAHRC programme.

The University of Birmingham (UoB) are the sole sponsors and will provide clinical trials insurance.

• The Protocol has been designed by the CI and researchers employed by the University and collaborators. The UoB has insurance in place (which includes no-fault compensation) for negligent harm caused by such Protocol design by the CI and researchers employed by the UoB. Sites, which are part of the United Kingdom's National Health Service, will have the benefit of NHS Indemnity.

The R&D Departments in the three collaborating Trusts’s (Birmingham Women’s NHS Foundation Trust,

Heart of England NHS Foundation Trust and Sandwell & West Birmingham NHS Trust) will administer

the appointment, job description and payment for a part-time (3 hours a week per team) local co-

ordinating ELSIPS midwife to lead the study in each of the midwifery teams for an initial period of 12

months, or until the close of recruitment, whichever comes sooner.

Publication policy The CI will co-ordinate dissemination of the data from the Study. Authorship at the head of the primary

results paper will be based on the uniform requirements adopted by medical journals which state that

authorship credit should be based only on substantial contribution to all of the conditions listed.


• Conception and design, or analysis and interpretation of data. • Drafting the article or revising it critically for important intellectual content. • Final approval of the version to be published.

All contributors will be listed at the end of the report, with their contribution to the trial identified with

acknowledgement including all local investigators, the Trial Office and staff.

Parents will be offered the opportunity of receiving a summary of the final results, which will be available

on the website and contain a reference to the full paper.


History of Amendments to Protocol

Amendment one- 14th April 2010 Protocol amendments These reflected changes to the Pregnancy Outreach Worker (POW) service as it had been extended until 6-8 weeks after birth and therefore the questionnaire needed to be sent at 8 weeks after birth, rather than 6 weeks as originally intended. Following discussions with the POW service providers one more item was added to the list of specified social risk factors which would identify the woman as being eligible for recruitment: ‘No support from either partner or family or friends’. We also excluded those under 16 years of age due to the complexity of recruiting this particular group. Following discussions with a Neonatologist we added Retinopathy of Prematurity to the secondary outcomes collected, if applicable. At recruitment women give us a friend/relative as an additional contact. We added that we will contact this person to check the woman’s contact details if the questionnaire sent at 8 weeks after birth is not returned. Participants Information Leaflets and letters were amended to reflect these changes.

Amendment two- 20th May 2010 Protocol amendments On the advice of Gateway Family Services we included underweight pregnant women (BMI less than or equal to 18) to the list of risk factors. We clarified that the randomisation sequence will stratify for each Maternity Trust, with random block allocation, since it is plausible that recruitment and culture could be different between the Trusts. We had approved a Summary Participant Information leaflet. Amendment three- 16th November 2010 Protocol amendments To complement the findings of the RCT, an additional qualitative component to document and analyse the work of the Pregnancy Outreach Workers (POWs) was approved. New letters for participants GPs and for those who request telephone completion of the questionnaire were approved. Amendment four-14th April 2011 Protocol amendments An increase in the sample size to 1316 was approved and will allow us to be powered for the pre-specified sub group comparison of women with two or more social risk factors. We added the option of the ELSIPS midwife making the final contact with women for follow-up if they are more appropriate than the lead healthcare professional at that time. For clarification purposes we added this section to describe the amendments in brief. Amendments to the letters for women who request telephone completion of the questionnaire were approved. Amendment five – 11th October 2011 Protocol amendment

If women declaring thoughts of harming themselves in question 10 of the Edinburgh Postnatal Depression Scale cannot be contacted directly after three attempts, their GP or Health Visitor will be informed of their distress.


Figure 1: Flow diagram to summarise allocation and contact throughout the trial

All nulliparous women less than 28 weeks have the systematic social risk

assessment by their MW

No social risks identified Social risk identified

Consent obtained by ELSIPS midwife Randomisation

Details passed on to ELSIPS MW in the team

POW No POW

Collection of routine data at hospital discharge

Follow-up at 8-12 weeks by questionnaire

ELSIPS introduced by MW completing social risk

assessment

Do not agree to take part


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Evaluation of Lay Support In Pregnant women with Social ... · differences in age, socioeconomic or smoking status, body mass index or parity. This study further highlighted the importance