Table of Contents - NIHR Clahrc Wessex · Web viewPre-eclampsia affects around one in ten pregnant women and contributes to serious adverse health outcomes for both mother and baby,

Social networks in high-risk pregnancy

Date and Version No: Version 1.0 24/01/18

Internal reference/ short title: Social networks in high-risk pregnancy

Ethics Ref:

Chief investigators: Dr Rebecca Band (University of Southampton) & Dr Lisa Hinton (University of Oxford)

[email protected] ; [email protected]

Co-investigators: Prof Anne Rogers, Dr Ivo Vassilev, Chris Allen (CLAHRC Wessex, University of Southampton)

Dr Katherine Tucker, Prof Richard McManus (CLAHRC Oxford, University of Oxford)

Sponsor: University of Oxford,

Clinical Trials and Research Governance, University of Oxford

Joint Research Office, Block 60, Churchill Hospital

Oxford, OX3 7LE

[email protected]

Funder: NIHR CLAHRC Wessex & NIHR CLAHRC Oxford

Social networks in higher-risk pregnancy Page 1 of 10Version 1.0 24/01/18

mailto:[email protected]



Table of Contents

Contents

Table of Contents..................................................................................................................................2

1. Study background..........................................................................................................................3

Rationale for the study......................................................................................................................4

How will the results of this study be used?.......................................................................................4

3. Methods:........................................................................................................................................5

Design................................................................................................................................................5

Participants........................................................................................................................................5

Procedure..........................................................................................................................................6

Assessments:.....................................................................................................................................6

4. Analysis:.........................................................................................................................................7

5. Data management..........................................................................................................................8

6. Project timetable............................................................................................................................8

Outline of project timelines and activities:........................................................................................8

Project outputs:.................................................................................................................................8

7. Ethical considerations....................................................................................................................9

Approvals...........................................................................................................................................9

An amendment will be made to the main RCT ethical approvals (reference 17/WM/0241).............9

8. References.....................................................................................................................................9


1. Study background

Pre-eclampsia affects around one in ten pregnant women and contributes to serious adverse health

outcomes for both mother and baby, with about 15% of maternal mortality attributed to pre-

eclampsia [1]. Despite the incidence of raised BP in pregnancy, women do not necessarily perceive

themselves as higher-risk as the causes and associated implications can be difficult to comprehend

[2], which can result in difficulties understanding the relevance of health information [3]. Additional

monitoring of health status during pregnancy (such as self-monitoring of blood pressure (BP)) may

be beneficial for alerting women to the early warning signs associated with risk status [4, 5].

However, many describe the experience of pre-eclampsia as “a paradox”, which can be hard to

meaningfully understand in the absence of symptoms [6]. This can be compounded by difficulties in

asking questions to medical professionals; women report feeling too anxious or fearful to do so, that

information provided can be inconsistent and a lack of understanding of medical terminology [6].

In addition, negative psychosocial consequences accompany the experience of pre-eclampsia: this

may include feelings of guilt, disappointment, loss of control, stigma for at-risk status and fear of

harm (or death) for themselves and their baby [7-9]. Social support from several key sources, such as

the partner, family, and other women who have also been through similar experiences has been

identified as important for recovery and psychological wellbeing [2, 6, 10]. A recent study also

suggested that following pre-eclampsia, lack of social support and feelings of isolation were a major

barrier in women implementing and sustaining the lifestyle changes necessary to manage health

[11].

This aligns with a small body of evidence which suggests that social support is important more

generally in pregnancy for maternal health outcomes such as pre-term birth, negative birth

experiences and adverse outcomes [12-14]. Support may also provide a buffer against adverse

mental health outcomes, such as anxiety and depression [12, 15-17]. The context of social support is

important, and different within the partner relationship, family and network more widely [15]. A

social network perspective may therefore be beneficial in coherently combining these different

aspects. Additional attempts have been made to differentiate the various types of support that

women may seek in pregnancy, such as emotional (i.e. reassurance, social isolation, shared

experiences); informational (problem solving and evaluation of self-perceived competencies) and

practical (such as household chores or other daily hassles) [15, 18]. Emerging evidence has also

suggested that marginalised or isolated mothers may use the internet and social networking sites as

a means to improve perceived support [19, 20].

Rationale for the study


This project proposes a cross-CLAHRC collaboration and builds on expertise and ongoing work in self-

monitoring of blood pressure in pregnancy (RM, LH, RB, KT), use of online information and support

in pregnancy (LH, RM) and network mapping (RB, AR, IV, CA).

The current study will be nestled within the BUMP (Blood pressure monitoring in high risk pregnancy

to improve the detection of monitoring of hypertension) Randomised Controlled Trial (RCT). Women

will be invited to take part in the BUMP RCT if they are considered to be higher-risk for pre-

eclampsia, as outlined with the current NICE guidelines. Participants included within the BUMP study

will be asked to self-monitor their blood pressure from 20 weeks gestation until after birth to

facilitate early detection of rising blood pressure (and therefore reduce risk of pre-eclampsia

occurrence). Qualitative exploration of women’s’ experiences in the pilot study highlighted that

adherence to blood-pressure self-monitoring dropped at the time when risk for pre-eclampsia was

increasing: this also coincided with disruption to regular lifestyle routines [21]. The current study will

therefore attempt to explore how these factors potentially interact.

2. Study aims

The overall aim of the current study is therefore to explore social support available to women who

are at higher risk of pre-eclampsia during pregnancy by examining personal social networks. This

work aims to extend current knowledge by:

1. Mapping personal social networks in pregnancy.

2. Exploring changes in personal social networks across pregnancy (i.e. changes in the level and

type of support, or network classification).

3. Exploring how online and offline networks interact with the health experience and care

pathways in pregnancy.

4. Exploring whether participation within the BUMP RCT (i.e. implementing a BP self-monitoring

intervention in daily life) impacts on women’s social networks and pregnancy experience.

How will the results of this study be used?

The results of the study will provide preliminary information about the changes in networks across

pregnancy. In addition, it may highlight that these changes are potentially co-occurring with

important clinical time-points (increased risk for pre-eclampsia) and behavioural outcomes (non-

adherence to self-monitoring) which may inform future antenatal interventions. It will also allow us

to explore how participation in an RCT during pregnancy interacts with the healthcare experience.

3. Methods:


Design

Mixed-methods will be used: network mapping will be undertaken with participating women,

accompanied by in-depth interviews to explore the sources of support within the personal network

(including access to support, how this is negotiated, or any recent changes in support) and how this

is integrated with their healthcare experience in pregnancy and participation in the trial. A brief set

of questionnaire measures will be collected alongside each network mapping.

Participants

The BUMP RCT criteria are as follows:

Participant is willing and able to give informed consent for participation in the trial

Pregnant woman, aged 18 years or above between 16+0 to 24+0 weeks

Able and willing to comply with trial requirements

Willing to allow her GP and consultant, if appropriate, to be notified of participation in the trial

At higher risk for hypertension in pregnancy / pre-eclampsia defined as one or more of the

following risk factors:

Age 40 years or older

Nulliparity

Pregnancy interval of more than 10 years

Family history of pre-eclampsia

Previous history of pre-eclampsia or gestational hypertension

Body mass index 30 kg/m2 or above at booking

Chronic kidney disease

Twin pregnancy

Diabetes (Type 1&2)

Autoimmune Disease (e.g. systemic lupus erythematosis or antiphospholipid disease)

We will purposively recruit 25-30 women from the BUMP RCT to participate in this study to ensure

diversity in age, socio-economic and ethnic background and health literacy (this may include women

in the control condition). Initially we will focus on women who are in their first pregnancy

(Nulliparity).

Procedure

Eligible women will be invited to take part in the study following entry in to the BUMP study from 20

weeks gestation. Women who have consented to contact at main trial enrolment will be contacted


by phone/email/in person regarding the interviews and provided with the PIS at this time. Separate

written informed consent will be obtained for the current study.

Assessments:

There will be up to three assessments per participant: these will occur at the approximate times

outlined below:

Upon entry into the current study (approx. 20 – 25 weeks gestation)

At approx. 36 weeks gestation (+/-3 weeks): due to increased lifestyle disruption [21], co-

occurring with increased risk for pre-eclampsia during this period.

Postnatally (at approx. 12 weeks after birth): as blood pressure may remain high after birth, and

there are likely to be substantial network changes in the immediate postnatal period.

Each assessment will comprise of:

1. Network mapping:

Generating Engagement in Network Involvement (GENIE) is a facilitated web-based social

networking tool (www.genie.soton.ac.uk). Using the concentric circles method (22), participants are

guided through the process of thinking of (and consequently mapping) the relationships relevant to

health and wellness (which may include family members, friends, acquaintances, healthcare

professionals, local groups and online information/ support) (22-24). Previous work has highlighted

that this process realigns thinking (i.e. conceptualisation of self as the centre of the network),

enables participants to explore family dynamics and recognise the role of others in the network

(22).The GENIE mapping tool will be used to create a visual image of a participant’s personal support

network, with each of the 3 circles representing degrees of importance in terms of support. For each

network member additional information will be collected about the type of relationship, frequency

of contact and may look at connections between network members (to examine network density).

The mapping exercise will be done online

2. Questionnaires:

At each assessment women will be asked to complete a brief set of questionnaire measures. These

will comprise:

• Collective efficacy (CENS) – 20 items measuring network responsiveness, access to collective

efficacy, and health-specific collective efficacy.

• Loneliness (De Jong Scale) – 6 items measuring social loneliness and emotional loneliness.


• Relationship quality (revised dyadic adjustment scale) – 14 items measuring couple

consensus, satisfaction and cohesion.

Behavioural data will also be collected within the main RCT and includes self-efficacy and anxiety

(which will be collected at 30 weeks gestation and up to 12 weeks postnatally).

3. Qualitative interviews with participating women:

These semi-structured interviews will focus on the types of support that are important to women

during their pregnancy, and how support networks are integrated, particularly in the context of

blood pressure self-monitoring and the healthcare experience in pregnancy. We will also explore the

way in which participation in the intervention (implementing self-monitoring into pregnancy)

interacts with the personal social network, particularly in relation to the role of healthcare

professionals.

4. Analysis:

The network mapping data will be used to distinguish between types of networks and network

properties associated with self-management support [22, 23].We will analyse the extent and nature

of contacts within the social network, how new sources of information or support are identified and

integrated into the network, including how new connections improve capacity to enact health

behaviours, improve wellbeing or reduce isolation. Comparisons will be made across time points, to

explore changes in circumstances (such as use of health care services) [24].

All interviews will be audio-recorded and transcribed. A thematic analysis of interview data will be

conducted to ensure an inductive approach. Repeated readings of transcripts and listening of

recordings will assist familiarisation with the data and identification of initial codes, these will then

be defined and guide analysis of the full data set. Using constant comparison, a technique derived

from grounded theory transcripts will be compared within and between each other aiding the

iterative search for themes, which will then be reviewed, defined and named.

Quantitative data will be used to undertake exploratory statistical analysis to examine relationships

between network composition and collective efficacy, relationship adjustment and loneliness. These

association will be assessed using bivariate correlations, with linear regression modelling to predict

outcomes (if appropriate).

5. Data management


All documents will be stored safely in locked cupboard in locked rooms with restricted access. On all

trial-specific documents, other than the signed consent, the participant will be referred to by the

trial participant number/code, not by name.

6. Project timetable

Outline of project timelines and activities:

Project outputs:

1. Articles focused on:

Social networks in pregnancy, change

over time and potential association with

questionnaire measures

Social networks and the healthcare

experience in pregnancy – focussing on

integration of online networks, self-

monitoring and interventions in to care

pathways.

2. Potential to develop the role of networks

and social support further in pregnancy,

and more widely in the context of other RCTs

3. Facilitating cross-CLAHRC collaboration

7. Ethical considerations

Approvals

An amendment will be made to the main RCT ethical approvals (reference 17/WM/0241).

8. Costs

The total projected non-staff costs are therefore estimated at approx. £13k and overall costs will

include staff costs (estimated at approx. £40K) plus overheads (not estimated). The overall cost of

the project will be shared equally between each CLAHRC, so £26,500 each.

Estimated costs are as follows:


1 RA post doc qualitative researcher for 0.8 FTE* from 01/03/18 to 31/08/19 (*based on Grade 4 point 30 Southampton payscale - £32,548 p/annum 1FTE)18 months at 0.8 = ~ £39057 (not including estimates for overheads/ faculty costs)

~£40k

Equipment (recorder and laptop) ~ £850Consumables (invites, postage, printing, transcription for 90 interviews) ~ £5000PPI input ~£300 Payment (at £10 voucher per interview) ~£900Open-access publication @1500 x2 £3000

9. References

1. L., D., The global impact of pre-eclampsia and eclampsia. Semin Perinatol, 2009. 33(3): p. 130-7.

2. Fleury, C., M. Parpinelly, and M.Y. Makuch, Development of the mother–child relationship following pre eclampsia.‐ Journal of Reproductive and Infant Psychology, 2010. 28(3): p. 297-306.

3. Brown, M.C., et al., Women’s Perception of Future Risk Following Pregnancies Complicated by Preeclampsia. Hypertension in Pregnancy, 2013. 32(1): p. 60-73.

4. Harris, J., et al., The psychological impact of providing women with risk information for pre-eclampsia: A qualitative study. Midwifery, 2014. 30(12): p. 1187-95.

5. Hodgkinson, J.A., et al., Is self monitoring of blood pressure in pregnancy safe and effective? . BMJ, 2014. 349: p. 6616.

6. Barlow, J.H., J. Hainsworth, and S. Thornton, Women's experiences of hospitalisation with hypertension during pregnancy: feeling a fraud. Journal of Reproductive and Infant Psychology, 2008. 26(3): p. 157-167.

7. Poel, Y.H.M., P. Swinkels, and J.I.P. de Vries, Psychological treatment of women with psychological complaints after pre-eclampsia. Journal of Psychosomatic Obstetrics & Gynecology, 2009. 30(1): p. 65-72.

8. Pampus, M.G.v., et al., Posttraumatic stress disorder following preeclampsia and HELLP syndrome. Journal of Psychosomatic Obstetrics & Gynecology, 2004. 25(3-4): p. 183-187.

9. de Souza, N.L., A.C. Araujo, and C. Costa Ido, [The meanings that postpartum women assign to gestational hypertension and premature birth]. Rev Esc Enferm USP, 2011. 45(6): p. 1285-92.

10. Roberts, L.M., G.K. Davis, and C.S.E. Homer, Pregnancy with gestational hypertension or preeclampsia: A qualitative exploration of women's experiences. Midwifery, 2017. 46: p. 17-23.

11. Skurnik, G., et al., Improving the postpartum care of women with a recent history of preeclampsia: a focus group study. Hypertension in Pregnancy, 2016. 35(3): p. 371-381.

12. Moshki, M. and K. Cheravi, Relationships among depression during pregnancy, social support and health locus of control among Iranian pregnant women. International Journal of Social Psychiatry, 2015. 62(2): p. 148-155.

13. Sigurdardottir, V.L., et al., The predictive role of support in the birth experience: A longitudinal cohort study. Women and Birth, 2017.

14. Agampodi, T.C., et al., Social capital and health during pregnancy; an in-depth exploration from rural Sri Lanka. Reproductive Health, 2017. 14(1): p. 89.

15. Coburn, S.S., et al., Multiple domains of stress predict postpartum depressive symptoms in low-income Mexican American women: the moderating effect of social support. Archives of Women's Mental Health, 2016. 19(6): p. 1009-1018.


16. Razurel, C., et al., Relationship between perceived perinatal stress and depressive symptoms, anxiety, and parental self-efficacy in primiparous mothers and the role of social support. Women & Health, 2017. 57(2): p. 154-172.

17. Jonsdottir, S.S., et al., Partner relationship, social support and perinatal distress among pregnant Icelandic women. Women and Birth, 2017. 30(1): p. e46-e55.

18. Bäckström, C., et al., ‘It makes you feel like you are not alone’: Expectant first-time mothers’ experiences of social support within the social network, when preparing for childbirth and parenting. Sexual & Reproductive Healthcare, 2017. 12: p. 51-57.

19. Nolan, S., et al., Social networking site (SNS) use by adolescent mothers: Can social support and social capital be enhanced by online social networks? – A structured review of the literature. Midwifery, 2017. 48: p. 24-31.

20. Mills, A., et al., Someone to talk to: young mothers’ experiences of participating in a young parents support programme. Scandinavian Journal of Caring Sciences, 2013. 27(3): p. 551-559.

21. Hinton, L., et al., Blood Pressure Self-Monitoring in Pregnancy (BuMP) feasibility study; a qualitative analysis of women's experiences of self-monitoring. BMC Pregnancy and Childbirth, In submission

22. Kennedy, A., et al., Dynamics and nature of support in the personal networks of people with type 2 diabetes living in Europe: qualitative analysis of network properties. Health Expectations, 2015. 18(6): p. 3172-3185.

23. Vassilev, I., et al., Social network type and long-term condition management support: A cross-sectional study in six European countries. PloS one, 2016. 11(8): p. e0161027.

24. Reeves, D., et al., The Contribution of Social Networks to the Health and Self-Management of Patients with Long-Term Conditions: A Longitudinal Study. PLOS ONE, 2014. 9(6): p. e98340.


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Table of Contents - NIHR Clahrc Wessex · Web viewPre-eclampsia affects around one in ten pregnant women and contributes to serious adverse health outcomes for both mother and baby,