Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS): a randomised controlled trial

Abstract

BackgroundMaternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK).Method/DesignThe aim of this study is to evaluate a lay Pregnancy Outreach Worker (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. The study design is a randomised controlled trial (RCT) in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service.The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care) from randomisation (before 28 weeks gestation) until 6 weeks after birth.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 by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy) and mother-to-infant bonding will also be collected using validated tools.A sample size of 1316 will provide 90% power (at the 5% significance level) to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will be by intention to treat.Qualitative research will explore the POWs' daily work in context. This will complement the findings of the RCT through a triangulation of quantitative and qualitative data on the process of the intervention, and identify other contextual factors that affect the implementation of the intervention.DiscussionThe trial will provide high quality evidence as to whether or not lay support (POW) offered to women identified with social risk factors improves engagement with maternity services and reduces numbers of women with depression.MREC number10/H1207/23Trial registration numberISRCTN: ISRCTN35027323

Health system and community level interventions for improving antenatal care coverage and health outcomes

“…One trial with multiple arms aimed to evaluate health system and community interventions separately and together (Morris 2004a ). Ten trials evaluated community interventions alone (Barber 2008 ; Fottrell 2013 ; Laken 1995 ; Lewycka 2013a ; Manandhar 2004 ; Melnikow 1997 ; More 2012 ; Mori 2015 ; Mullany 2007 ; Tripathy 2010 ). The rest of the trials (13) aimed to evaluate a combination of health system and community interventions (Azad 2010 ; Baqui 2008 ; Bhutta 2011 ; Kirkwood 2013 ; Klerman 2001 ; Kumar 2008 ; le Roux 2013 ; Midhet 2010 ; Omer 2008 ; Villar 1992 ; Wahlstrom 2011 ; Waiswa 2015 ; Wu 2011 ).…”

Social support and maternal mental health at 4 months and 1 year postpartum: analysis from the All Our Families cohort

“…Previous studies show that group prenatal care and group prenatal education can provide multiple types of support 37 38. A randomised control trial of pregnancy outreach workers in the UK designed to provide tangible, emotional and informational support to vulnerable women showed a reduction in depressive symptoms 39. For areas where in-person support is not feasible, randomised clinical trials have shown that peer support interventions delivered over the phone or internet during the postnatal period can provide emotional and informational support and reduce depressive symptoms 36.…”

Lay support for pregnant women with social risk: a randomised controlled trial

“…21 Prior to the trial, data was not available on numbers of social risk factors women had. Following a successful initial 6 months pilot where 475 women were recruited, it was observed that 64% had two or more social risk factors, and it was agreed to increase the sample size to allow power to detect differences in primary outcomes in the prespecified subgroup of women with two or more social risk factors, that is, so that the required sample size of 421 would be recruited within this subgroup.…”