OBJECTIVES We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. DESIGN Prospective, pragmatic individually randomised controlled trial. SETTING Three Maternity Trusts in West Midlands, UK. PARTICIPANTS Following routine midwife systematic assessment of social risk factors 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care or addition of referral to a Pregnancy Outreach Worker (POW) service. Under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. INTERVENTIONS Pregnancy Outreach Workers were trained to provide individual support and case management for the women including home visiting from randomisation to six weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. MAIN OUTCOME MEASURES Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Pre–specified, powered subgroup comparison was among women with two or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy and mother-to-infant bonding at 8-12 weeks; child development assessment at six weeks, breastfeeding at six weeks and immunisation uptake at 4 months, all collected from routine child health systems. RESULTS Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10·1 versus 10·1 (MD) –0·00, 95% CI, (95% CI, –0·37, 0·37)). In the powered sub-group of women with two or more social risk factors, mean EPDS (MD –0·79 (95% CI, –1·56, –0·02) was significantly better, although for all women recruited no significant differences were seen (mean difference (MD) –0·59 (95% CI, –1·24, 0·06)). Mother-to-infant bonding was significantly better in the intervention group for all women (MD-0.30 (95% CI, -0.61, -0.00) p=0.05) and there were no differences in other secondary outcomes. CONCLUSIONS This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered sub-group of women with two or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.
Bibliographical noteThe full text is also available from: http://dx.doi.org/10.1136/bmjopen-2015-009203
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