title: Lay support for pregnant women with social risk: a randomised controlled trial.
abstract: OBJECTIVE
  We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.
  
  
  METHODS
  Prospective, pragmatic, individually randomised controlled trial.
  
  
  METHODS
  3 Maternity Trusts in West Midlands, UK.
  
  
  METHODS
  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. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.
  
  
  METHODS
  POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.
  
  
  METHODS
  Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 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 6 weeks, breastfeeding at 6 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 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -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 subgroup of women with 2 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.
  
  
  BACKGROUND
  ISRCTN35027323; Results.
authors.affiliation: Institute of Applied Health Research, College of Medical and Dental Sciences University of Birmingham, Birmingham, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Kenyon
authors.affiliation: Institute of Applied Health Research, College of Medical and Dental Sciences University of Birmingham, Birmingham, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Jolly
authors.affiliation: Institute of Applied Health Research, College of Medical and Dental Sciences University of Birmingham, Birmingham, UK.
authors.forename: Karla
authors.initials: K
authors.lastname: Hemming
authors.affiliation: University of Worcester.
authors.forename: Lucy
authors.initials: L
authors.lastname: Hope
authors.affiliation: School of Psychology, University of Birmingham, Birmingham, UK.
authors.forename: Jackie
authors.initials: J
authors.lastname: Blissett
authors.affiliation: Institute of Applied Health Research, College of Medical and Dental Sciences University of Birmingham, Birmingham, UK.
authors.forename: Sophie-Anna
authors.initials: SA
authors.lastname: Dann
authors.affiliation: Department of Population Evidence & Technologies, University of Warwick, Warwick Medical School, Coventry, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Lilford
authors.affiliation: Institute of Applied Health Research, College of Medical and Dental Sciences University of Birmingham, Birmingham, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: MacArthur
mesh_terms: D000293:Adolescent; D000328:Adult; D001942:Breast Feeding; D019052:Depression, Postpartum / Q000517:prevention & control*; D005260:Female; D006792:House Calls; D006801:Humans; D008880:Midwifery / Q000592:standards*; D010298:Parity; D011181:Postnatal Care / Q000592:standards*; D011247:Pregnancy; D037841:Pregnant People / Q000523:psychology*; D011295:Prenatal Care / Q000592:standards*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012307:Risk Factors; D020377:Self Efficacy; D012944:Social Support; D006113:United Kingdom; D055815:Young Adult
keywords: OBSTETRICS; PUBLIC HEALTH; pregnancy; social/lay support