TY - JOUR

T1 - STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth

AU - Slade , Pauline

AU - West , Helen

AU - Thompson , Gill

AU - Lane, Steven

AU - Spiby , Helen

AU - Edwards, Rhiannon Tudor

AU - Charles, Joanna

AU - Garrett , Charlotte

AU - Flanagan , Beverley

AU - Treadwell , Maureen

AU - Hayden , Emma

AU - Weeks , Andrew

N1 - National Institute for Health Research. Grant Number: PB‐PG 021536037

PY - 2020/6

Y1 - 2020/6

N2 - Background: Post-traumatic stress disorder (PTSD) can develop after a traumatic childbirth.Objective: To test if providing psychological self-help materials would significantly lower the incidence of PTSD at 6-12 weeks postnatally.Design: Open label, randomised controlled trial, blinded outcome assessment.Setting: Community midwifery services in two North West NHS Trusts.Sample: 2419 women receiving usual NHS postnatal care.Methods: Midwives screened women for traumatic birth experience. 678 women who screened positive (28.1%) were randomly allocated to self-help with usual care (n=336) or usual care alone (n=342). Self-help materials, were a leaflet and on-line film designed to prevent the development of PTSD after trauma exposure through how to manage early psychological responses.Main outcome measure: The primary outcome was a composite of diagnostic and sub-diagnostic PTSD at 6-12 weeks postnatally using the gold standard Clinician Administered PTSD Interview (CAPS-5).Results: 478 of 678 (70.5%) correctly randomised women and 9 randomised in error were followed up. Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53). Findings remained consistent in the per protocol analysis (RR 1.04, 95% CI 0.85 to 1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost.Conclusions: Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced.

AB - Background: Post-traumatic stress disorder (PTSD) can develop after a traumatic childbirth.Objective: To test if providing psychological self-help materials would significantly lower the incidence of PTSD at 6-12 weeks postnatally.Design: Open label, randomised controlled trial, blinded outcome assessment.Setting: Community midwifery services in two North West NHS Trusts.Sample: 2419 women receiving usual NHS postnatal care.Methods: Midwives screened women for traumatic birth experience. 678 women who screened positive (28.1%) were randomly allocated to self-help with usual care (n=336) or usual care alone (n=342). Self-help materials, were a leaflet and on-line film designed to prevent the development of PTSD after trauma exposure through how to manage early psychological responses.Main outcome measure: The primary outcome was a composite of diagnostic and sub-diagnostic PTSD at 6-12 weeks postnatally using the gold standard Clinician Administered PTSD Interview (CAPS-5).Results: 478 of 678 (70.5%) correctly randomised women and 9 randomised in error were followed up. Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53). Findings remained consistent in the per protocol analysis (RR 1.04, 95% CI 0.85 to 1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost.Conclusions: Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced.

KW - Childbirth

KW - Post-traumatic stress disorder

KW - postnatal

KW - prevention

KW - randomised controlled trial

U2 - 10.1111/1471-0528.16163

DO - 10.1111/1471-0528.16163

M3 - Article

VL - 127

SP - 886

EP - 896

JO - BJOG: an international journal of obstetrics and gynaecology

JF - BJOG: an international journal of obstetrics and gynaecology

IS - 7

ER -