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

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.