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

Abstract

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.