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Objectives: To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally.Design: Open-label randomised controlled trial, with blinded outcome assessment.Setting: Community midwifery services in two National Health Service (NHS) trusts in the North West.Sample: A cohort of 2419 women receiving normal NHS postnatal care.Methods: Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses.Main Outcome Measure: The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview.Results: Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic 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) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). 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.Tweetable Abstract: Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth. [ABSTRACT FROM AUTHOR]

Objective: To evaluate, among medical students learning the female pelvic examination, the added benefits of training by gynaecological teaching associates compared with training involving a manikin only.Design: Randomised controlled trial.Setting: Nine university teaching hospitals.Population: Ninety-four medical students recruited prior to commencing a 4-week obstetrics and gynaecology rotation.Methods: The control training consisted of lectures, demonstration of the pelvic examination on a manikin, and opportunities to practise on this low-fidelity simulation (n = 40). The experimental group received additional gynaecological teaching associate training, delivered by pairs of experienced associates to groups of four medical students (n = 54).Main Outcome Measures: Outcomes measured at the end of the rotation included knowledge of the correct order of examination components (Yes/No), and student comfort [Likert scales anchored between 1 (very uncomfortable) and 4 (very comfortable) on four items] and confidence [Likert scales anchored between 1 (No) and 3 (Yes) on six items]. The primary outcome, measured at the end of the academic year, was the objective structured clinical examination of a female pelvis (score range 0-54).Results: At baseline, the groups were similar in age, gender, and ethnicity. At the end of the clinical rotation, when compared with the control intervention, the experimental intervention had a moderate effect on student knowledge [difference 29.9% (95% CI 11.2-48.6%); P = 0.002] and confidence [difference 1 (95% CI 0-2); P < 0.001], and a large effect on student comfort [difference 1.8 (95% CI 0.6-3.0); P = 0.004]. At the end of the academic year, the experimental intervention had no impact on skills compared with the control [difference 2 (95% CI-1 to 4); P = 0.26].Conclusions: Among medical students taught the female pelvic examination by low-fidelity simulation, additional training by gynaecology teaching associates improved knowledge, comfort, and confidence at the end of the clinical rotation but did not improve examination skills at end of the academic year. [ABSTRACT FROM AUTHOR]