Data Sheet 1_Glucocorticoids after birth trauma and the associated risk of developing posttraumatic stress disorder: a non-randomized open-label pilot trial.docx

BackgroundPostpartum posttraumatic stress disorder (PTSD) occurs commonly in individuals after childbirth and is associated with adverse maternal and neonatal outcomes. The primary objective of this pilot study was to determine the acceptability and feasibility of administering glucocorticoids to reduce posttraumatic stress symptoms after a traumatic birth event.
MethodsThis was a single-center, non-randomized, open-label pilot trial conducted at Michigan Medicine. Postpartum patients who screened positive for PTSD DSM-V Criterion A (felt a threat to life or injury to self or neonate) were enrolled. Participants self-selected to either (1) receive hydrocortisone within 12 h of the traumatic event or (2) defer hydrocortisone and remain in an observational control arm. Participants were assessed at the time of enrollment and multiple time points postpartum (days 3, 14, and 42) for posttraumatic stress symptoms using the City Birth Trauma Scale. The analysis compared the distribution of PTSD symptom scores in the intervention and control arms over time via weighted generalized estimating equations.
ResultsStudy recruitment was highly successful, with 133 of 138 eligible patients (96%) enrolled, and only 9 of 261 approached patients (3%) refused to be screened for study participation. Among participants who chose to receive hydrocortisone, the study drug was administered within 12 h of birth in all cases (20/20, 100%). For the primary clinical outcome, PTSD score, 127 participants were included in the longitudinal analysis; n = 19 self-selected to receive the hydrocortisone intervention, and n = 108 enrolled in the control arm. In the hydrocortisone arm, PTSD scores significantly increased from baseline to postpartum day 14 [6.29, 95% CI (0.36, 12.22), p = 0.038] and from baseline to postpartum day 42 [7.46, 95% CI (0.30, 14.61) p = 0.041] when compared with the control's change in PTSD scores from baseline to postpartum day 14 and from baseline to postpartum day 42.
ConclusionsThese pilot findings demonstrate the acceptability and feasibility of enrolling obstetric patients into a pharmacologic clinical trial immediately postpartum. In those at high risk for PTSD, glucocorticoids did not decrease, and may have increased, PTSD symptomatology. Future larger and randomized trials are needed to confirm or refute these initial findings.
Clinical Trial Registration: https://clinicaltrials.gov/study/NCT04852458, identifier, NCT04852458.