This prospective, randomised, controlled trial (n=1248) aims to explore the preventive effect of esketamine on postpartum depression in women undergoing cesarean section.
Esketamine, known for its rapid efficacy in treating refractory depression, is under investigation for its potential to prevent postpartum depression (PPD). The study seeks to evaluate whether prophylactic administration of esketamine can reduce the incidence of PPD in women undergoing cesarean section. The drug’s safety profile will also be assessed during the trial.
Participants, aged 18-40, will undergo elective cesarean section and must be primiparous with singleton pregnancies. Exclusion criteria include severe medical conditions such as hypertension and severe heart disease, as well as mental disorders or substance abuse.
The study, sponsored by Ailin Luo and conducted at Tongji Hospital, Wuhan, China, began in May 2021 and is estimated to be completed by December 2023.
The primary outcome measure is the Edinburgh Postnatal Depression Scale (EPDS) score, assessed up to 90 days post-surgery. Secondary outcome measures include pain intensity assessed by the Visual Analogue Scale (VAS) score and analgesic requirements measured by the total number and volume of patient-controlled analgesia (PCA) drugs administered within 24 hours post-surgery.
Trial Details
This study was to explore the preventive effect of esketamine on postpartum depression in cesarean section, and to evaluate the safety of the drugTrial Number NCT04860661