Effect of a single low-dose dose of esketamine on postpartum depression and quality of recovery in women undergoing cesarean section: a prospective, randomised controlled study
This randomised, parallel-group trial (n=136) is evaluating whether a single low-dose infusion of esketamine after caesarean section can reduce postpartum depressive symptoms and improve recovery in women in China. Participants are allocated to receive intravenous esketamine 0.2 mg/kg over 40 minutes after surgery or an intravenous physiological saline infusion for the same duration as the comparator. The study is interventional and involves adult women aged 18 to 60 years undergoing caesarean delivery. The primary outcome is the Edinburgh Postnatal Depression Scale (EPDS) score, assessed on postpartum day 2 and postpartum day 7. Secondary outcomes include the Obstetric Quality of Recovery-10 (ObsQoR-10) score at 24 and 48 hours postpartum, resting and exercise pain scores measured using a visual analogue scale at 24 hours postpartum, and postpartum length of hospital stay. No phase is specified. The trial is being conducted in China and is sponsored by Dongguan Maternal and Child Health Hospital.
Detailed Description
Main research objectives
Evaluation of the effect of single low-dose ketamine on postpartum depression score in cesarean section women after delivery
Secondary research objectives
Evaluation of the effect of single low-dose ketamine on postpartum recovery quality in cesarean section women
Study Details
- StatusNot yet recruiting
- PhasePhase NA
- Typeinterventional
- DesignRandomized
- Target Enrollment68 participants
- TimelineStart: 2024-09-01End: 2025-03-31
- Topic