Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression and Maternal and Neonatal Outcomes in Parturients With Prenatal Depression

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Postpartum depression is a common psychological abnormality during the puerperium, which seriously affects maternal and neonatal health. Esketamine, the S-enantiomer of ketamine, is twice as potent as ketamine and can be safely used for cesarean section and labor analgesia. However, it is not clear whether esketamine used for epidural labor analgesia can significantly reduce the incidence of postpartum depression. This study intends to explore the incidence of maternal prenatal depression and to investigate the effect of esketamine for epidural labor analgesia on postpartum depression and maternal and neonatal outcomes in parturients with prenatal depression through a multi-center, large-scale and high-quality clinical trail, in order to provide a clinical basis and theoretical basis for the application of esketamine used for epidural labor analgesia in postpartum depression and further reduce the incidence of postpartum depression, promote maternal and infant health, and ensure maternal and infant safety .

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Full-term pregnancy; Antenatal depressive state (EPDS score ≥10 and non-depressive diagnosis by a psychiatrist); Epidural labor analgesia; Signed informed consent.

Locations
Other Locations
China
Women's hospital, school of medicine, Zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
Xinzhong Chen, Dr
chenxinz@zju.edu.cn
0571-8999100
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 364
Treatments
Experimental: Esketamine Group
The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with esketamine 0.3mg/mL.
Placebo_comparator: Control Group
The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with sufentanil 0.3ug/mL.
Related Therapeutic Areas
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Obstetrics & Gynecology Hospital of Fudan University, Peking University First Hospital, Beijing Obstetrics and Gynecology Hospital

This content was sourced from clinicaltrials.gov