Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826327
• Other study ID #: IRB-20230021-R
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Xinzhong Chen, Dr
• Phone: 0571-8999100
• Email: chenxinz[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

The study include women who meet the inclusion criteria for antenatal EPDS score ≥10 for labour analgesia while signing informed consent. The women will be randomized into two groups, one for esketamine group and the other for the control group. Follow-up visits will be conducted at 1 day, 7 days and 42 days after delivery. The primary endpoint of the study was the incidence (MINI-6.0 for diagnosis of postnatal depression) and severity of maternal depression at day 42 postpartum. The secondary endpoints of the study are maternal EPDS scores at 7 and 42 days postpartum; pain scores and impact at 1, 7 and 42 days postpartum; breastfeeding at 1, 7 and 42 days postpartum; length of postpartum stay; maternal complications at 42 days postpartum and neonatal illnesses at 42 days postpartum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pre-existing history of definite psychiatric disorders (depression, schizophrenia, etc.) or communication disorders;Presence of severe preoperative pregnancy complications (e.g., severe preeclampsia, placental implantation, HELLP syndrome, placenta praevia, placenta abruptio);ASA classification = grade III;Contraindications to ketamine/S-ketamine (e.g., intractable, refractory hypertension, severe cardiovascular disease [cardiac function class = III], hyperthyroidism); Refusal to participate in the study.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Esketamine
The drug esketamine will be added to the experimental group as opposed to the control group.
• Sufentanil
Sufentanil for labour analgesia in the control group

Locations

Country	Name	City	State
China	Women's hospital, school of medicine, Zhejiang university	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Beijing Obstetrics and Gynecology Hospital, Obstetrics & Gynecology Hospital of Fudan University, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of depression	The incidence (MINI-6.0 for the diagnosis of postnatal depression) and severity of depression on day 42 after delivery in both groups.	Day 42 after completion of labour