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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression
• Intervention / Treatment: Drug: Esketamine; Drug: Sufentanil

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 364
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xinzhong Chen, Dr; Phone Number: 0571-8999100; Email: chenxinz@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 331000
      • Recruiting
      • Women's Hospital, School of Medicine, Zhejiang University
      • Contact: Xinzhong Chen, Dr; Phone Number: 13575738058; Email: chenxinz@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esketamine Group; The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with esketamine 0.3mg/mL.	Drug: Esketamine; The drug esketamine will be added to the experimental group as opposed to the control group.; Other Names: E
Placebo Comparator: Control Group; The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with sufentanil 0.3ug/mL.	Drug: Sufentanil; Sufentanil for labour analgesia in the control group; Other Names: C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Peking University First Hospital; Obstetrics & Gynecology Hospital of Fudan University; Beijing Obstetrics and Gynecology Hospital
• Investigators: Study Director: Weiguo Lyv, Dr, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Postpartum depression; Esketamine; Epidural labor analgesia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Adjuvants, Anesthesia; Esketamine; Sufentanil
• Other Study ID Numbers: IRB-20230021-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No