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

NCT05826327 | Recruiting Phase 4 DMC

• 1 other identifier: IRB-20230021-R
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Postpartum Depression

Keywords

Esketamine; Epidural labor analgesia; Postpartum depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Esketamine Group

EXPERIMENTAL

The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with esketamine 0.3mg/mL.

Drug: Esketamine

Control Group

PLACEBO COMPARATOR

The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with sufentanil 0.3ug/mL.

Drug: Sufentanil

Interventions

Esketamine DRUG

The drug esketamine will be added to the experimental group as opposed to the control group.

Also known as: E

Esketamine Group

Sufentanil DRUG

Sufentanil for labour analgesia in the control group

Also known as: C

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Peking University First Hospital: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator

Study Sites (1)

Women's hospital, school of medicine, Zhejiang university

Hangzhou, Zhejiang, 331000, China

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Esketamine; Sufentanil

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Weiguo Lyv, Dr

  Women's Hospital School Of Medicine Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Xinzhong Chen, Dr

CONTACT

0571-8999100; chenxinz@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-05

Locations

CN (1)