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

NCT ID: NCT05826327

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

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 .

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.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Esketamine Group

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

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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

Control Group

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

Group Type: PLACEBO_COMPARATOR

Sufentanil

Intervention Type: DRUG

Sufentanil for labour analgesia in the control group

Interventions

Esketamine

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

Intervention Type: DRUG

Sufentanil

Sufentanil for labour analgesia in the control group

Intervention Type: DRUG

Other Intervention Names

E; C

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiguo Lyv, Dr

Role: STUDY_DIRECTOR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's hospital, school of medicine, Zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinzhong Chen, Dr

Role: CONTACT

chenxinz@zju.edu.cn

0571-8999100

Facility Contacts

Xinzhong Chen, Dr

Role: primary

chenxinz@zju.edu.cn

13575738058

Other Identifiers

IRB-20230021-R

Identifier Type: -

Identifier Source: org_study_id