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

Primary Purpose

Postpartum Depression

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esketamine
Sufentanil
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Esketamine, Epidural labor analgesia, Postpartum depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women's hospital, school of medicine, Zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esketamine Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2023
Last Updated
May 25, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05826327
Brief Title
Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Esketamine, Epidural labor analgesia, Postpartum depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
364 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esketamine Group
Arm Type
Experimental
Arm Description
The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with esketamine 0.3mg/mL.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with sufentanil 0.3ug/mL.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
E
Intervention Description
The drug esketamine will be added to the experimental group as opposed to the control group.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Other Intervention Name(s)
C
Intervention Description
Sufentanil for labour analgesia in the control group
Primary Outcome Measure Information:
Title
Incidence of depression
Description
The incidence (MINI-6.0 for the diagnosis of postnatal depression) and severity of depression on day 42 after delivery in both groups.
Time Frame
Day 42 after completion of labour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinzhong Chen, Dr
Phone
0571-8999100
Email
chenxinz@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiguo Lyv, Dr
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Women's hospital, school of medicine, Zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
331000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinzhong Chen, Dr
Phone
13575738058
Email
chenxinz@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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