Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT05826327

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

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2024-08-20

364

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

W

Women's Hospital School Of Medicine Zhejiang University

Lead Sponsor

P

Peking University First Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Full-term pregnancy
  • Antenatal depressive state with EPDS score of 10 or higher and no depressive diagnosis by a psychiatrist
  • Planned epidural labor analgesia
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of definite psychiatric disorders such as depression or schizophrenia
  • Presence of severe pregnancy complications including severe preeclampsia, placental implantation, HELLP syndrome, placenta praevia, or placenta abruptio
  • ASA classification of grade III or higher
  • Contraindications to ketamine or S-ketamine such as refractory hypertension, severe cardiovascular disease (cardiac function class III or higher), or hyperthyroidism
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Women's hospital, school of medicine, Zhejiang university

Hangzhou, Zhejiang, China, 331000

Actively Recruiting

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Research Team

X

Xinzhong Chen, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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