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Unknown statusPhase 4

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

NCT05826327 · Women's Hospital School Of Medicine Zhejiang University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
364
Target enrolment
1
Study sites
Outside the US

What it is testing

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 .

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of depression

    Measured over Day 42 after completion of labour

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
FEMALE
Sex
Not accepted
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.

Where

1 study site

FacilityCityRegionCountry
Women's hospital, school of medicine, Zhejiang universityHangzhouZhejiangChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05826327 on ClinicalTrials.gov →

Last updated in the registry 2024-08-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits