Using esketamine for epidural labor pain relief to reduce postpartum depression
Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression and Maternal and Neonatal Outcomes in Parturients With Prenatal Depression
PHASE4 · Women's Hospital School Of Medicine Zhejiang University · NCT05826327
This study is testing if using esketamine for pain relief during labor can help reduce the chances of postpartum depression in women who had depression symptoms before giving birth.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05826327 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of esketamine, a potent form of ketamine, administered through epidural labor analgesia on the incidence of postpartum depression in women with antenatal depressive symptoms. Participants will be randomly assigned to receive either esketamine or a control treatment during labor, and their mental health will be monitored through follow-up visits at 1, 7, and 42 days postpartum. The primary focus is to assess the incidence and severity of postpartum depression, while secondary outcomes include pain management, breastfeeding success, and maternal and neonatal health indicators. The study aims to provide a clinical basis for the use of esketamine in labor analgesia to improve maternal and infant health outcomes.
Who should consider this trial
Good fit: Ideal candidates are women with full-term pregnancies who have an antenatal EPDS score of 10 or higher and are seeking epidural labor analgesia.
Not a fit: Patients with pre-existing psychiatric disorders or severe pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postpartum depression, enhancing the well-being of new mothers and their infants.
How similar studies have performed: While the use of esketamine in this context is relatively novel, previous studies have shown promising results with ketamine in treating depression, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Women's hospital, school of medicine, Zhejiang university — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Xinzhong Chen, Dr
- Email: chenxinz@zju.edu.cn
- Phone: 0571-8999100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Depression, Esketamine, Epidural labor analgesia, Postpartum depression