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Clinical Evaluation of the Effect of Low-dose Esketamine on Perinatal Depression Symptoms after Delivery: A Prospective Randomized Controlled Study

Clinical Evaluation of the Effect of Low-dose Esketamine on Perinatal Depression Symptoms after Delivery: A Prospective Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107385
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women who are admitted to the hospital in the third trimester for delivery preparation, have an EPDS score of =10 points, and are scheduled for elective cesarean section.

Interventions

The Esketamine Group:After the fetus is delivered and the umbilical cord is cut, 5 ml of 0.2 mg/kg esketamine is injected through the established intravenous indwelling needle channel. After the cesar
The Normal Saline Group:After the fetus is removed and the umbilical cord is cut, 5 ml of 0.9% sodium chloride injection is administered intravenously through the venous access. After the cesarean sec

Sponsors

The Second Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Aged >=18 years old, with full capacity for civil conduct, capable of understanding and signing the informed consent form; women undergoing elective cesarean section; admitted to the hospital in the late stage of pregnancy (gestational age =37 weeks) for labor; with a score of =10 on the Edinburgh Postnatal Depression Scale (EPDS) at admission, indicating the presence of prenatal depression symptoms; with an ASA (American Society of Anesthesiologists) classification of I-II, able to accept postoperative PCA analgesia management; agree to participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: A clear history of mental illness diagnosis in the past (such as major depressive disorder, schizophrenia, bipolar disorder, etc.); currently taking antidepressants, antipsychotics or other drugs that affect the central nervous system; having severe complications during pregnancy (such as severe preeclampsia, placental abruption, HELLP syndrome, etc.); allergic to ketamine or sufentanil and other anesthetic analgesic drugs, or having related contraindications; having severe heart, liver, kidney function disorders or a history of epilepsy; ASA classification >= III, not suitable for postoperative PCA analgesia treatment; having a history of drug abuse or other behaviors that may interfere with the judgment of research results; unwilling to cooperate with the research or expected to be unable to complete the research follow-up.

Design outcomes

Primary

MeasureTime frame
The improvement rate of EPDS score within 30 days postpartum;

Secondary

MeasureTime frame
Adverse reactions: nausea, vomiting, dizziness, respiratory depression, mental side effects, etc.;Pain relief effect and total dosage of opioids: VAS/NRS pain relief scores were conducted at 6 hours, 24 hours, and 48 hours postoperatively, and the total dosage of opioids during the pain relief period was recorded simultaneously.;Patient satisfaction: On the third day and the thirtieth day postpartum, the patients' subjective satisfaction with the improvement of their mood, pain relief experience and overall recovery was evaluated.;Emotional indicators: The degree of depressive symptoms in postpartum women was evaluated using the EPDS and HAMD-17 scales respectively on the 30th day after delivery.;

Countries

China

Contacts

Public ContactCaihua Zeng

The Second Affiliated Hospital of Guangdong Medical University

1395047887@qq.com+86 138 2712 4022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026