Intranasal Dexmedetomidine for Postpartum Depression Prevention

Starting soon · Not applicable · Has a placebo group

Conditions studied: Postpartum Depression (PPD)

In brief

Brief Title: Intranasal Dexmedetomidine for Postpartum Depression Prevention: A Randomized Trial This study aims to evaluate the effect of intranasal dexmedetomidine (Dex) administered before combined spinal-epidural labor analgesia on the incidence of postpartum depression (PPD) in women undergoing vaginal delivery. This prospective, randomized, double-blind, placebo-controlled trial will enroll 270 parturients scheduled for vaginal delivery with neuraxial labor analgesia at Chengdu Jinjiang Maternal and Child Health Hospital from 2026 to 2027. Participants will be randomly assigned in a 1:1 ratio to receive either intranasal Dex (50 μg) or an equal volume of normal saline before the initiation of labor analgesia. Primary Outcome Measure: Incidence of PPD at 42 days postpartum, defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 Secondary Outcome Measures: Incidence of PPD at 7 days postpartum (EPDS ≥ 10) Sleep quality assessed by Numerical Rating Scale (NRS) and incidence of sleep disturbance (NRS ≥ 6) at 7 and 42 days postpartum Analgesic effect: NRS pain scores before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia Sedative effect: Ramsay Sedation Scale scores at the same time points Adverse events: bradycardia, hypotension, nausea/vomiting, respiratory depression, oversedation, intrapartum fever Labor characteristics: duration of first, second, and third stages of labor, and total labor duration Duration of labor analgesia Mode of delivery: spontaneous vaginal delivery or cesarean section Neonatal outcomes: Apgar scores at 1, 5, and 10 minutes, and NICU admission rate We hypothesize that intranasal Dex administered before labor analgesia will significantly reduce the incidence of PPD at 42 days postpartum compared to placebo. This study is expected to provide a novel, non-invasive, and effective strategy for PPD prevention in women undergoing vaginal delivery, thereby improving maternal mental health and neonatal outcomes.

Key facts

Study ID: NCT07501728
Run by: Chengdu Jinjiang Maternity and Child Health Hospital
People needed: 270
Starts: 2026-05-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

ASA physical status II or III.
Age ≥ 18 years.
Singleton pregnancy, cephalic presentation
No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia for planned vaginal delivery

You may not qualify if…

History of bipolar disorder, psychiatric disorders, or suicidal ideation
Severe cardiac, cerebral, hepatic, or renal disease
Allergy to α2-adrenergic receptor agonists
Baseline bradycardia (heart rate < 60 bpm) or cardiac conduction abnormalities before labor analgesia
Hypotension (systolic blood pressure < 90 mmHg) before labor analgesia
History of drug or alcohol abuse
Severe rhinitis or nasal cavity deformity

Where it is running

Chengdu Jinjiang District Women & Children Health Hospital, — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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