Intranasal Dexmedetomidine for Postpartum Depression Prevention

NCT07501728 | Not Yet Recruiting DMC

• 1 other identifier: 202510
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Depression (PPD)

Keywords

Postpartum Depression; Dexmedetomidine; Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Postpartum Depression at 42 Days Postpartum

  Proportion of participants with Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 at 42 days postpartum. EPDS total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.

  At 42 days postpartum

Secondary Outcomes (15)

• Incidence of Postpartum Depression at 7 Days Postpartum

  At 7 days postpartum

• Postpartum Sleep Quality

  7 days and 42 days postpartum

• Pain Scores During Labor

  Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia

• Sedation Scores During Labor

  Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia

• Labor Characteristics

  During labor and delivery, assessed up to 24 hours

Study Arms (2)

Intranasal Dexmedetomidine Group

EXPERIMENTAL

Participants in this arm will receive a single dose of intranasal dexmedetomidine 50 μg (one spray of 25 μg per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.

Drug: Dexmedetomidine

Placebo (Normal Saline) Intranasal

PLACEBO COMPARATOR

Participants in this arm will receive a single dose of intranasal normal saline (one spray per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Intranasal dexmedetomidine 50 μg administered as a single dose immediately before initiation of Combined Spinal-Epidural labor analgesia. The drug is delivered via nasal spray device, with one spray of 25 μg in each nostril (total two sprays). The intervention is prepared and administered by the attending anesthesiologist who is aware of group allocation but does not participate in postoperative follow-up or outcome assessment.

Intranasal Dexmedetomidine Group

Placebo DRUG

Intranasal normal saline (one spray per nostril, total two sprays) administered as a single dose before initiation of Combined Spinal-Epidural labor analgesia. Identical in appearance, color, odor, and packaging to the dexmedetomidine nasal spray to maintain blinding.

Placebo (Normal Saline) Intranasal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chengdu Jinjiang Maternity and Child Health Hospital: lead

Study Sites (1)

Chengdu Jinjiang District Women & Children Health Hospital,

Chengdu, Sichuan, 610011, China

Location

Related Publications (24)

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MeSH Terms

Conditions

Depression, Postpartum

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bo Liu, MS

CONTACT

+8618502846036; liubojjfy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The attending anesthesiologist who prepares and administers the study drug is aware of group allocation (unblinded) but is not involved in any postoperative follow-up or outcome assessment. Participants, outcome assessors, data managers, and statisticians are blinded to group assignment. The intranasal sprays (dexmedetomidine 50 μg/0.2 mL or normal saline) are identical in appearance, color, odor, and packaging to ensure successful blinding of participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)