Intranasal Dexmedetomidine for Postpartum Depression Prevention

March 24, 2026 updated by: Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital

Intranasal Dexmedetomidine for Prevention of Postpartum Depression in Women Receiving Combined Spinal-Epidural Labor Analgesia: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Background Postpartum depression (PPD) is a common and serious mental health disorder affecting approximately 10% to 20% of women globally, with reported rates as high as 25% in China and up to 40% to 48% in socioeconomically disadvantaged regions. PPD typically occurs within the first few weeks to months after childbirth, with symptoms including persistent low mood, feelings of worthlessness, and suicidal ideation. PPD not only affects maternal mental health but is also a major contributor to pregnancy-related deaths, accounting for up to 68% of such cases. Furthermore, PPD negatively impacts infant emotional, cognitive, and social development, disrupts maternal-infant bonding, and increases family economic burden.

    Dexmedetomidine (Dex) is a highly selective α2-adrenergic receptor agonist with sedative, anxiolytic, analgesic, and sympatholytic properties. Studies have shown that Dex can inhibit excessive norepinephrine release, reduce pro-inflammatory cytokines, increase anti-inflammatory cytokines, and upregulate brain-derived neurotrophic factor (BDNF), thereby alleviating stress and inflammatory responses and improving depressive symptoms. Numerous clinical studies have demonstrated that Dex administered during cesarean section significantly reduces the incidence of PPD. However, no studies have investigated the effect of Dex on PPD prevention in women undergoing vaginal delivery.

    Intranasal administration offers advantages including rapid absorption, high bioavailability (82%), non-invasiveness, patient acceptability, and avoidance of first-pass hepatic metabolism. A previous study found that intranasal Dex (0.5 μg/kg) before labor analgesia improved epidural analgesic effects and reduced procedural pain during epidural puncture. Therefore, intranasal Dex may have potential for reducing PPD in women undergoing vaginal delivery, but high-quality clinical evidence is currently lacking.

  2. Objectives Primary Objective: To evaluate the effect of intranasal dexmedetomidine administered before combined spinal-epidural labor analgesia on the incidence of PPD at 42 days postpartum in women undergoing vaginal delivery.

    Secondary Objectives: To evaluate the effect of intranasal Dex on the incidence of PPD at 7 days postpartum, postpartum sleep quality, labor analgesic efficacy, safety (adverse event rates), labor characteristics, mode of delivery, and neonatal outcomes.

  3. Study Design This is a prospective, randomized, double-blind, placebo-controlled, single-center superiority trial with a 1:1 allocation ratio, conducted at Chengdu Jinjiang Maternal and Child Health Hospital.
  4. Intervention Participants in the experimental arm receive a single dose of intranasal dexmedetomidine 50 μg (25 μg per nostril) immediately before initiation of combined spinal-epidural labor analgesia. Participants in the comparator arm receive an equal volume of intranasal normal saline (one spray per nostril), identical in appearance, color, odor, and packaging to the active intervention.
  5. Labor Analgesia Protocol After cervical dilation ≥ 1 cm, combined spinal-epidural analgesia is performed at the L3-4 interspace. Following epidural puncture, 2 mL of 0.1% ropivacaine with 0.5 μg/mL sufentanil is administered intrathecally, and an epidural catheter is advanced 3-5 cm. A test dose of 3 mL 1.5% lidocaine is injected. After 30 minutes of observation, a patient-controlled epidural analgesia pump is connected. The pump is programmed for programmed intermittent epidural bolus mode with a solution of 0.1% ropivacaine + 0.5 μg/mL sufentanil. Pump settings: pulse dose 8 mL/h, background infusion 2 mL/h, patient-controlled bolus 5 mL, lockout interval 20 minutes, maximum hourly limit 25 mL.
  6. Randomization and Blinding Participants are randomized in a 1:1 ratio using a computer-generated random sequence with a block size of 4. Allocation is concealed in sequentially numbered, opaque, sealed envelopes. 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.
  7. Sample Size Calculation Based on preliminary clinical observations at the study center, the incidence of PPD at 42 days postpartum among women receiving labor analgesia for vaginal delivery is approximately 30%. The investigators hypothesize that intranasal Dex will reduce the PPD incidence by 50% relative (from 30% to 15%, an absolute reduction of 15%). Assuming a two-sided α of 0.05, power (1-β) of 0.80, and a 10% dropout rate, a sample size of 135 participants per group (270 total) is required, calculated using PASS 2023 software.

  8. Statistical Analysis Statistical analysis will be performed using R software (version 4.3.1). The primary analysis will be based on the modified intention-to-treat (mITT) principle, with the mITT population defined as randomized participants who received the intranasal intervention and completed at least one postpartum follow-up. Participants who undergo intrapartum cesarean section will remain in their original groups for analysis. No imputation will be performed for missing data due to loss to follow-up; complete case analysis will be used instead.

    Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. Normally distributed variables will be presented as mean ± standard deviation and analyzed using independent sample t-tests. Non-normally distributed variables will be presented as median with interquartile range and analyzed using rank-sum tests. Categorical variables will be presented as percentages and analyzed using chi-square tests or Fisher's exact tests. A P-value < 0.05 will be considered statistically significant.

  9. Ethical Consideration The study has been reviewed and approved by the Ethics Committee of Chengdu Jinjiang Maternal and Child Health Hospital (Approval Number: 202510). Written informed consent will be obtained from all participants prior to enrollment. All study procedures will strictly adhere to relevant ethical standards and regulations to safeguard participant safety and privacy.
  10. Expected Outcomes The investigators anticipate that intranasal Dex administered before labor analgesia will significantly reduce the incidence of PPD in women undergoing vaginal delivery and improve maternal mental health and quality of life. Specifically, the Dex group is expected to have a significantly lower incidence of PPD compared to the control group, with superior EPDS scores at 7 and 42 days postpartum and better sleep quality. Additionally, the Dex group is expected to demonstrate better pain management during labor without significantly increased adverse events, and neonatal outcomes are expected to be comparable between groups.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610011
        • Chengdu Jinjiang District Women & Children Health Hospital,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Dexmedetomidine Group
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
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.
Placebo Comparator: Placebo (Normal Saline) Intranasal
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postpartum Depression at 42 Days Postpartum
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postpartum Depression at 7 Days Postpartum
Time Frame: At 7 days postpartum
Proportion of participants with Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 at 7 days postpartum. EPDS total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
At 7 days postpartum
Postpartum Sleep Quality
Time Frame: 7 days and 42 days postpartum
Sleep quality assessed by Numerical Rating Scale (NRS) at 7 and 42 days postpartum. NRS ranges from 0 to 10, with 0 indicating best sleep and 10 indicating worst sleep. Sleep disturbance is defined as NRS ≥ 6.
7 days and 42 days postpartum
Pain Scores During Labor
Time Frame: Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Pain intensity assessed by Numerical Rating Scale (NRS) before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia. NRS ranges from 0 (no pain) to 10 (worst pain imaginable).
Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Sedation Scores During Labor
Time Frame: Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Sedation level assessed by Ramsay Sedation Scale before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia. Ramsay scale ranges from 1 (anxious/agitated) to 6 (no response).
Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Labor Characteristics
Time Frame: During labor and delivery, assessed up to 24 hours
Duration of first, second, and third stages of labor, and total labor duration.
During labor and delivery, assessed up to 24 hours
Duration of Labor Analgesia
Time Frame: From initiation of analgesia to delivery or discontinuation, assessed up to 24 hours
Total duration from initiation of labor analgesia to delivery or discontinuation of analgesia.
From initiation of analgesia to delivery or discontinuation, assessed up to 24 hours
Mode of Delivery
Time Frame: At delivery, assessed on the day of delivery
Proportion of participants with spontaneous vaginal delivery or cesarean section.
At delivery, assessed on the day of delivery
Incidence of Bradycardia
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants with heart rate < 60 bpm during labor and delivery.
During labor and delivery, assessed up to 24 hours
Incidence of Hypotension
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants with systolic blood pressure < 90 mmHg during labor and delivery.
During labor and delivery, assessed up to 24 hours
Incidence of Nausea and Vomiting
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants experiencing nausea or vomiting during labor and delivery.
During labor and delivery, assessed up to 24 hours
Incidence of Respiratory Depression
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants with oxygen saturation (SpO₂) < 90% during labor and delivery.
During labor and delivery, assessed up to 24 hours
Incidence of Oversedation
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants with Ramsay Sedation Scale score ≥ 4 during labor and delivery.
During labor and delivery, assessed up to 24 hours
Incidence of Intrapartum Fever
Time Frame: During labor and delivery, assessed up to 24 hours
Proportion of participants with body temperature ≥ 38.0°C during labor and delivery.
During labor and delivery, assessed up to 24 hours
NICU Admission Rate
Time Frame: During hospital stay after birth, assessed up to 7 days
Proportion of neonates admitted to the neonatal intensive care unit (NICU) during hospital stay.
During hospital stay after birth, assessed up to 7 days
Neonatal Apgar Scores
Time Frame: 1 minute, 5 minutes, and 10 minutes after birth
Neonatal Apgar scores assessed at 1 minute, 5 minutes, and 10 minutes after birth. Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition.
1 minute, 5 minutes, and 10 minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Jinjiang Maternity and Child Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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