Postpartum Depression (PPD)NCT07501728
Intranasal Dexmedetomidine for Postpartum Depression Prevention
A study testing Dexmedetomidine in people with Postpartum Depression (PPD), run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu Jinjiang District Women & Children Health Hospital,
Chengdu, Sichuan, 610011
jianjun mao, BS, +8615008460156, anesthesiologyzj@163.com
About this study
Official title: 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:
Read more
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Postpartum Depression, Dexmedetomidine, Labor Analgesia
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 42 days postpartum
Secondary outcomes (15)
Incidence of Postpartum Depression 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.
Measured: At 7 days postpartum
Postpartum Sleep Quality
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.
Measured: 7 days and 42 days postpartum
Pain Scores During Labor
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).
Measured: Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Sedation Scores During Labor
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).
Measured: Before analgesia, 30 minutes, 1 hour, and 3 hours after analgesia
Labor Characteristics
Duration of first, second, and third stages of labor, and total labor duration.
Measured: During labor and delivery, assessed up to 24 hours
Duration of Labor Analgesia
Total duration from initiation of labor analgesia to delivery or discontinuation of analgesia.
Measured: From initiation of analgesia to delivery or discontinuation, assessed up to 24 hours
Mode of Delivery
Proportion of participants with spontaneous vaginal delivery or cesarean section.
Measured: At delivery, assessed on the day of delivery
Incidence of Bradycardia
Proportion of participants with heart rate < 60 bpm during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
Incidence of Hypotension
Proportion of participants with systolic blood pressure < 90 mmHg during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
Incidence of Nausea and Vomiting
Proportion of participants experiencing nausea or vomiting during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
Incidence of Respiratory Depression
Proportion of participants with oxygen saturation (SpO₂) < 90% during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
Incidence of Oversedation
Proportion of participants with Ramsay Sedation Scale score ≥ 4 during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
Incidence of Intrapartum Fever
Proportion of participants with body temperature ≥ 38.0°C during labor and delivery.
Measured: During labor and delivery, assessed up to 24 hours
NICU Admission Rate
Proportion of neonates admitted to the neonatal intensive care unit (NICU) during hospital stay.
Measured: During hospital stay after birth, assessed up to 7 days
Neonatal Apgar Scores
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.
Measured: 1 minute, 5 minutes, and 10 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501728
- Sponsor's protocol ID
- 202510
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
PubMed 17646493Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT, Jusko WJ. Mechanism-based population pharmacokinetic and pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin Pharmacol. 2015 Oct;71(10):1197-207. doi: 10.1007/s00228-015-1913-0. Epub 2015 Aug 2.
PubMed 26233335Kuang Y, Wang SY, Wang MN, Yang GP, Guo C, Yang S, Zhang XF, Yang XY, Pei Q, Zou C, He YH, Zhou YY, Duan KM, Huang J. Safety, Pharmacokinetics/Pharmacodynamics, and Absolute Bioavailability of Dexmedetomidine Hydrochloride Nasal Spray in Healthy Subjects: A Randomized, Parallel, Escalating Dose Study. Front Pharmacol. 2022 May 20;13:871492. doi: 10.3389/fphar.2022.871492. eCollection 2022.
PubMed 35668951Sun H, Ma X, Wang S, Li Z, Lu Y, Zhu H. Low-dose intranasal dexmedetomidine premedication improves epidural labor analgesia onset and reduces procedural pain on epidural puncture: a prospective randomized double-blind clinical study. BMC Anesthesiol. 2023 May 30;23(1):185. doi: 10.1186/s12871-023-02146-5.
PubMed 37254106Wang Y, Fang X, Liu C, Ma X, Song Y, Yan M. Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial. Drug Des Devel Ther. 2020 Mar 11;14:1083-1093. doi: 10.2147/DDDT.S241153. eCollection 2020.
PubMed 32210537Liu H, Dai A, Zhou Z, Xu X, Gao K, Li Q, Xu S, Feng Y, Chen C, Ge C, Lu Y, Zou J, Wang S. An optimization for postpartum depression risk assessment and preventive intervention strategy based machine learning approaches. J Affect Disord. 2023 May 1;328:163-174. doi: 10.1016/j.jad.2023.02.028. Epub 2023 Feb 8.
PubMed 36758872Li S, Zhou W, Li P, Lin R. Effects of ketamine and esketamine on preventing postpartum depression after cesarean delivery: A meta-analysis. J Affect Disord. 2024 Apr 15;351:720-728. doi: 10.1016/j.jad.2024.01.202. Epub 2024 Jan 28.
PubMed 38286233Yu HY, Wang SY, Quan CX, Fang C, Luo SC, Li DY, Zhen SS, Ma JH, Duan KM. Dexmedetomidine Alleviates Postpartum Depressive Symptoms following Cesarean Section in Chinese Women: A Randomized Placebo-Controlled Study. Pharmacotherapy. 2019 Oct;39(10):994-1004. doi: 10.1002/phar.2320. Epub 2019 Sep 15.
PubMed 31411762Xu S, Zhou Y, Wang S, Li Q, Feng Y, Chen L, Duan K. Perioperative intravenous infusion of dexmedetomidine for alleviating postpartum depression after cesarean section: A meta-analysis and systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:333-341. doi: 10.1016/j.ejogrb.2024.03.024. Epub 2024 Mar 21.
PubMed 38531179Zhou Y, Bai Z, Zhang W, Xu S, Feng Y, Li Q, Li L, Ping A, Chen L, Wang S, Duan K. Effect of Dexmedetomidine on Postpartum Depression in Women With Prenatal Depression: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353252. doi: 10.1001/jamanetworkopen.2023.53252.
PubMed 38270949Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
PubMed 31668347Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.
PubMed 26063213Lee Y, Kim KH, Lee BH, Kim YK. Plasma level of brain-derived neurotrophic factor (BDNF) in patients with postpartum depression. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jul 13;109:110245. doi: 10.1016/j.pnpbp.2021.110245. Epub 2021 Jan 11.
PubMed 33444650Groer MW, Morgan K. Immune, health and endocrine characteristics of depressed postpartum mothers. Psychoneuroendocrinology. 2007 Feb;32(2):133-9. doi: 10.1016/j.psyneuen.2006.11.007. Epub 2007 Jan 3.
PubMed 17207585Boufidou F, Lambrinoudaki I, Argeitis J, Zervas IM, Pliatsika P, Leonardou AA, Petropoulos G, Hasiakos D, Papadias K, Nikolaou C. CSF and plasma cytokines at delivery and postpartum mood disturbances. J Affect Disord. 2009 May;115(1-2):287-92. doi: 10.1016/j.jad.2008.07.008. Epub 2008 Aug 15.
PubMed 18708264
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine for Prevention of Postpartum Depression in Women Receiving Combined Spinal-Epidural Labor Analgesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07501728
- Acronym / sponsor ID
- 202510
- Conditions
- Postpartum Depression (PPD)
- Keywords
- Postpartum Depression, Dexmedetomidine, Labor Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine Group | Experimental | Drug: DexmedetomidineParticipants 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. |
| Placebo (Normal Saline) Intranasal | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineIntranasal 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. | Drug | Intranasal Dexmedetomidine Group |
| PlaceboIntranasal 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. | Drug | Placebo (Normal Saline) Intranasal |
Primary outcome
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.
15 secondary outcomes
Incidence of Postpartum Depression at 7 Days Postpartum
Time frame: At 7 days postpartum
Postpartum Sleep Quality
Time frame: 7 days and 42 days postpartum
Pain Scores During Labor
Time frame: 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
Labor Characteristics
Time frame: 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
Mode of Delivery
Time frame: At delivery, assessed on the day of delivery
Incidence of Bradycardia
Time frame: During labor and delivery, assessed up to 24 hours
Incidence of Hypotension
Time frame: 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
Incidence of Respiratory Depression
Time frame: During labor and delivery, assessed up to 24 hours
Incidence of Oversedation
Time frame: During labor and delivery, assessed up to 24 hours
Incidence of Intrapartum Fever
Time frame: During labor and delivery, assessed up to 24 hours
NICU Admission Rate
Time frame: During hospital stay after birth, assessed up to 7 days
Neonatal Apgar Scores
Time frame: 1 minute, 5 minutes, and 10 minutes after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 17646493Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
- Background: PubMed 26233335Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT, Jusko WJ. Mechanism-based population pharmacokinetic and pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin Pharmacol. 2015 Oct;71(10):1197-207. doi: 10.1007/s00228-015-1913-0. Epub 2015 Aug 2.
- Background: PubMed 35668951Kuang Y, Wang SY, Wang MN, Yang GP, Guo C, Yang S, Zhang XF, Yang XY, Pei Q, Zou C, He YH, Zhou YY, Duan KM, Huang J. Safety, Pharmacokinetics/Pharmacodynamics, and Absolute Bioavailability of Dexmedetomidine Hydrochloride Nasal Spray in Healthy Subjects: A Randomized, Parallel, Escalating Dose Study. Front Pharmacol. 2022 May 20;13:871492. doi: 10.3389/fphar.2022.871492. eCollection 2022.
- Background: PubMed 37254106Sun H, Ma X, Wang S, Li Z, Lu Y, Zhu H. Low-dose intranasal dexmedetomidine premedication improves epidural labor analgesia onset and reduces procedural pain on epidural puncture: a prospective randomized double-blind clinical study. BMC Anesthesiol. 2023 May 30;23(1):185. doi: 10.1186/s12871-023-02146-5.
- Background: PubMed 32210537Wang Y, Fang X, Liu C, Ma X, Song Y, Yan M. Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial. Drug Des Devel Ther. 2020 Mar 11;14:1083-1093. doi: 10.2147/DDDT.S241153. eCollection 2020.
- Background: PubMed 36758872Liu H, Dai A, Zhou Z, Xu X, Gao K, Li Q, Xu S, Feng Y, Chen C, Ge C, Lu Y, Zou J, Wang S. An optimization for postpartum depression risk assessment and preventive intervention strategy based machine learning approaches. J Affect Disord. 2023 May 1;328:163-174. doi: 10.1016/j.jad.2023.02.028. Epub 2023 Feb 8.
- Background: PubMed 38286233Li S, Zhou W, Li P, Lin R. Effects of ketamine and esketamine on preventing postpartum depression after cesarean delivery: A meta-analysis. J Affect Disord. 2024 Apr 15;351:720-728. doi: 10.1016/j.jad.2024.01.202. Epub 2024 Jan 28.
- Background: PubMed 31411762Yu HY, Wang SY, Quan CX, Fang C, Luo SC, Li DY, Zhen SS, Ma JH, Duan KM. Dexmedetomidine Alleviates Postpartum Depressive Symptoms following Cesarean Section in Chinese Women: A Randomized Placebo-Controlled Study. Pharmacotherapy. 2019 Oct;39(10):994-1004. doi: 10.1002/phar.2320. Epub 2019 Sep 15.
- Background: PubMed 38531179Xu S, Zhou Y, Wang S, Li Q, Feng Y, Chen L, Duan K. Perioperative intravenous infusion of dexmedetomidine for alleviating postpartum depression after cesarean section: A meta-analysis and systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:333-341. doi: 10.1016/j.ejogrb.2024.03.024. Epub 2024 Mar 21.
- Background: PubMed 38270949Zhou Y, Bai Z, Zhang W, Xu S, Feng Y, Li Q, Li L, Ping A, Chen L, Wang S, Duan K. Effect of Dexmedetomidine on Postpartum Depression in Women With Prenatal Depression: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353252. doi: 10.1001/jamanetworkopen.2023.53252.
- Background: PubMed 31668347Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
- Background: PubMed 26063213Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Postpartum Depression (PPD), run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Liu, MS (+8618502846036, liubojjfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postpartum Depression at 42 Days Postpartum (time frame: At 42 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07501728, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.