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临床试验 NCT07501728 针对Postpartum Depression (PPD)目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Intranasal Dexmedetomidine for Postpartum Depression Prevention 270 无创 随机化 双盲 安慰剂对照
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临床试验NCT07501728是一项针对Postpartum Depression (PPD)的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年5月1日开始，预计招募270名患者。该研究由Chengdu Jinjiang Maternity and Child Health Hospital主导，计划于2027年4月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月30日。
简要概括
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 sche...显示更多
详细描述
- 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 ideatio...
官方标题
Intranasal Dexmedetomidine for Prevention of Postpartum Depression in Women Receiving Combined Spinal-Epidural Labor Analgesia: A Randomized Controlled Trial
疾病
Postpartum Depression (PPD)出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- 202510
NCT编号
实际开始日期
2026-05-01
最近更新发布
2026-03-30
预计完成日期
2027-04-01
计划入组人数
270
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Postpartum Depression
Dexmedetomidine
Labor Analgesia
Dexmedetomidine
Labor Analgesia
主要目的
预防
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | 右美托咪定 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 ...显示更多 |
安慰剂对照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. | 安慰剂 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. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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. | 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). | 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). | 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. | 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. | 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. | At delivery, assessed on the day of delivery |
Incidence of Bradycardia | Proportion of participants with heart rate \< 60 bpm during labor and delivery. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 minute, 5 minutes, and 10 minutes after birth |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
- 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
- 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
Chengdu Jinjiang Maternity and Child Health Hospital研究责任方
Fei Jia, 主要研究者, Director of Anesthesiology Department, Chengdu Jinjiang Maternity and Child Health Hospital
研究中心联系人
联系人: Bo Liu, MS, +8618502846036, [email protected]
1 位于 1 个国家/地区的研究中心
Sichuan
Chengdu Jinjiang District Women & Children Health Hospital,, Chengdu, Sichuan, 610011, China
jianjun mao, BS, 联系人, +8615008460156, [email protected]