Effect of Tramadol in Prevention of Postpartum Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,230
- 试验地点
- 1
- 主要终点
- The incidence of postpartum depression
研究概览
简要总结
The incidence of postpartum depression in Europe and the United States is about 10%, while in China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common diseases of perinatal distress, but the current research of high-quality prevention and treatment of postpartum depression is still very lack. The study suggests that the risk of postpartum depression in cesarean delivery is significantly higher than that in vaginal delivery. Therefore, postpartum depression in cesarean delivery may require more attention and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain, and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the potential to reduce depression and anxiety. Therefore, for the analgesic demand and antidepressant demand for maternal who undergoing cesarean section, tramadol may be an optimized and effective analgesic for the prevention and treatment of postpartum depression.
详细描述
This study was designed according to a prospective, randomized, controlled clinical trial. Randomized subjects were randomly assigned to different analgesic drug-treated groups according to the random number induced by SPSS software. All three analgesic treatments were routinely used for clinical analgesia; Anesthesia, surgery, postoperative treatment are in accordance with clinical practice. The investigators conducted a postoperative questionnaire survey and psychological diagnosis for all patients. And blood sample was collected from patients before and 48 hours after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20 years old ≤ age ≤ 40 years old;
- •ASA score I-Ⅱ;
- •uncomplicated and singleton full-term pregnancy;
- •voluntarily to receive cesarean section and postoperative controlled analgesia;
- •consent to participate the study.
排除标准
- •with history of mental disorders or psychotropic substances use;
- •with history of neurological diseases such as epilepsy
- •with history of previously known diagnosed depression;
- •with suicidal ideation or history of suicide;
- •with history of drug，alcohol or opioid abuse;
- •with monoamine oxidase (MAO) inhibitor treatment at present or in the past 14 days;
- •participating in other clinical studies
- •with severe heart disease, brain disease, liver disease and kidney disease;
- •be allergic to tramadol or opioids;
- •with any contraindication for combined spinal epidural anesthesia;
- •incapable of communication or cooperation.
研究组 & 干预措施
Group T
All patients receive the patient-controlled intravenous analgesia with Tramadol.
干预措施: Tramadol (Drug)
Group H
All patients receive the patient-controlled intravenous analgesia with Hydromorphone.
干预措施: Hydromorphone (Drug)
Group E
All patients receive the patient-controlled epidural analgesia with Ropivacaine.
干预措施: Ropivacaine (Epidural analgesia) (Drug)
结局指标
主要结局
The incidence of postpartum depression
时间窗: At 4 weeks after the surgery
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
次要结局
- Pain intensity(At 6, 12, 24 and 48 hours after the surgery)
- Norepinephrine and serotonin levels in the blood(At 48 hours after the surgery)
- EPDS scores(At 4 weeks and 3 months after the surgery)
- The incidence of postpartum depression(At 3 months after the surgery)
- GAD-7 scores(At 4 weeks and 3 months after the surgery)
- QoR-15 scores(48 hours after the surgery)
研究者
Hong Li
Director, Department of Anesthesiology
Xinqiao Hospital of Chongqing