Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 881
- 试验地点
- 1
- 主要终点
- The incidence of major postnatal depression in both groups
研究概览
简要总结
Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. This study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.
详细描述
If the patients have not decided on which pain relief method to be used, and would like to take part in this study, they will be assigned to either epidural or non-epidural pain relief for labour based on the study randomization result. Blood samples will be drawn to study the presence of known functional polymorphisms in candidate genes associated with depression, pain, stress and anxiety. Patients will be followed up with study questionnaires related to pain and postnatal depression screening during the study. For some of the patients, a discrete choice experiment (DCE) on pain relief choice will be conducted, and their preferences on epidural analgesia will be asked.
During any time of the labour period, the patient is allowed to switch the pain relief option upon request.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous);
- •With a singleton fetus.
排除标准
- •Multiple pregnancies;
- •Non-cephalic fetal presentation;
- •Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes);
- •Elective and urgent caesarean section (not from delivery suite).
研究组 & 干预措施
Non-epidural group
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
干预措施: Entonox (Drug)
Epidural group
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
干预措施: Epidural delivery system (Device)
Epidural group
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
干预措施: Fentanyl (Drug)
Epidural group
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
干预措施: Ropivacaine (Drug)
Non-epidural group
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
干预措施: Meperidine (Drug)
Non-epidural group
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
干预措施: Ultiva (Drug)
结局指标
主要结局
The incidence of major postnatal depression in both groups
时间窗: 6-10 weeks after delivery
Edinburgh Postnatal Depression Scale (EPDS) score\>=13
The incidence of (clinically significant, probable) postnatal depression in both groups
时间窗: 6-10 weeks after delivery
Edinburgh Postnatal Depression Scale (EPDS) score\>=10
次要结局
- The incidence of acquiring post-delivery persistent pain in both groups(6-10 weeks after delivery)
- Pain vulnerability in both groups (1)(Upon recruitment until 6-10 weeks after delivery)
- Pain vulnerability in both groups (2)(Upon recruitment until 6-10 weeks after delivery)
- Pain vulnerability in both groups (3)(Upon recruitment till end of first stage of labor (1 day))
- Psychological vulnerability in both groups (1)(Upon recruitment until 5 days after delivery)
- Psychological vulnerability in both groups (2)(Upon recruitment until 5 days after delivery)
- Psychological vulnerability in both groups (3)(Upon recruitment until 5 days after delivery)
- Pain severity in both groups(During labour till one day after delivery)
- Preferences for labor analgesia(Prior to labor and delivery)
- Preferences for epidural analgesia(Prior to labor and delivery)
- Chinese version of Angle Labor Pain Questionnaire (A-LPQ)(Upon recruitment till end of first stage of labor (1 day))
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital