Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Score (EPDS)
研究概览
简要总结
The purpose of this pilot prospective randomized control trial is to compare the initiation of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on risk for postpartum depression symptoms. Investigators will randomize women to the receipt of CSE or E during labor, after measuring baseline psychological, psychosocial, and psychophysical factors related to pain and depression. The immediate research goals are to understand whether the association between labor pain and PPD is modifiable through the use of tailored anesthetic techniques.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous (no prior childbirth)
- •Singleton gestation
- •Third trimester
- •Healthy pregnancy
- •English proficiency (surveys validated in English)
- •Planned vaginal delivery
- •Planning to use labor epidural analgesia
- •Term delivery (>/= 37.0 weeks)
排除标准
- •Severe maternal disease
- •Severe fetal disease
- •Delivery not at term (delivery prior to 37.0 weeks)
- •Contraindications to neuraxial anesthesia known at the time of enrollment
- •Cesarean delivery WITHOUT labor
- •Planning to list infant for adoption
- •Did not receive epidural analgesia (either CSE or E) for labor
研究组 & 干预措施
CSE
intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
干预措施: CSE (Procedure)
CSE
intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
干预措施: Bupivacaine / fentaNYL (Drug)
Epidural
epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
干预措施: Epidural (Procedure)
Epidural
epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
干预措施: Bupivacaine / fentaNYL (Drug)
结局指标
主要结局
Edinburgh Postnatal Depression Score (EPDS)
时间窗: 6 weeks
Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.
次要结局
- Pain Score on Average (BPI - Short Form)(3 months postpartum)
- Perceived Stress (PSS)(2 days postpartum)
- Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)(2 Days Postpartum)
- Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)(6 weeks postpartum)
- Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)(3 months postpartum)
- Parent-Infant Attachment (MPAS)(3 months postpartum)
- Child Development (ASQ-3) Personal Social Score(3 months postpartum)
- Parenting Self-efficacy (PMP-SE)(6 weeks postpartum)
- Parenting Self-Efficacy (PMP-SE)(3 months postpartum)
- Edinburgh Postnatal Depression Score (EPDS)(3 months)
研究者
Grace Lim, MD, MS
Assistant Professor of Anesthesiology
University of Pittsburgh