Prescription After Cesarean Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,521
- 试验地点
- 12
- 主要终点
- Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
研究概览
简要总结
Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
详细描述
This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg. The primary endpoint was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women were assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization was stratified by site. Women were followed through 90 days postpartum.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
- •Singleton, twin or triplet gestation
排除标准
- •An opioid prescription filled during the current pregnancy
- •Known history of opioid use disorder, by medical record review
- •Contraindication to opioids (oxycodone)
- •Contraindications to both acetaminophen and ibuprofen
- •Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
- •Fetal or neonatal death prior to randomization
- •Inability to randomize within 1 day before planned discharge from the hospital
- •Inability to participate in shared decision making as assessed by research staff
- •Language barrier (non-English or Spanish speaking)
- •Participation in this trial in a previous pregnancy
- •Participation in another intervention study that influences the primary outcome in this trial
研究组 & 干预措施
Individualized Opioid Prescription
Individualized opioid prescription protocol and shared decision making
干预措施: 0 to 20 tablets of oxycodone 5mg (Drug)
Fixed Opioid Prescription
Fixed opioid prescription of 20 tablets of oxycodone 5mg
干预措施: Fixed opioid prescription (Drug)
结局指标
主要结局
Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
时间窗: 1 week post hospital discharge
Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.
次要结局
- Infant Hospital Readmissions(6 weeks postpartum)
- Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge(After hospital discharge and up to 90 days postpartum)
- Number of Opioid Prescriptions Filled(90 days postpartum)
- Number of Opioid Tablets Unused Since Discharge(90 days postpartum)
- Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge(2 weeks post discharge)
- Worst Pain Severity Score at 2 Weeks Post Discharge(2 weeks post discharge)
- Pain Interference Score ≥ 4 at 2 Weeks Post Discharge(2 weeks post discharge)
- Number of Participants Who Indicated an Improved Global Impression of Change(2 weeks post discharge)
- Maternal Depression Score ≥ 13(6 weeks postpartum)