Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia: A Single-center Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ObsQoR-10 scores of postpartum patients
研究概览
简要总结
The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system.
详细描述
In this study, we planned to conduct a study to compare the postpartum recovery of pregnant women according to patient-reported outcome measures using the ObsQoR-10 score in vaginal deliveries with and without neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia).
In this study, after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and written informed consent of the patients, 40 pregnant women who will deliver vaginally with or without neuraxial analgesia will be prospectively enrolled.
Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group A and Group B. Pregnant women in Group A will receive neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia), while Group B will not. If postpartum analgesic needs arise, patients in Group A will receive 0.0625% bupivacaine via epidural route, while pregnant women in Group B will receive iboprufen and acetaminophen if needed.
ObsQoR-10 scores of the postpartum patients will be evaluated and recorded at discharge. In addition, basic demographic information and medical, analgesic and obstetric parameters related to the peripartum period will be recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being ≥18 years old
- •Pregnant women consenting to neuraxial analgesia for labor
- •Being ≥37 weeks gestation
排除标准
- •Patients in whom neuraxial analgesia is contraindicated
- •Being <18 years old
- •Being <37 weeks gestation
研究组 & 干预措施
Group A
Pregnant women in Group A will receive neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia).
If postpartum analgesic needs arise, patients in Group A will receive 0.0625% bupivacaine via epidural route.
干预措施: labor with neuraxial labor analgesia (Procedure)
Group B
Pregnant women in Group A will not receive neuraxial labor analgesia. If postpartum analgesic needs arise, patients in Group B will receive iboprufen and acetaminophen if needed.
干预措施: labour without noroaxial labor analgesia (Procedure)
结局指标
主要结局
ObsQoR-10 scores of postpartum patients
时间窗: Patients' ObsQoR-10 scores will be determined at 24 hours postpartum
ObsQoR-10 scores of postpartum patients will be recorded before discharge
次要结局
未报告次要终点
研究者
Aysenur Dostbil
clinical professor
Ataturk University