Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
研究概览
简要总结
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.
Epidural analgesia is commonly performed after the parturient feels labor pain.
We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.
详细描述
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.
Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.
Parturients will be divided into two groups:
- Group I- those who have painless contractions awaiting augmentation of labor.
- Group II- parturients with cervical dilatation and painful labor (VAS >5).
Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy with no known fetal malformations
- •Above or equal to 38 weeks of pregnancy
排除标准
- •Systemic medical illnesses
- •Chronic medications except for iron and vitamins
- •Women developing fever > 380C
- •Women with history of delivery of children with cerebral palsy
- •History of infertility
- •Premature contractions
研究组 & 干预措施
Preemptive epidural analgesia
Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3).
干预措施: Preemptive epidural analgesia (Procedure)
Standard of care
Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible
干预措施: Standard of care (Drug)
结局指标
主要结局
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
时间窗: Right after enrollment
Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment
Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery
时间窗: 24 hours after delivery
Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth
时间窗: At birth of parturients
Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery
次要结局
未报告次要终点