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临床试验/NCT04504682
NCT04504682终止不适用

Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women

University of Chicago2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
2
主要终点
Cesarean Delivery Rate

研究概览

简要总结

The purpose of this study is to determine if ambulation with a labor epidural in place is associated with decreased rate of cesarean delivery in obese patients.

详细描述

Obese women are known to have increased risk of cesarean delivery and prolonged labors. Low concentration epidural analgesia can achieve pain relief and allow for ambulation. Prior investigations have not shown a benefit in cesarean delivery between those who ambulate with an epidural and those who do not. These studies were conducted in women with normal weights. It is unknown if ambulation with a labor epidural is beneficial in decreasing cesarean delivery among obese women.

Obese women at term with a singleton pregnancy will be enrolled in this pilot study. Patients will receive their epidural analgesia when they desire per standard protocol at our institution. Following epidural placement, a Modified Bromage Score and straight leg test will be performed. If the patient passes the straight leg test and has a modified Bromage score > 6, they will be allowed to ambulate. They will be encouraged to ambulate for 20 minutes per hour with another adult alongside them. Obstetric care will be standard of care.

On postpartum day one, the patient will be administered a Labor Agentry Scale. Chart review will then be conducted to review maternal and neonatal outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The person completing analysis will be blinded to the treatment group.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Subjects capable of giving consent Singleton pregnancy Nulliparous (defined as no previous pregnancy beyond 20 weeks 0 days) Gestational age greater than or equal to 37 weeks BMI > = 35 at time of delivery admission Adult companion available Anticipated vaginal delivery

排除标准

  • Physical disability precluding ambulation Magnesium Administration Contraindications to neuraxial analgesia Cerclage in current pregnancy Active labor DPE Category III fetal heart tracing Fetal Demise In Utero

结局指标

主要结局

Cesarean Delivery Rate

时间窗: At time of delivery

Percent of cesarean delivery

次要结局

  • First Stage Duration(From onset of labor until complete dilation)
  • Labor Duration(From labor onset to time of delivery)
  • Second Stage Duration(From complete dilation until delivery)
  • Perceived Labor Control(Within 4 days postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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