To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To detect the association between labor pain and related physical parameters during labor progression
研究概览
简要总结
Analysis of monitored clinically parameters during the course of labor is a seldom studied area in Taiwan and worldwide. Important monitored parameters include, fetal heartbeat, uterine contractions, oxygen saturation and blood pressure, among others.1 During labor, uterine contractions can cause pain.3 This pain may be measured using a visual analogue scale (VAS).2 The pain from uterine contractions promotes the release of hormones including cortisol which can cause decreased or irregular contractions and possibly prolong labor.3 This study aims to study the association between monitored clinical parameters and pain in women in Taiwan during labor in order to increase the understanding to safe childbirth.
详细描述
This is a prospective, observational study to measure and collect and physical parameters from females at least 20 years of age in the labor room. Collection of measurements and physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2 will be recorded continuously until the end of the study period. In addition, uterus contraction cycle and fetal heart beat will be recorded during the study period based on standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at baseline and when the caregiver perceives that there is a change in the subject's pain status until the end of the study period. The time of each assessment of pain on VAS should be recorded. Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator. Subject participation in the study will end when eight hours have elapsed since baseline, the subject leaves the labor room or the subject delivers the baby.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 20 years of age.
- •Have a course of labor that is > 4 hours.
- •American Society of Anesthesiologists Physical Status (ASA PS) Classification of Class I-II.
- •Clinical records of the subject are complete in the opinion of the investigator.
排除标准
- •Subject has any condition, which in the opinion of the investigator precludes the subject's participation in the study.
结局指标
主要结局
To detect the association between labor pain and related physical parameters during labor progression
时间窗: Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby
Collection of measurements and physical parameters will begin when the subject enrolls in the study. Besides, ECG and SpO2 will be recorded continuously until the end of the study period. In addition, uterus contraction cycle and fetal heart beat will be recorded during the study period based on standard of care in the labor room. Pain will be recorded on a visual analogue scale (VAS) at baseline and when the caregiver perceives that there is a change in the subject's pain status until the end of the study period. The time of each assessment of pain on VAS should be recorded. Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator. Subject participation in the study will end when eight hours have elapsed since baseline, the subject leaves the labor room or the subject delivers the baby.
次要结局
未报告次要终点