To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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 Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator.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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Subject has any condition, which in the opinion of the investigator precludes the subject's participation in the study.

Treatment and study plan

Primary outcomes

To detect the association between labor pain and related physical parameters during labor progression

Time frame: 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.

Sponsors and collaborators

Lead sponsor

CJshine Technology Company Ltd.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 8, 2020
Registry last updated: Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed