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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461704
• Other study ID #: NSD-TW-01
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: September 2020
• Source: CJshine Technology Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Female at least 20 years of age.

2. Have a course of labor that is > 4 hours.

3. American Society of Anesthesiologists Physical Status (ASA PS) Classification of Class I-II.

4. Clinical records of the subject are complete in the opinion of the investigator.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Labor Pain

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
CJshine Technology Company Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detect the association between labor pain and related physical parameters during labor progression	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.	Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby