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

NCT04461704 | Completed

• 1 other identifier: NSD-TW-01
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

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 Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator.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

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Maternity at least 20 years of age in the labor room

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CJshine Technology Company Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chu YC, Chen SS, Chen KB, Sun JS, Shen TK, Chen LK. Enhanced labor pain monitoring using machine learning and ECG waveform analysis for uterine contraction-induced pain. BioData Min. 2024 Sep 7;17(1):32. doi: 10.1186/s13040-024-00383-z.

  PMID: 39243100 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: April 14, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

TW (1)