- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461704
To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women
September 30, 2020 updated by: CJshine Technology Company Ltd.
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.
Study Overview
Status
Completed
Conditions
Detailed 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Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator.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.
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Maternity at least 20 years of age in the labor room
Description
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:
1. Subject has any condition, which in the opinion of the investigator precludes the subject's participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2020
Primary Completion (Actual)
August 10, 2020
Study Completion (Actual)
August 10, 2020
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 2, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
October 1, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSD-TW-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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