Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT04461704
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect the association between labor pain and related physical parameters during labor progression', 'timeFrame': 'Eight hours have elapsed since baseline or the subject leaves the labor room or the subject delivers the baby', 'description': "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 Subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator.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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '39243100', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Maternity at least 20 years of age in the labor room', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female at least 20 years of age.\n2. Have a course of labor that is \\> 4 hours.\n3. American Society of Anesthesiologists Physical Status (ASA PS) Classification of Class I-II.\n4. Clinical records of the subject are complete in the opinion of the investigator.\n\nExclusion Criteria:\n\n1\\. Subject has any condition, which in the opinion of the investigator precludes the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT04461704', 'briefTitle': 'To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'CJshine Technology Company Ltd.'}, 'officialTitle': 'To Study the Association Among Labor Pain and Physical Parameters in Laboring Pregnant Women', 'orgStudyIdInfo': {'id': 'NSD-TW-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CJshine Technology Company Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}