Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT02941393
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal Versus External Tocodynamometry and Labor Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004420', 'term': 'Dystocia'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cesarean sections', 'timeFrame': 'through study completion, an average of 6 years'}, {'measure': 'Number of operative vaginal deliveries', 'timeFrame': 'through study completion, an average of 6 years'}], 'secondaryOutcomes': [{'measure': 'Duration of labor', 'timeFrame': 'From time of first regular contraction to birth'}, {'measure': 'Newborn admission to the pediatric care unit', 'timeFrame': '3 days after birth'}, {'measure': 'The use of Oxytocin during labor', 'timeFrame': 'From beginning of the use of oxytocin to the birth'}, {'measure': 'Apgar scores', 'timeFrame': '10 min after birth'}, {'measure': 'Ph of umbilical artery', 'timeFrame': 'immediately after birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia'], 'conditions': ['Dystocia', 'Contractions']}, 'descriptionModule': {'briefSummary': "In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age ≥ 37 weeks\n* singleton pregnancy\n* a fetus in cephalic position\n* normal cardiotocograph in the time of randomization\n* cervical ripening \\< 7 cm\n* either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section\n\nExclusion Criteria:\n\n* parturient with hepatitis or HIV or other significant viral infection\n* Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization\n* Estimated fetal weight over 4,5 kg\n* Suspected fetal abnormality'}, 'identificationModule': {'nctId': 'NCT02941393', 'briefTitle': 'Internal Versus External Tocodynamometry and Labor Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn', 'orgStudyIdInfo': {'id': 'R12229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intrauterine pressure catheter', 'description': 'Intrauterine pressure catheter is used during labor to follow up the contractions', 'interventionNames': ['Device: Intrauterine pressure catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External tocodynamometry', 'description': 'External tocodynamometry is used during labor to follow up the contractions', 'interventionNames': ['Device: External tocodynamometry']}], 'interventions': [{'name': 'Intrauterine pressure catheter', 'type': 'DEVICE', 'otherNames': ['Internal tocodynamometry'], 'armGroupLabels': ['Intrauterine pressure catheter']}, {'name': 'External tocodynamometry', 'type': 'DEVICE', 'armGroupLabels': ['External tocodynamometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40640', 'city': 'Jyväskylä', 'state': 'Central Finland', 'country': 'Finland', 'facility': 'Cetral Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '33520', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Tuija Hautakangas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Finland Central Hospital, Tampere University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Finland Hospital District', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Tuija Hautakangas', 'investigatorAffiliation': 'Tampere University Hospital'}}}}