Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 12:40 AM
Study NCT ID:
NCT06502418
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture to Managed Pain During Induced Labor with Cook's Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of 7 acupuncture points on pain', 'timeFrame': 'Day 1', 'description': "Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon"}], 'secondaryOutcomes': [{'measure': 'Evaluate the consumption of analgesics between the 2 groups', 'timeFrame': 'Day 1', 'description': 'datas of analgesics consumption will be collected in patient record'}, {'measure': 'Evaluate experiences of the patient during labor induction between the 2 groups', 'timeFrame': 'Day 1', 'description': 'Use of questionnary'}, {'measure': 'Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups', 'timeFrame': 'Day 2', 'description': 'datas will be collected in patient record'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture therapy', 'Labor induction', 'Pain management'], 'conditions': ['Labor Induction']}, 'descriptionModule': {'briefSummary': "In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.\n\nAt Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.\n\nNo studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.", 'detailedDescription': "Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.\n\na questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.\n\nPatients will be randomised."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* pregnant woman with a gestational age of 37 weeks and above\n* age\\>=18 years old\n* having medical indication to be labor induced by Cook's Balloon\n* speaking French\n* agreeing to participate by signing informed consent form\n\nExclusion Criteria:\n\n* patient having contraindication for the use of Cook's balloon\n* patients under curatorship and/or guardianship"}, 'identificationModule': {'nctId': 'NCT06502418', 'acronym': 'COOKACUPAIN', 'briefTitle': "Acupuncture to Managed Pain During Induced Labor with Cook's Balloon", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Roubaix'}, 'officialTitle': "Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix", 'orgStudyIdInfo': {'id': '2023-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture arm', 'description': 'Acupuncture therapy', 'interventionNames': ['Other: Acupuncture therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'usual care'}], 'interventions': [{'name': 'Acupuncture therapy', 'type': 'OTHER', 'description': "7 acupuncture points will be used to managed pain and improved patient's experience", 'armGroupLabels': ['Acupuncture arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'facility': 'CH de Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Roubaix', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}