Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-24 @ 3:23 AM
Study NCT ID:
NCT02264834
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2014-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deambulatory Epidural During the Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time between peridural application and childbirth', 'timeFrame': 'at delivery', 'description': 'This will be used to assess labor.'}, {'measure': 'Caesarian', 'timeFrame': 'at delivery', 'description': 'This will be used to assess labor. Was a caesarian necessary (yes-no) ?'}, {'measure': 'Instrumentalisation', 'timeFrame': 'at delivery', 'description': 'This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?'}, {'measure': 'Apgar score of the baby', 'timeFrame': 'at delivery', 'description': 'Evaluation of the baby, using the Apgar score. This will be used to assess labor.'}], 'secondaryOutcomes': [{'measure': 'Bromage score', 'timeFrame': '1h after the start of the peridural', 'description': 'Modified Bromage score (Breen et al) \\>5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity).'}, {'measure': 'Romberg test', 'timeFrame': '1h after the start of the peridural', 'description': 'Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).'}, {'measure': 'Arterial tension', 'timeFrame': '1h after the start of the peridural', 'description': 'Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epidural', 'primiparous patient', 'deambulation'], 'conditions': ['First Pregnancy']}, 'descriptionModule': {'briefSummary': 'Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.', 'detailedDescription': 'Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free written consent.\n* ASA I or II,\n* Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm\n* VAS\\> 30 mm\n* No contraindications to peridural\n\nExclusion Criteria:\n\n* Twin pregnancy, less than 36 weeks and 42 weeks\n* Fetus in breech position\n* Analgesia and sedation within 6h\n* Contraindications to peridural'}, 'identificationModule': {'nctId': 'NCT02264834', 'briefTitle': 'Deambulatory Epidural During the Labour', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Comparison of Two Different Peridural During the Labor and Effect of Deambulation', 'orgStudyIdInfo': {'id': 'PDB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL', 'interventionNames': ['Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml', 'Procedure: Lumbar epidural analgesia']}, {'type': 'EXPERIMENTAL', 'label': 'Ambulatory group', 'description': 'Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL', 'interventionNames': ['Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml', 'Procedure: Lumbar epidural analgesia']}], 'interventions': [{'name': 'Levobupivacaine 0.1% + Sufentanil 0.2µg/ml', 'type': 'DRUG', 'otherNames': ['control group'], 'description': 'Levobupivacaine 0.1% + Sufentanil 0.2µg/ml', 'armGroupLabels': ['Control group']}, {'name': 'Levobupivacaine 0.07% + Sufentanil 0.3µg/ml', 'type': 'DRUG', 'otherNames': ['ambulatory group'], 'description': 'Levobupivacaine 0.07% + Sufentanil 0.3µg/ml', 'armGroupLabels': ['Ambulatory group']}, {'name': 'Lumbar epidural analgesia', 'type': 'PROCEDURE', 'otherNames': ['labor analgesia'], 'description': 'Introduction of a catheter in lumbar epidural space', 'armGroupLabels': ['Ambulatory group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHUB', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Philippe Vanderlinden', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHUB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Madeleine Wilwerth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'primary investigator', 'investigatorFullName': 'Dr Madeleine Wilwerth', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}