Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-17 @ 4:37 PM
Study NCT ID:
NCT04169035
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of births successfully assisted with the BD Odon Device', 'timeFrame': '3 months after delivery', 'description': 'Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnant Woman']}, 'referencesModule': {'references': [{'pmid': '38462265', 'type': 'DERIVED', 'citation': 'Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The woman is ≥18 years of age\n* The woman has a singleton pregnancy\n* The pregnancy is ≥28+0 weeks' gestation\n* There is a negative antenatal screen for HIV and Hepatitis B\n\nExclusion Criteria:\n\n* The woman does not fulfil all of the inclusion criteria listed\n* There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)\n* There is a known osteogenesis imperfecta affected pregnancy\n* There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)\n* There is an intrauterine fetal death in the current pregnancy\n* The woman is sensitive to latex\n* The woman is currently serving a prison sentence\n* The woman lacks capacity to consent\n* The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires\n* The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours\n* The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place"}, 'identificationModule': {'nctId': 'NCT04169035', 'acronym': 'ASSIST', 'briefTitle': 'The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy', 'orgStudyIdInfo': {'id': 'P/2019/435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Odon device', 'description': "The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assiste vaginal birth. Odon trained practitioner available to assist the birth.", 'interventionNames': ['Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Forceps or ventouse', 'description': "The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assisted vaginal birth.\n\nThe woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth.", 'interventionNames': ['Procedure: forceps or ventouse']}], 'interventions': [{'name': 'The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.', 'type': 'DEVICE', 'description': "The BD Odon DeviceTM works by placing a cuff of air attached to a plastic sleeve, around the baby's head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.", 'armGroupLabels': ['Odon device']}, {'name': 'forceps or ventouse', 'type': 'PROCEDURE', 'description': "The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth.\n\nForceps is a metal instrument with two handles used to encircle a baby's head and assist in birth.\n\nVentouse is a device used to help a baby be born by putting it over the baby's head and using suction (= removing air) to pull the baby out of the mother's body.", 'armGroupLabels': ['Forceps or ventouse']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louis BENAZET', 'role': 'CONTACT'}, {'name': 'Nicolas Mottet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Louis BENAZET', 'role': 'CONTACT', 'email': 'lbenazet@chu-besancon.fr', 'phone': '+33 381 219 147'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}