Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 5:00 PM
Study NCT ID:
NCT05556304
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2022-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, longitudinal and single-center study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum value of equivalent deformation obtained by stereovision camera', 'timeFrame': 'delivery', 'description': 'maximum value of equivalent deformation obtained by stereovision camera'}], 'secondaryOutcomes': [{'measure': 'Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB', 'timeFrame': 'pregnancy', 'description': 'Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB'}, {'measure': 'Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB', 'timeFrame': 'delivery', 'description': 'elta between the minimum and maximum width of GH, and between the maximum and minimum length of PB'}, {'measure': 'Correlation between perineal deformation values and perineal tears', 'timeFrame': 'delivery', 'description': 'Correlation between perineal deformation values and perineal tears'}, {'measure': 'Correlation between perineal deformation values and fetal parameters', 'timeFrame': 'pregnancy', 'description': 'Correlation between perineal deformation values and fetal parameters'}, {'measure': 'Correlation between perineal deformation values and fetal parameters', 'timeFrame': 'delivery', 'description': 'Correlation between perineal deformation values and fetal parameters'}, {'measure': 'Correlation between fetal ultrasound and neonatal parameters and perineal tears', 'timeFrame': 'delivery', 'description': 'Correlation between fetal ultrasound and neonatal parameters and perineal tears'}, {'measure': 'Evolution of the elasticity of the perineal body and the SAE during delivery', 'timeFrame': 'delivery', 'description': 'Evolution of the elasticity of the perineal body and the SAE during delivery'}, {'measure': 'Correlation between elasticity of the perineal body and perineal tears', 'timeFrame': 'pregnancy', 'description': 'Correlation between elasticity of the perineal body and perineal tears'}, {'measure': 'Correlation between elasticity of the perineal body and perineal tears', 'timeFrame': 'delivery', 'description': 'Correlation between elasticity of the perineal body and perineal tears'}, {'measure': 'Correlation between the elasticity of the external anal sphincter and perineal tears', 'timeFrame': 'pregnancy', 'description': 'Correlation between the elasticity of the external anal sphincter and perineal tears'}, {'measure': 'Correlation between the elasticity of the external anal sphincter and perineal tears', 'timeFrame': 'delivery', 'description': 'Correlation between the elasticity of the external anal sphincter and perineal tears'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perineal tear', 'hyperelasticity'], 'conditions': ['Perineum; Rupture', 'Perineum; Tear', 'Perineal Tear']}, 'referencesModule': {'references': [{'pmid': '40107173', 'type': 'DERIVED', 'citation': 'Lallemant M, Kadiake T, Lejeune A, Cosson M, Chambert J, Jacquet E, Mottet N. Perineal body and anal sphincter biometrics and stiffness using elastography during labor: a feasibility study. Eur J Obstet Gynecol Reprod Biol. 2025 May;309:48-54. doi: 10.1016/j.ejogrb.2025.03.034. Epub 2025 Mar 12.'}, {'pmid': '39805482', 'type': 'DERIVED', 'citation': 'Lallemant M, Kadiake T, Lejeune A, Cosson M, Chambert J, Jacquet E, Mottet N. Exploring the influence of perineal biometrics and stiffness measured by elastography during pregnancy on perineal tears : A pilot study. J Gynecol Obstet Hum Reprod. 2025 Mar;54(3):102904. doi: 10.1016/j.jogoh.2025.102904. Epub 2025 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.', 'detailedDescription': 'The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant and volunteer women \\>18 years old\n* Primiparous\n* With a singleton pregnancy\n* No objection from the subject and the spouse to participate in the study\n\nExclusion Criteria:\n\n* History of prior delivery or c-section\n* History of perineal troubles\n* BMI \\> à 35 mg/m²\n* History of chronic muscular disease or connective tissue pathology\n* Psychiatric pathology requiring hospitalization\n* Patients who do not understand the French language\n* Legal incapacity or limited legal capacity\n* Patients unlikely to cooperate'}, 'identificationModule': {'nctId': 'NCT05556304', 'acronym': 'MecaPer', 'briefTitle': 'In Vivo Evaluation of Perineal Mechanical Properties During Childbirth', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'In Vivo Evaluation of Perineal Mechanical Properties During Childbirth', 'orgStudyIdInfo': {'id': '2022/694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'assessment in the 8th month of pregnancy and during delivery', 'description': 'The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth', 'interventionNames': ['Other: assessment in the 8th month of pregnancy and during delivery']}], 'interventions': [{'name': 'assessment in the 8th month of pregnancy and during delivery', 'type': 'OTHER', 'description': '* Day 0: presentation of the study\n* During pregnancy between Day 0 and 36-38SA: inclusion\n* During pregnancy: collection of pelvic MRI data if performed during pregnancy for maternal or fetal reasons\n* Between 36 and 38 WG: collection of demographic, obstetrical, fetal ultrasound and clinical data / Perineal elastographic recording / Recording of the perineal deformation by stereovision camera\n* In the delivery room, at the beginning of labor and before pushing: collection of clinical data / Collection of obstetrical ultrasound data / Perineal elastographic recordings / Recording of the perineal deformation by stereovision camera\n* In the delivery room, during expulsion : recording of the perineal deformation by stereovision camera\n* In the delivery room, after childbirth: collection of obstetrical, clinical and neonatal data / Perineal elastographic recordings / Cephalic and shoulder measurements of the newborn with a tape measure', 'armGroupLabels': ['assessment in the 8th month of pregnancy and during delivery']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}