Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT05096104
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective study of the cervical ripening method that patients choose when artificial induction of labor with unfavorable cervical status must be performed', 'timeFrame': 'Files analysed retrospectively from JFebruary 01, 2020 to February 29, 2021 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Ripening', 'PREGNANCY', 'LABOR INDUCED', 'Artificial induction'], 'conditions': ['Cervical Ripening']}, 'descriptionModule': {'briefSummary': "20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians.\n\nThe objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult woman who underwent induction of labor between February 1, 2020 and February 29, 2021', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult woman (≥18 years old)\n* Patient who underwent induction of labor between February 1, 2020 and February 29, 2021\n* Patient not having expressed her opposition, after information, to the reuse of her data for the purposes of this research.\n\nExclusion Criteria:\n\n* Patient who expressed her opposition to participating in the study\n* Absence of prior cervical maturation (Bishop score greater than or equal to 6 on the day of initiation)\n* Gestational age less than 37 weeks, multiple pregnancy, scarred uterus, non-cephalic presentation, death in utero and severe fetal malformation (requiring neonatal resuscitation or with a palliative care plan)\n* Patient for whom the triggering method was chosen by the practitioner\n* Patient under guardianship, curatorship or safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05096104', 'acronym': 'CERVICAL', 'briefTitle': 'Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening', 'orgStudyIdInfo': {'id': '8294'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Nicolas SANANES, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}