Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
Study NCT ID:
NCT07258459
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012449', 'term': 'Safety'}], 'ancestors': [{'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2016}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vaginal birth after 2 cesarean', 'timeFrame': '5 years', 'description': 'Incidence of patients having a vaginal birth after 2 CS'}, {'measure': 'accepted indication to trial of labor', 'timeFrame': '5 years', 'description': 'incidence of women accepting indication to trial of labor'}], 'secondaryOutcomes': [{'measure': 'emergency CS', 'timeFrame': '5 years', 'description': 'incidence of emergency CS'}, {'measure': 'maternal outcomes', 'timeFrame': '5 years', 'description': 'incidence of adverse maternal outcomes (PPH, blood transfusion, vaginal tears, hysterectomy)'}, {'measure': 'Fetal and Neonatal adverse outcomes', 'timeFrame': '5 years', 'description': "Incidence of fetal/neonatal death, NICU stay, APGAR score below 7 at 5'"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['previous CS', 'trial of labor', 'maternal outcomes', 'fetal outcomes', 'neonatal outcomes'], 'conditions': ['Cesarean Delivery Affecting Fetus or Newborn', 'Labor (Obstetrics)--Complications', 'Hemorrhagic Complications']}, 'referencesModule': {'references': [{'pmid': '40771829', 'type': 'RESULT', 'citation': 'Brandstetter M, Brandstetter A, Kainz-Schultes S, Jacobs VR, Fazelnia C, Fischer T, Bogner G. Successful Trial of Labor After Two Caesarean Sections (TOLA2C): Analysis of a Delivery Protocol with Feto-Maternal Outcome. Geburtshilfe Frauenheilkd. 2025 Feb 7;85(8):862-869. doi: 10.1055/a-2513-6562. eCollection 2025 Aug.'}]}, 'descriptionModule': {'briefSummary': "In 2015 ObGyn Dept of Santo Spirito Hospital in Pescara (Italy) started protocol for previous CS vaginal birth. In 2021 was started a protocol for training on obstetric emergencies and protocol on two previous cesarean was endorsed. Patients attending birth in Pescara with two previous from january 2016 to December 2020, and from january 2021 to december 2025 were collected. A different counseling approach was adopted from 2021. Women's acceptance of trial of labor and maternal and fetal outcomes were collected.", 'detailedDescription': "Women attending birth in Santo Spirito Hospital with 2 previous CS were collected.\n\nExclusion Criteria:\n\n* Patients with clinical indication to CS\n* a previous CS less than 18 month before\n* breech presentations\n* triplets\n* premature labor before 34 completed weeks' gestation The first period was starting January 1st 2016 to December 31st 2020. The second period was starting January 1st 2021 to December 31st 2025\n\nPrimary outcomes:\n\n* incidence of trial of labor acceptance\n* incidence of vaginal birth\n\nSecondary outcomes:\n\n* maternal adverse outcomes (PPH, blood transfusion, vaginal tears, hysterectomy, maternal death)\n* fetal adverse outcomes (fetal death, NICU stay, APGAR score less than 7 at 5')"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women attending birth in Santo Spirito Hospital Pescara (Italy) from 01-01-2016 to 31-12-2025', 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* pregnant women\n* pregnancy above 34 weeks' gestation\n* cephalic presentation of the fetus\n* singleton and twins\n* diamniotic twins\n* 2 previous CS\n* more than 18 months from last CS\n* no other indication to CS\n\nExclusion Criteria:\n\n* pregnancy below 34 weeks' gestation\n* breech baby\n* triplets or high order multiple pregnancies\n* more than 2 previous CS\n* less than 18 months from last CS\n* precence of other indications to CS (i.e. maternal diseases, placenta previa, etc.)"}, 'identificationModule': {'nctId': 'NCT07258459', 'acronym': 'TOLA2C Train', 'briefTitle': 'Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Trial of Labor After Two CS Before and After Training a Protocol Introduction', 'orgStudyIdInfo': {'id': 'ObGynEASC009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 2', 'description': 'term pregnant women with 2 previous CS from 01.01.2021 to 31.12.2025', 'interventionNames': ['Procedure: Acceptance, rate of vaginal birth and safety']}, {'label': 'Group 1', 'description': 'Women with a history of two previous CS in period 01.01.2026 - 31-12.2020', 'interventionNames': ['Procedure: Acceptance, rate of vaginal birth and safety']}], 'interventions': [{'name': 'Acceptance, rate of vaginal birth and safety', 'type': 'PROCEDURE', 'description': 'In 2021 started a new delivery protocol enhancing the opportunity of having a trial of labor in women with a history of two previous CS. Rate of acceptance, rate of successful vaginal birth, maternal and fetal outcomes were evaluated', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Pescara', 'state': 'PE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Celentano, MD', 'role': 'CONTACT', 'email': 'celentanoclaudio70@gmail.com', 'phone': '+393285577305'}], 'facility': 'Claudio Celentano', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '65123', 'city': 'Pescara', 'state': 'PE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio Rosati, MD', 'role': 'CONTACT', 'email': 'claudio.celentano@ausl.pe.it', 'phone': '+39 085 4252247'}], 'facility': 'Santo Spirito Hospital', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}], 'centralContacts': [{'name': 'Claudio Celentano, MD', 'role': 'CONTACT', 'email': 'celentanoclaudio70@gmail.com', 'phone': '+39 328 5577305'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Claudio Celentano', 'investigatorAffiliation': "G. d'Annunzio University"}}}}