Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT03439956
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cesarean sections', 'timeFrame': 'During the whole study period (2 years).', 'description': 'Percentage of cesarean sections'}], 'secondaryOutcomes': [{'measure': 'Operative deliveries', 'timeFrame': 'During the whole study period (2 years).', 'description': 'Percentage of operative deliveries'}, {'measure': 'Gestational age at deliveries', 'timeFrame': 'During the whole study period (2 years).', 'description': 'Gestational age at the moment of delivery.'}, {'measure': 'Pregnancy complications', 'timeFrame': 'During the whole study period (2 years).', 'description': 'Percentages of complications occurring during pregnancies.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstetric outcomes', 'Transvaginal specimen extraction', 'Gynecological laparoscopy'], 'conditions': ['Pregnancy Complications', 'Delivery;Abnormal;Stillbirth']}, 'descriptionModule': {'briefSummary': 'One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.\n\nAlthough recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.\n\nFor this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy\n\nExclusion Criteria:\n\n* Any pre-existent cause of high risk for adverse obstetric outcomes.'}, 'identificationModule': {'nctId': 'NCT03439956', 'acronym': 'OUTSET-1', 'briefTitle': 'Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy', 'orgStudyIdInfo': {'id': 'OUTSET-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transvaginal specimen extraction (cases)', 'description': 'Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.', 'interventionNames': ['Procedure: Transvaginal specimen extraction']}, {'label': 'Controls', 'description': 'Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.'}], 'interventions': [{'name': 'Transvaginal specimen extraction', 'type': 'PROCEDURE', 'description': 'Previous transvaginal specimen extraction through posterior colpotomy.', 'armGroupLabels': ['Transvaginal specimen extraction (cases)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'CONTACT', 'email': 'antoniosimone.lagana@asst-settelaghi.it', 'phone': '3296279579', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Antonio Simone Laganà, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}