Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 10:57 PM
Study NCT ID:
NCT05707650
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2023-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-22', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-01-22', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine incision extension', 'timeFrame': 'intra-operative', 'description': 'uterine extensions will include angle extensions on lower segments and into the broad ligaments".'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructed Labor at Second Stage of Labor']}, 'descriptionModule': {'briefSummary': 'Management of impacted fetal head during second stage cesarean requires careful and gentle attention to various surgical steps for delivery of a fetus without adverse maternal and neonatal outcomes, mostly by an experienced surgeon as in such situations, the lower uterine segment may be over-distended and indistinguishable from the vagina. Therefore, the uterine incision may inadvertently be placed too low, or in the vagina.\n\nAlso, it may be difficult for the operating surgeon to maneuver his hand below the deeply engaged fetal head, which may be further compounded by the presence of molding and edema on the fetal head (caput succedaneum).\n\nThis prospective controlled study was conducted at labor ward of department of obstetrics and gynecology at Ain Shams University Maternity Hospital to compare between the two techniques. A total of 70 pregnant women were enrolled and divided into two equal groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Singleton pregnancies.\n\n * Cephalic presentation will undergo cesarean section in advanced labor with the fetal head deeply engaged in the pelvis defined as fully dilated cervix and vertex at or below zero station\n\nExclusion Criteria:\n\n* • Twins Pregnancies.\n\n * Breech or transverse presentation.\n * Woman has other obstetric indication to cs ex, fetal distress.\n * Woman has risk factor for bleeding ex, bleeding disorders'}, 'identificationModule': {'nctId': 'NCT05707650', 'briefTitle': 'Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Reverse Breech Extraction Versus Push Technique for Fetal Delivery When Fetal Head is Deeply Impacted in the Pelvis During CS on A Fully Dilated Cervix', 'orgStudyIdInfo': {'id': 'FMASU MS492/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Women allocated to this group will deliver by using reverse breech extraction technique.', 'interventionNames': ['Procedure: reverse breech extraction technique or push technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Women allocated to this group will deliver by using Push technique.', 'interventionNames': ['Procedure: reverse breech extraction technique or push technique']}], 'interventions': [{'name': 'reverse breech extraction technique or push technique', 'type': 'PROCEDURE', 'description': 'using reverse breech extraction technique or push technique for disimpaction of fetal head during cs of a fully dilated cervix', 'armGroupLabels': ['Women allocated to this group will deliver by using Push technique.', 'Women allocated to this group will deliver by using reverse breech extraction technique.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ebtihal ahmed, baccalarous', 'role': 'CONTACT', 'email': 'betoooo_b2@yahoo.com', 'phone': '01062477324'}], 'facility': 'Faculty of Medecine At Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ebtihal ahmed, baccalaureus', 'role': 'CONTACT', 'email': 'betoooo_b2@yahoo.com', 'phone': '01062477324'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ebtihal Ahmed', 'investigatorAffiliation': 'Ain Shams University'}}}}