Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 10:05 AM
Study NCT ID:
NCT00224250
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Study of the Uterine Healing Process After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myometrial thickness'}]}, 'conditionsModule': {'conditions': ['Myometrial Remodeling']}, 'referencesModule': {'references': [{'pmid': '17906013', 'type': 'DERIVED', 'citation': 'Hamar BD, Saber SB, Cackovic M, Magloire LK, Pettker CM, Abdel-Razeq SS, Rosenberg VA, Buhimschi IA, Buhimschi CS. Ultrasound evaluation of the uterine scar after cesarean delivery: a randomized controlled trial of one- and two-layer closure. Obstet Gynecol. 2007 Oct;110(4):808-13. doi: 10.1097/01.AOG.0000284628.29796.80.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery.', 'detailedDescription': 'We are recruiting women who are presenting for their first (primary) cesarean delivery. They will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. Ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton gestation\n* term pregnancy\n* Kerr uterine incision employed\n* age \\> 18\n\nExclusion Criteria:\n\n* Pain score \\> 4\n* Current cesarean delivery for non-reassuring fetal status or other emergent situation (eg. maternal bleeding, etc.)\n* Prior cesarean section\n* Prior uterine surgery\n* Hysterotomy other than Kerr (low transverse) incision in current cesarean\n* Extension of the uterine incision in current cesarean\n* Multifetal pregnancy\n* Maternal diabetes mellitus\n* Maternal connective tissue disorder\n* Uterine malformation\n* Uterine myomas (fibroids) in the anterior lower uterine segment\n* Chorioamnionitis\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT00224250', 'briefTitle': 'Ultrasound Study of the Uterine Healing Process After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.', 'orgStudyIdInfo': {'id': '27269'}}, 'armsInterventionsModule': {'interventions': [{'name': 'One- versus two-layer hysterotomy closure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Benjamin Hamar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}}}}