Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00711451
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015870', 'term': 'Gene Expression'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'unable to recruit patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic profile, especially Systemic Vascular Resistance', 'timeFrame': 'immediately before and 24 hours after cesarean delivery'}], 'secondaryOutcomes': [{'measure': 'development of postpartum preeclampsia', 'timeFrame': 'within 1 week of delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['systemic vascular resistance', 'pregnancy', 'scheduled cesarean delivery', 'syncytiotrophoblast apoptosis', 'continuous wave Doppler'], 'conditions': ['Pregnancy', 'Cesarean Delivery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR)', 'detailedDescription': 'Patients presenting to William Beaumont Hospital Royal Oak Labor and Delivery for a scheduled low transverse cesarean delivery will be asked to participate in a prospective, randomized study to evaluate any changes in systemic vascular resistance (SVR) pre- and post-delivery.\n\nAfter obtaining informed consent, the patients will be randomized to one of two groups: group 1 will have manual removal of the placenta at cesarean section and group 2 will have expressed removal of the placenta at cesarean section.\n\nBoth groups will have a pre-operative continuous wave Doppler evaluation and a post-operative continuous wave Doppler evaluation at 24 hours after delivery. Continuous wave Doppler evaluation will be used pre- and post-operatively to evaluate any changes in SVR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant\n* scheduled for cesarean delivery\n* able to give informed consent\n\nExclusion Criteria:\n\n* taking medications that may affect hemodynamics\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00711451', 'briefTitle': 'Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Manual and Expressed Placental Removal at Planned Cesarean Delivery and Its Effects on Various Cardiac Indices as Measured By Continuous Wave Doppler Ultrasonography', 'orgStudyIdInfo': {'id': '2008-056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'manual', 'description': 'Manual removal of placenta', 'interventionNames': ['Behavioral: Manual removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'expressed', 'description': 'expressed placental removal', 'interventionNames': ['Procedure: Expressed removal']}], 'interventions': [{'name': 'Manual removal', 'type': 'BEHAVIORAL', 'otherNames': ['manual'], 'description': 'Manual removal of placenta during cesarean delivery', 'armGroupLabels': ['manual']}, {'name': 'Expressed removal', 'type': 'PROCEDURE', 'otherNames': ['expressed'], 'description': 'Surgeon will perform an expressed delivery of the placenta', 'armGroupLabels': ['expressed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Christian Bogner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'John Uckele', 'investigatorAffiliation': 'Corewell Health East'}}}}