Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00381056
Status:
COMPLETED
Last Update Posted:
2006-09-27
First Post:
2006-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Labor and Delivery Teamwork Intervention Trial
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': 'ECT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2004-03'}, 'lastUpdateSubmitDate': '2006-09-26', 'studyFirstSubmitDate': '2006-09-26', 'studyFirstSubmitQcDate': '2006-09-26', 'lastUpdatePostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).'}], 'secondaryOutcomes': [{'measure': 'Additional outcomes were eleven process measures that recorded length of care or delay to action.'}]}, 'conditionsModule': {'keywords': ['labor and delivery care', 'teamwork training', 'crew resource management', 'cluster-randomized trial'], 'conditions': ['Adverse Maternal and Neonatal Outcomes']}, 'referencesModule': {'references': [{'pmid': '17197587', 'type': 'DERIVED', 'citation': 'Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, Greenberg P, McNamee P, Salisbury M, Birnbach DJ, Gluck PA, Pearlman MD, King H, Tornberg DN, Sachs BP. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):48-55. doi: 10.1097/01.AOG.0000250900.53126.c2.'}]}, 'descriptionModule': {'briefSummary': 'A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.', 'detailedDescription': 'A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery. The intervention, called the Labor \\& Delivery Team Coordination Course, was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index, AOI). Additional outcomes included 11 clinical process measures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* delivery at a participating hospital between 12/31/02-03/31/04\n* pregnancy of 20-43 weeks gestation\n\nExclusion Criteria:\n\n* delivery at less than 20 weeks or greater than 43 weeks'}, 'identificationModule': {'nctId': 'NCT00381056', 'briefTitle': 'The Labor and Delivery Teamwork Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'The Labor and Delivery Teamwork Intervention Trial', 'orgStudyIdInfo': {'id': '2002-P-000044'}, 'secondaryIdInfos': [{'id': 'DAMD171-C-0052'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Labor and Delivery Team Coordination Course', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Naval Hospital Campe Pendleton', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health South Florda', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Naval Medical Center Bethesda', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Hospital', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Weymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'South Shore Hospital', 'geoPoint': {'lat': 42.22093, 'lon': -70.93977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Royal Oaks', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital'}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Benjamin P Sachs, MB, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dynamics Research Corporation', 'class': 'INDUSTRY'}, {'name': 'Armed Forces Institute of Pathology', 'class': 'FED'}, {'name': 'TRICARE Management Activity', 'class': 'UNKNOWN'}, {'name': 'Harvard Risk Management Foundation', 'class': 'OTHER'}]}}}