The Labor and Delivery Teamwork Intervention Trial

Adverse Maternal and Neonatal Outcomes Clinical Trial

Official title:

The Labor and Delivery Teamwork Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381056
• Other study ID #: 2002-P-000044
• Secondary ID: DAMD171-C-0052
• Status: Completed
• Phase: N/A
• First received: September 26, 2006
• Last updated: September 26, 2006
• Start date: July 2000
• Est. completion date: March 2004

Study information

• Verified date: September 2006
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30000
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• delivery at a participating hospital between 12/31/02-03/31/04

• pregnancy of 20-43 weeks gestation

Exclusion Criteria:

• delivery at less than 20 weeks or greater than 43 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Adverse Maternal and Neonatal Outcomes

Intervention

Behavioral:
• Labor and Delivery Team Coordination Course

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	National Naval Medical Center Bethesda	Bethesda	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Baptist Health South Florda	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Naval Hospital Campe Pendleton	Oceanside	California
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Beaumont Hospital	Royal Oaks	Michigan
United States	Naval Medical Center San Diego	San Diego	California
United States	Baystate Hospital	Springfield	Massachusetts
United States	Madigan Army Medical Center	Tacoma	Washington
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Armed Forces Institute of Pathology, Dynamics Research Corporation, Harvard Risk Management Foundation, TRICARE Management Activity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	Additional outcomes were eleven process measures that recorded length of care or delay to action.