NCT00381056

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

September 27, 2006

Status Verified

September 1, 2006

First QC Date

September 26, 2006

Last Update Submit

September 26, 2006

Conditions

Keywords

labor and delivery careteamwork trainingcrew resource managementcluster-randomized trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Additional outcomes were eleven process measures that recorded length of care or delay to action.

Interventions

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • delivery at a participating hospital between 12/31/02-03/31/04
  • pregnancy of 20-43 weeks gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Alabama

Birmingham, Alabama, United States

Location

Naval Hospital Campe Pendleton

Oceanside, California, United States

Location

Naval Medical Center San Diego

San Diego, California, United States

Location

Baptist Health South Florda

Miami, Florida, United States

Location

University of Miami

Miami, Florida, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, United States

Location

National Naval Medical Center Bethesda

Bethesda, Maryland, United States

Location

Baystate Hospital

Springfield, Massachusetts, United States

Location

South Shore Hospital

Weymouth, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Beaumont Hospital

Royal Oaks, Michigan, United States

Location

University of Vermont

Burlington, Vermont, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Benjamin P Sachs, MB, BS

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Study Start

July 1, 2000

Study Completion

March 1, 2004

Last Updated

September 27, 2006

Record last verified: 2006-09

Locations