Adverse Maternal and Neonatal OutcomesNCT00381056
The Labor and Delivery Teamwork Intervention Trial
A study testing Labor and Delivery Team Coordination Course in people with Adverse Maternal and Neonatal Outcomes, run by Beth Israel Deaconess Medical Center at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Adverse Maternal and Neonatal Outcomes
- What is being tested?
- Labor and Delivery Team Coordination Course
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30,000 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2000to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- delivery at a participating hospital between 12/31/02-03/31/04
- pregnancy of 20-43 weeks gestation
Who cannot join
- delivery at less than 20 weeks or greater than 43 weeks
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan
Ann Arbor, Michigan
Johns Hopkins Hospital
Baltimore, Maryland
National Naval Medical Center Bethesda
Bethesda, Maryland
University of Alabama
Birmingham, Alabama
University of Vermont
Burlington, Vermont
Tripler Army Medical Center
Honolulu, Hawaii
Baptist Health South Florda
Miami, Florida
University of Miami
Miami, Florida
Naval Hospital Campe Pendleton
Oceanside, California
Naval Medical Center Portsmouth
Portsmouth, Virginia
Beaumont Hospital
Royal Oaks, Michigan
Naval Medical Center San Diego
San Diego, California
Baystate Hospital
Springfield, Massachusetts
Madigan Army Medical Center
Tacoma, Washington, 98431
South Shore Hospital
Weymouth, Massachusetts
About this study
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.
Read the detailed 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.
- Conditions
- Adverse Maternal and Neonatal Outcomes
- Being tested
- Labor and Delivery Team Coordination Course
- Keywords
- labor and delivery care, teamwork training, crew resource management, cluster-randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor and Delivery Team Coordination CourseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startJul 2000
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Maternal and Neonatal OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,000 participants
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dynamics Research Corporation, Armed Forces Institute of Pathology, TRICARE Management Activity, Harvard Risk Management Foundation
- Investigators
- Benjamin P Sachs, MB, BS, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381056
- Sponsor's protocol ID
- 2002-P-000044
- Other IDs
- DAMD171-C-0052
- Status last verified
- Sep 2006
- First submitted
- 26 Sep 2006
- Last updated
- 27 Sep 2006
- Results posted
- No
Publications
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.
PubMed 17197587
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Labor and Delivery Teamwork Intervention Trial
- ClinicalTrials.gov ID
- NCT00381056
- Acronym / sponsor ID
- 2002-P-000044
- Conditions
- Adverse Maternal and Neonatal Outcomes
- Keywords
- labor and delivery care, teamwork training, crew resource management, cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dynamics Research Corporation, Armed Forces Institute of Pathology, TRICARE Management Activity, Harvard Risk Management Foundation
- Study start
- Jul 2000
- Study completion
- Mar 2004
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- delivery at a participating hospital between 12/31/02-03/31/04
- pregnancy of 20-43 weeks gestation
Key exclusion criteria (1 listed)
- delivery at less than 20 weeks or greater than 43 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor and Delivery Team Coordination Course | Behavioural | – |
Primary outcome
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).
1 secondary outcome
Additional outcomes were eleven process measures that recorded length of care or delay to action.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2006.
- Derived from this study: PubMed 17197587Nielsen 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.
Related trials for Adverse Maternal and Neonatal Outcomes
RecruitingObservational study
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Maternal Complications, Pregnancy Complication
Not yet recruiting
Postnatal Debriefing After Adverse Obstetric Events
Stress Disorders, Post-Traumatic, Psychological Trauma
Not yet recruiting
The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health
Preterm Birth, Preeclampsia
Recruiting
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
Overweight or Obesity
RecruitingObservational study
Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)
Low Birth Weight Baby, Small for Gestational Age (SGA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin P Sachs, MB, BS principal investigator
Beth Israel Deaconess Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labor and Delivery Team Coordination Course in people with Adverse Maternal and Neonatal Outcomes, run by Beth Israel Deaconess Medical Center at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2006.