- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018119
Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
January 10, 2017 updated by: Annemaria De Tina, Brigham and Women's Hospital
Implementation of the National Partnership for Maternal Safety Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method
The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage consensus bundle to provide every United States birthing facility consistent, validated practice guidelines.
To facilitate implementation of each element of this bundle at the participants large tertiary center, the investigators utilized the Delphi method to identify deficiencies, perceived barriers to implementation, and multidisciplinary consensus on changes with high feasibility and impact on patient care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ five years of experience on the L&D unit
- current employment on the L&D unit > 20h per week
- prior involvement in clinical obstetric hemorrhage situations
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Anesthesiologists
Total: 11 Intervention: Survey
|
|
|
Active Comparator: Obstetricians
Total: 11 Intervention: Survey
|
|
|
Active Comparator: Registered Nurses
Total: 10 Intervention: Survey
|
|
|
Active Comparator: Surgical Technicians
Total: 6 Intervention: Survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components
Time Frame: 4 weeks
|
4 weeks
|
|
Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components
Time Frame: 6 months
|
6 months
|
|
Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michaela Farber, MD, MS, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
January 3, 2017
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 11, 2017
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P002403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Hemorrhage
-
Dangana Zakari AdekaWest African College of Surgeons (WACS)CompletedPostpartum Hemorrhage (PPH) | Postpartum Hemorrhage Third Stage of Labour Retained PlacentaNigeria
-
University Hospital, Clermont-FerrandUnknownPostpartum Depression | Postpartum Hemorrhage | Postpartum Women | Postpartum Stress | Postpartum AnxietyFrance
-
ResQ Medical LtdRecruitingPPH | Postpartum Hemorrhage \(PPH\) | Postpartum Hemorrhage \(Primary\)Kenya
-
Cairo UniversityUnknownHemorrhage, PostpartumEgypt
-
Columbia UniversityCompletedHemorrhage, PostpartumUnited States
-
Ain Shams Maternity HospitalUnknownHemorrhage PostpartumEgypt
-
Chelsea and Westminster NHS Foundation TrustCompleted
-
Samuel Lunenfeld Research Institute, Mount Sinai...RecruitingPostpartum Hemorrhage (Primary)Canada
-
Megan LordThermaSENSE CorpCompletedHemorrhage | Vasoconstriction | Hemorrhage, PostpartumUnited States
-
Gynuity Health ProjectsAga Khan Health ServicesCompletedPostpartum Hemorrhage (PPH)Afghanistan
Clinical Trials on Survey
-
Johns Hopkins Bloomberg School of Public HealthPontificia Universidad JaverianaCompletedNoncommunicable Diseases | Surveys and QuestionnairesColombia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Université de Cergy PontoiseCompleted
-
Sarasota Memorial Health Care SystemEnrolling by invitation
-
Ohio State UniversityWithdrawnMedicare Part DUnited States
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health InstituteCompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania
-
Memorial Sloan Kettering Cancer CenterCompletedInpatients With Limited English ProficiencyUnited States
-
Lawson Health Research InstituteCompletedEvaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation ParticipationMyocardial Infarction | Unstable Angina | Coronary Angioplasty | Coronary Artery Bypass SurgeryCanada
-
University GhentCompletedStroke | Upper Extremity Paresis | Survey