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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03018119
Other study ID # 2015P002403
Secondary ID
Status Completed
Phase N/A
First received January 3, 2017
Last updated January 10, 2017
Start date November 2015
Est. completion date April 2016

Study information

Verified date January 2017
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Survey


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Parternship for Maternal Safety.; Council for Patient Safety in Women's Health Care.. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-8. doi: 10.1097/AOG.0000000000000869. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented 4 weeks Yes
Secondary Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components 4 weeks No
Secondary Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components 6 months No
Secondary Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care 6 months No
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