NCT03018119

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 3, 2017

Last Update Submit

January 10, 2017

Conditions

Pregnancy HemorrhagePostpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented

    4 weeks

Secondary Outcomes (3)

  • Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components

    4 weeks

  • Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components

    6 months

  • Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care

    6 months

Study Arms (4)

Anesthesiologists

ACTIVE COMPARATOR

Total: 11 Intervention: Survey

Other: Survey

Obstetricians

ACTIVE COMPARATOR

Total: 11 Intervention: Survey

Other: Survey

Registered Nurses

ACTIVE COMPARATOR

Total: 10 Intervention: Survey

Other: Survey

Surgical Technicians

ACTIVE COMPARATOR

Total: 6 Intervention: Survey

Other: Survey

Interventions

SurveyOTHER
AnesthesiologistsObstetriciansRegistered NursesSurgical Technicians

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869.

    PMID: 26091046BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michaela Farber, MD, MS

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow - Obstetric Anesthesia

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 11, 2017

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)