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PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact (PRONTO)

Primary Purpose

Pregnancy Related Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRONTO training
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy Related Complications focused on measuring Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team, Simulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Hospitals must be located in Guerrero, Chiapas, or Mexico states
  • Number of deliveries and cesareans was between 500 and 3000 in 2009

Exclusion Criteria:

  • Inaccessible by car

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    PRONTO training

    Arm Description

    Hospitals randomized to the control arm do not receive any intervention.

    PRONTO training is delivered to medical teams at hospitals randomized to this arm.

    Outcomes

    Primary Outcome Measures

    Perinatal mortality
    Assess perinatal mortality over the 12 month period following the training intervention

    Secondary Outcome Measures

    Death rate from obstetric hemorrhage
    Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
    Death rate from preeclampsia/eclampsia
    Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
    Serious maternal complications
    Assess the number of serious obstetric complications over 12 months following training intervention

    Full Information

    First Posted
    November 18, 2011
    Last Updated
    March 1, 2018
    Sponsor
    Instituto Nacional de Salud Publica, Mexico
    Collaborators
    Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary for Women, Chiapas, Secretary for Women, Mexico state
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01477554
    Brief Title
    PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
    Acronym
    PRONTO
    Official Title
    PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Nacional de Salud Publica, Mexico
    Collaborators
    Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary for Women, Chiapas, Secretary for Women, Mexico state

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency Training Program is an innovative training strategy based on simulations designed to train hospital personnel to respond to obstetric emergencies. The objective of this study is to implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in influencing key behaviors in hospital practices, as well as measuring maternal and neonatal outcomes in intervention versus control hospitals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy Related Complications
    Keywords
    Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team, Simulation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Hospitals randomized to the control arm do not receive any intervention.
    Arm Title
    PRONTO training
    Arm Type
    Experimental
    Arm Description
    PRONTO training is delivered to medical teams at hospitals randomized to this arm.
    Intervention Type
    Other
    Intervention Name(s)
    PRONTO training
    Intervention Description
    PRONTO is an intervention consisting of two training modules for medical professionals. Module 1 is delivered over 2-3 days, takes place in the hospital, and consists of high-fidelity, low-tech simulations. The curriculum employs elements of the Team STEPPS program to strengthen teamwork and leadership skills, and the use of effective communication techniques. The activities and simulations have clear objectives and use evidenced-based medical concepts. Module 2, the follow-up training, uses the same teaching methodology as Module 1 to reinforce teamwork, communication, and emergency response skills, and incorporates new topics such as preeclampsia /eclampsia, shoulder dystocia and pelvic presentation.
    Primary Outcome Measure Information:
    Title
    Perinatal mortality
    Description
    Assess perinatal mortality over the 12 month period following the training intervention
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Death rate from obstetric hemorrhage
    Description
    Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
    Time Frame
    12 months
    Title
    Death rate from preeclampsia/eclampsia
    Description
    Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
    Time Frame
    12 months
    Title
    Serious maternal complications
    Description
    Assess the number of serious obstetric complications over 12 months following training intervention
    Time Frame
    12 months

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitals must be located in Guerrero, Chiapas, or Mexico states Number of deliveries and cesareans was between 500 and 3000 in 2009 Exclusion Criteria: Inaccessible by car
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dilys M Walker, MD
    Organizational Affiliation
    National Institute of Public Health Mexico
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29902983
    Citation
    Fritz J, Lamadrid-Figueroa H, Angeles G, Montoya A, Walker D. Health providers pass knowledge and abilities acquired by training in obstetric emergencies to their peers: the average treatment on the treated effect of PRONTO on delivery attendance in Mexico. BMC Pregnancy Childbirth. 2018 Jun 15;18(1):232. doi: 10.1186/s12884-018-1872-4.
    Results Reference
    derived
    PubMed Identifier
    28319122
    Citation
    Fritz J, Walker DM, Cohen S, Angeles G, Lamadrid-Figueroa H. Can a simulation-based training program impact the use of evidence based routine practices at birth? Results of a hospital-based cluster randomized trial in Mexico. PLoS One. 2017 Mar 20;12(3):e0172623. doi: 10.1371/journal.pone.0172623. eCollection 2017.
    Results Reference
    derived
    PubMed Identifier
    25409895
    Citation
    Walker D, Cohen S, Fritz J, Olvera M, Lamadrid-Figueroa H, Cowan JG, Hernandez DG, Dettinger JC, Fahey JO. Team training in obstetric and neonatal emergencies using highly realistic simulation in Mexico: impact on process indicators. BMC Pregnancy Childbirth. 2014 Nov 20;14:367. doi: 10.1186/s12884-014-0367-1.
    Results Reference
    derived

    Learn more about this trial

    PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact

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