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

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
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
NCT ID
NCT01477554
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
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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