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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related Complications

Intervention / Treatment
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* Other: PRONTO training


Participation Criteria
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Eligibility Criteria
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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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Hospitals randomized to the control arm do not receive any intervention. | |
| Experimental: PRONTO training<br>PRONTO training is delivered to medical teams at hospitals randomized to this arm. | Other: PRONTO training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal mortality | Assess perinatal mortality over the 12 month period following the training intervention | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simulation, Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team