PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact|
- Perinatal mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assess perinatal mortality over the 12 month period following the training intervention
- Death rate from obstetric hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
- Death rate from preeclampsia/eclampsia [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
- Serious maternal complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assess the number of serious obstetric complications over 12 months following training intervention
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||June 2013|
No Intervention: Control
Hospitals randomized to the control arm do not receive any intervention.
Experimental: PRONTO training
PRONTO training is delivered to medical teams at hospitals randomized to this arm.
Other: PRONTO training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477554
|Principal Investigator:||Dilys M Walker, MD||National Institute of Public Health Mexico|