PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact (PRONTO)
|ClinicalTrials.gov Identifier: NCT01477554|
Recruitment Status : Unknown
Verified November 2011 by Dilys Walker, Instituto Nacional de Salud Publica, Mexico.
Recruitment status was: Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
|Condition or disease||Intervention/treatment|
|Pregnancy Related Complications||Other: PRONTO training|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact|
|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.
- Perinatal mortality [ Time Frame: 12 months ]Assess perinatal mortality over the 12 month period following the training intervention
- Death rate from obstetric hemorrhage [ Time Frame: 12 months ]Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
- Death rate from preeclampsia/eclampsia [ Time Frame: 12 months ]Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
- Serious maternal complications [ Time Frame: 12 months ]Assess the number of serious obstetric complications over 12 months following training intervention
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477554
|Principal Investigator:||Dilys M Walker, MD||National Institute of Public Health Mexico|