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

Sponsor

Instituto Nacional de Salud Publica, Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT01477554

Collaborator

Mexican National Institute for Women (Other), Mexican Center for Gender Equity and Reproductive Health (Other), Secretary for Women, Chiapas (Other), Secretary for Women, Mexico state (Other)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Complications	Other: PRONTO training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

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 :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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