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

Not Applicable

Completed

• Conditions: Pregnancy Related Complications
• Interventions: Other: PRONTO training

• Registration Number: NCT01477554
• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2012-01
• Study Completion: 2013-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRONTO training	PRONTO training	PRONTO training is delivered to medical teams at hospitals randomized to this arm.

Primary Outcome Measures

Name	Time	Method
Perinatal mortality	12 months	Assess perinatal mortality over the 12 month period following the training intervention

Secondary Outcome Measures

Name	Time	Method
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
Death rate from obstetric hemorrhage	12 months	Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages