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

Pregnancy Related Complications Clinical Trial

— PRONTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477554
• Other study ID #: 2-845-6519
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: March 1, 2018
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: March 2018
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Pregnancy Related Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	Mexican Center for Gender Equity and Reproductive Health, Mexican National Institute for Women, Secretary for Women, Chiapas, Secretary for Women, Mexico state

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal mortality	Assess perinatal mortality over the 12 month period following the training intervention	12 months
Secondary	Death rate from obstetric hemorrhage	Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages	12 months
Secondary	Death rate from preeclampsia/eclampsia	Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases	12 months
Secondary	Serious maternal complications	Assess the number of serious obstetric complications over 12 months following training intervention	12 months