This trial is active, not recruiting.

Condition pregnancy related complications
Treatment pronto training
Sponsor Instituto Nacional de Salud Publica, Mexico
Collaborator Mexican National Institute for Women
Start date September 2009
End date June 2013
Trial size 24 participants
Trial identifier NCT01477554, 2-845-6519


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
(No Intervention)
Hospitals randomized to the control arm do not receive any intervention.
PRONTO training is delivered to medical teams at hospitals randomized to this arm.
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.

Primary Outcomes

Perinatal mortality
time frame: 12 months

Secondary Outcomes

Death rate from obstetric hemorrhage
time frame: 12 months
Death rate from preeclampsia/eclampsia
time frame: 12 months
Serious maternal complications
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Principal investigator Dilys M Walker, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Instituto Nacional de Salud Publica, Mexico.