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

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.

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Key information

Conditions

Pregnancy Related Complications Death Female Urogenital Diseases and Pregnancy Complications Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRONTO training

Other

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

Assess perinatal mortality over the 12 month period following the training intervention

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Salud Publica, Mexico

Other

Collaborators

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

Registry information

Acronym: PRONTO

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: Nov 22, 2011
Registry last updated: Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed