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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01477554
Acronym
PRONTO
Enrollment
24
Registered
2011-11-22
Start date
2009-09-30
Completion date
2013-02-28
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related Complications

Keywords

Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team, Simulation

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.

Interventions

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perinatal mortality12 monthsAssess perinatal mortality over the 12 month period following the training intervention

Secondary

MeasureTime frameDescription
Serious maternal complications12 monthsAssess the number of serious obstetric complications over 12 months following training intervention
Death rate from obstetric hemorrhage12 monthsNumber of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
Death rate from preeclampsia/eclampsia12 monthsNumber of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026