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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mexican National Institute for Women
Mexican Center for Gender Equity and Reproductive Health
Secretary for Women, Chiapas
Secretary for Women, Mexico state
Information provided by (Responsible Party):
Dilys Walker, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT01477554
First received: November 18, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 18, 2011
November 18, 2011
September 2009
Not Provided
Perinatal mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Assess perinatal mortality over the 12 month period following the training intervention
Same as current
No Changes Posted
  • Death rate from obstetric hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
  • Death rate from preeclampsia/eclampsia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
  • Serious maternal complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess the number of serious obstetric complications over 12 months following training intervention
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Pregnancy Related Complications
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.
  • No Intervention: Control
    Hospitals randomized to the control arm do not receive any intervention.
  • Experimental: PRONTO training
    PRONTO training is delivered to medical teams at hospitals randomized to this arm.
    Intervention: Other: PRONTO training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
June 2013
Not Provided

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
Not Provided
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01477554
2-845-6519
No
Dilys Walker, Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Salud Publica, Mexico
  • Mexican National Institute for Women
  • Mexican Center for Gender Equity and Reproductive Health
  • Secretary for Women, Chiapas
  • Secretary for Women, Mexico state
Principal Investigator: Dilys M Walker, MD National Institute of Public Health Mexico
Instituto Nacional de Salud Publica, Mexico
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP