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

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ClinicalTrials.gov Identifier: NCT01477554
Recruitment Status : Unknown
Verified November 2011 by Dilys Walker, Instituto Nacional de Salud Publica, Mexico.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pregnancy Related Complications Other: PRONTO training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Study Start Date : September 2009
Estimated Study Completion Date : June 2013
Arms and Interventions

Arm Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :
  1. Perinatal mortality [ Time Frame: 12 months ]
    Assess perinatal mortality over the 12 month period following the training intervention

Secondary Outcome Measures :
  1. Death rate from obstetric hemorrhage [ Time Frame: 12 months ]
    Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages

  2. Death rate from preeclampsia/eclampsia [ Time Frame: 12 months ]
    Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases

  3. Serious maternal complications [ Time Frame: 12 months ]
    Assess the number of serious obstetric complications over 12 months following training intervention

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477554

Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dilys Walker, Profesora Asociada C, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT01477554     History of Changes
Other Study ID Numbers: 2-845-6519
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Dilys Walker, Instituto Nacional de Salud Publica, Mexico:
Maternal morbidity
Maternal mortality
Perinatal mortality
Perinatal morbidity
Obstetric Emergency
Medical team

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes