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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
  Purpose

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 Intervention
Pregnancy Related Complications
 Other: PRONTO training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact

Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • Perinatal mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess perinatal mortality over the 12 month period following the training intervention


Secondary Outcome Measures:
  • 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


Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Arms Assigned Interventions
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.

  Eligibility

Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Dilys M Walker, MD National Institute of Public Health Mexico
  More Information

No publications provided

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
Study First Received: November 18, 2011
Last Updated: November 18, 2011
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
Mexico: Ministry of Health

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
Women
Maternal morbidity
Maternal mortality
Perinatal mortality
Perinatal morbidity
 Training
Obstetric Emergency
Medical team
Simulation

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013