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

March 1, 2018 updated by: Dilys Walker, Instituto Nacional de Salud Publica, Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal mortality
Time Frame: 12 months
Assess perinatal mortality over the 12 month period following the training intervention
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death rate from obstetric hemorrhage
Time Frame: 12 months
Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
12 months
Death rate from preeclampsia/eclampsia
Time Frame: 12 months
Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
12 months
Serious maternal complications
Time Frame: 12 months
Assess the number of serious obstetric complications over 12 months following training intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (ESTIMATE)

November 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-845-6519

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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