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

NCT ID: NCT01477554

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Hospitals randomized to the control arm do not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

PRONTO training

PRONTO training is delivered to medical teams at hospitals randomized to this arm.

Group Type EXPERIMENTAL

PRONTO training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Mexican National Institute for Women

UNKNOWN

Sponsor Role collaborator

Mexican Center for Gender Equity and Reproductive Health

UNKNOWN

Sponsor Role collaborator

Secretary for Women, Chiapas

UNKNOWN

Sponsor Role collaborator

Secretary for Women, Mexico state

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Dilys Walker

Profesora Asociada C

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilys M Walker, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health Mexico

References

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Fritz J, Lamadrid-Figueroa H, Angeles G, Montoya A, Walker D. Health providers pass knowledge and abilities acquired by training in obstetric emergencies to their peers: the average treatment on the treated effect of PRONTO on delivery attendance in Mexico. BMC Pregnancy Childbirth. 2018 Jun 15;18(1):232. doi: 10.1186/s12884-018-1872-4.

Reference Type DERIVED
PMID: 29902983 (View on PubMed)

Fritz J, Walker DM, Cohen S, Angeles G, Lamadrid-Figueroa H. Can a simulation-based training program impact the use of evidence based routine practices at birth? Results of a hospital-based cluster randomized trial in Mexico. PLoS One. 2017 Mar 20;12(3):e0172623. doi: 10.1371/journal.pone.0172623. eCollection 2017.

Reference Type DERIVED
PMID: 28319122 (View on PubMed)

Walker D, Cohen S, Fritz J, Olvera M, Lamadrid-Figueroa H, Cowan JG, Hernandez DG, Dettinger JC, Fahey JO. Team training in obstetric and neonatal emergencies using highly realistic simulation in Mexico: impact on process indicators. BMC Pregnancy Childbirth. 2014 Nov 20;14:367. doi: 10.1186/s12884-014-0367-1.

Reference Type DERIVED
PMID: 25409895 (View on PubMed)

Other Identifiers

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2-845-6519

Identifier Type: -

Identifier Source: org_study_id

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