Clinical trial NCT01477554: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Official title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related Complications
Keywords: Women
Maternal morbidity
Maternal mortality
Perinatal mortality
Perinatal morbidity
Training
Obstetric Emergency
Medical team
Simulation
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Mexican National Institute for Women
name: Mexican Center for Gender Equity and Reproductive Health
name: Secretary for Women, Chiapas
name: Secretary for Women, Mexico state
First posted: 2011-11-22
Enrollment: 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Perinatal mortality
timeFrame: 12 months
Secondary outcomes:
measure: Death rate from obstetric hemorrhage
timeFrame: 12 months
measure: Death rate from preeclampsia/eclampsia
timeFrame: 12 months
measure: Serious maternal complications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Public Health Mexico
name: Dilys M Walker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.