Pregnancy Related ComplicationsPRONTONCT01477554
PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
A study testing PRONTO training in people with Pregnancy Related Complications, run by Instituto Nacional de Salud Publica, Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy Related Complications
- What is being tested?
- PRONTO training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitals must be located in Guerrero, Chiapas, or Mexico states
- Number of deliveries and cesareans was between 500 and 3000 in 2009
Who cannot join
- Inaccessible by car
About this study
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.
- Conditions
- Pregnancy Related Complications
- Being tested
- PRONTO training
- Keywords
- Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team, Simulation
- Medical subject headings
- Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRONTO trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Hospitals randomized to the control arm do not receive any intervention. |
| PRONTO training | Experimental | PRONTO training is delivered to medical teams at hospitals randomized to this arm. Receives: Other: PRONTO training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal mortality
Assess perinatal mortality over the 12 month period following the training intervention
Measured: 12 months
Secondary outcomes (3)
Death rate from obstetric hemorrhage
Number of deaths from obstetric hemorrhage/total number of obstetric hemorrhages
Measured: 12 months
Death rate from preeclampsia/eclampsia
Number of deaths from preeclampsia/eclampsia / totaly number of preeclampsia/eclampsia cases
Measured: 12 months
Serious maternal complications
Assess the number of serious obstetric complications over 12 months following training intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Related ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary for Women, Chiapas, Secretary for Women, Mexico state
- Responsible party
- Principal investigator, Dilys Walker, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Dilys M Walker, MD, Principal investigator, National Institute of Public Health Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477554
- Sponsor's protocol ID
- 2-845-6519
- Acronym
- PRONTO
- Status last verified
- Mar 2018
- First submitted
- 18 Nov 2011
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29902983Fritz 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.
PubMed 28319122Walker 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.
PubMed 25409895
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
- ClinicalTrials.gov ID
- NCT01477554
- Acronym / sponsor ID
- PRONTO / 2-845-6519
- Conditions
- Pregnancy Related Complications
- Keywords
- Women, Maternal morbidity, Maternal mortality, Perinatal mortality, Perinatal morbidity, Training, Obstetric Emergency, Medical team
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Mexican National Institute for Women, Mexican Center for Gender Equity and Reproductive Health, Secretary for Women, Chiapas, Secretary for Women, Mexico state
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Hospitals randomized to the control arm do not receive any intervention. |
| PRONTO training | Experimental | Other: PRONTO trainingPRONTO training is delivered to medical teams at hospitals randomized to this arm. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitals must be located in Guerrero, Chiapas, or Mexico states
- Number of deliveries and cesareans was between 500 and 3000 in 2009
Key exclusion criteria (1 listed)
- Inaccessible by car
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRONTO trainingPRONTO 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. | Other | PRONTO training |
Primary outcome
Perinatal mortality
Time frame: 12 months
Assess perinatal mortality over the 12 month period following the training intervention
3 secondary outcomes
Death rate from obstetric hemorrhage
Time frame: 12 months
Death rate from preeclampsia/eclampsia
Time frame: 12 months
Serious maternal complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Derived from this study: PubMed 29902983Fritz 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.
- Derived from this study: PubMed 28319122Fritz 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.
- Derived from this study: PubMed 25409895Walker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilys M Walker, MD principal investigator
National Institute of Public Health Mexico
Questions about this trial
What is this clinical trial studying?
A study testing PRONTO training in people with Pregnancy Related Complications, run by Instituto Nacional de Salud Publica, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.