StillbirthNCT03290924
Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
A study testing Low dose high frequency health worker training approach and Active Comparison in people with Stillbirth and Neonatal Death, run by Jhpiego.
Trial summary
This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stillbirth, Neonatal Death
- What is being tested?
- Low dose high frequency health worker training approach and Active Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 28 Feb 2017
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Public or faith based hospital
- At least three skilled birth attendants on staff
- At least 30 births per month
- Health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period
Who cannot join
- Private hospital
- Public or faith based hospital with less than three skilled birth attendants on staff
- Public or faith based hospital with less than 30 births per month
- Health providers who decline to participate
About this study
This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.
Read the detailed description
In-service training for skilled birth attendants (SBAs) is one of the most common interventions to address lack of knowledge and skills. However, these training interventions are seldom evaluated for effectiveness in improving learning or performance.
This study study is a cluster-randomized waitlist trial implemented in 40 public and mission hospitals in Ghana. It assesses the effect of a low-dose, high-frequency (LDHF) training approach to update hospital-based SBAs in key evidence-based intrapartum and immediate newborn care practices, using current global guidelines.The LDHF approach includes two 4-day onsite sessions (low dose) with weekly practice sessions, SMS quizzes and reminders, and mentoring via mobile phone and onsite visits between trainings (high frequency). The low-dose sessions include competency acquisition through simulation, case-based learning, and small content packages spread over short time intervals.
Eligible hospitals will be stratified by geographic region and caseload, and then randomly assigned to one of four implementation waves. The pipeline randomization allows for rigorous evaluation while the program is rolled out to all facilities.
- Conditions
- Stillbirth, Neonatal Death
- Being tested
- Low dose high frequency health worker training approach, Active Comparison
- Keywords
- institutional delivery
- Medical subject headings
- Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose high frequency health worker training approachBehavioural
- Two 4-day training sessions for skilled birth attendants
- 1-day peer practice coordinator training after first training session
- Weekly, peer-led practice sessions using MamaNatalie® and NeoNatalie™ anatomic models
- SMS reminder messages and quizzes
- Routine telephone calls between master mentors and peer practice coordinators, and between project staff and master mentors
- Health information officer training
- Data collection and use training
- Supply of simulators, newborn resuscitation equipment, and delivery sets
Active ComparisonBehavioural
Training on data collection and reporting
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices Receives: Behavioral: Low dose high frequency health worker training approach |
| Comparison | Active comparator | Training on data collection and reporting Receives: Behavioral: Active Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
institutional twenty-four hour newborn mortality rate
death within 24 hours, or before discharge, of a newborn who breathed at birth
Measured: 1 day
institutional intrapartum stillbirth rate
proportion of all facility births that resulted in intrapartum stillbirth
Measured: 1 day
Secondary outcomes (1)
skilled birth attendant knowledge and skills
score on written and practical examinations on routine and emergency obstetric and newborn care
Measured: Pre-test (before training) - post-test (immediately after training) - endline (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Sep 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Patricia Gomez, Principal investigator, Senior Technical Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290924
- Sponsor's protocol ID
- OPP1087303
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez PP, Nelson AR, Asiedu A, Addo E, Agbodza D, Allen C, Appiagyei M, Bannerman C, Darko P, Duodu J, Effah F, Tappis H. Accelerating newborn survival in Ghana through a low-dose, high-frequency health worker training approach: a cluster randomized trial. BMC Pregnancy Childbirth. 2018 Mar 22;18(1):72. doi: 10.1186/s12884-018-1705-5.
PubMed 29566659
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
- ClinicalTrials.gov ID
- NCT03290924
- Acronym / sponsor ID
- OPP1087303
- Conditions
- Stillbirth, Neonatal Death
- Keywords
- institutional delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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.
This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.
Detailed description
In-service training for skilled birth attendants (SBAs) is one of the most common interventions to address lack of knowledge and skills. However, these training interventions are seldom evaluated for effectiveness in improving learning or performance.
This study study is a cluster-randomized waitlist trial implemented in 40 public and mission hospitals in Ghana. It assesses the effect of a low-dose, high-frequency (LDHF) training approach to update hospital-based SBAs in key evidence-based intrapartum and immediate newborn care practices, using current global guidelines.The LDHF approach includes two 4-day onsite sessions (low dose) with weekly practice sessions, SMS quizzes and reminders, and mentoring via mobile phone and onsite visits between trainings (high frequency). The low-dose sessions include competency acquisition through simulation, case-based learning, and small content packages spread over short time intervals.
Eligible hospitals will be stratified by geographic region and caseload, and then randomly assigned to one of four implementation waves. The pipeline randomization allows for rigorous evaluation while the program is rolled out to all facilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Low dose high frequency health worker training approachLow-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices |
| Comparison | Active comparator | Behavioral: Active ComparisonTraining on data collection and reporting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Public or faith based hospital
- At least three skilled birth attendants on staff
- At least 30 births per month
- Health providers who attend births in participating health facilities and consent to be assessed at the time of enrollment and at several points in time over the study period
Key exclusion criteria (4 listed)
- Private hospital
- Public or faith based hospital with less than three skilled birth attendants on staff
- Public or faith based hospital with less than 30 births per month
- Health providers who decline to participate
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 |
|---|---|---|
| Low dose high frequency health worker training approach* Two 4-day training sessions for skilled birth attendants * 1-day peer practice coordinator training after first training session * Weekly, peer-led practice sessions using MamaNatalie® and NeoNatalie™ anatomic models * SMS reminder messages and quizzes * Routine telephone calls between master mentors and peer practice coordinators, and between project staff and master mentors * Health information officer training * Data collection and use training * Supply of simulators, newborn resuscitation equipment, and delivery sets | Behavioural | Intervention |
| Active ComparisonTraining on data collection and reporting | Behavioural | Comparison |
Primary outcome
institutional twenty-four hour newborn mortality rate
Time frame: 1 day
death within 24 hours, or before discharge, of a newborn who breathed at birth
institutional intrapartum stillbirth rate
Time frame: 1 day
proportion of all facility births that resulted in intrapartum stillbirth
1 secondary outcome
skilled birth attendant knowledge and skills
Time frame: Pre-test (before training) - post-test (immediately after training) - endline (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 25 Sep 2017.
- Derived from this study: PubMed 29566659Gomez PP, Nelson AR, Asiedu A, Addo E, Agbodza D, Allen C, Appiagyei M, Bannerman C, Darko P, Duodu J, Effah F, Tappis H. Accelerating newborn survival in Ghana through a low-dose, high-frequency health worker training approach: a cluster randomized trial. BMC Pregnancy Childbirth. 2018 Mar 22;18(1):72. doi: 10.1186/s12884-018-1705-5.
- Individual participant dataSharing planned: No
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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.
Patricia Gomez principal investigator
Senior Technical Advisor
Questions about this trial
What is this clinical trial studying?
A study testing Low dose high frequency health worker training approach and Active Comparison in people with Stillbirth and Neonatal Death, run by Jhpiego.
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 4 inclusion and 4 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 25 Sep 2017. 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?
institutional twenty-four hour newborn mortality rate (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03290924, which also lists 1 linked publication.
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 25 Sep 2017.