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CompletedNCT03290924Updated Sep 25, 2017

Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach

An interventional study of Low dose high frequency health worker training approach and Active Comparison in Stillbirth and Neonatal Death, sponsored by Jhpiego. Completed. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Jhpiego · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Sep 2014, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stillbirth
  • Neonatal Death

Keywords

  • institutional delivery
03

In context

Stillbirth

121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.

This study's enrollment of 40 is below the median of 476 across 65 interventional studies indexed under Stillbirth.

Browse Stillbirth studies →

Lead sponsor

Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

INCLUSION CRITERIA - FACILITIES:

  • Public or faith based hospital
  • At least three skilled birth attendants on staff
  • At least 30 births per month

EXCLUSION CRITERIA - FACILITIES:

  • 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

INCLUSION CRITERIA - SERVICE PROVIDERS:

* 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

EXCLUSION CRITERIA - SERVICE PROVIDERS:

* Health providers who decline to participate

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention

    Low-dose high-frequency health worker training approach to update skilled birth attendants in key evidence-based intrapartum and immediate newborn care practices

    Behavioral: Low dose high frequency health worker training approach

  • Active comparator
    Comparison

    Training on data collection and reporting

    Behavioral: Active Comparison

Interventions

  • BehavioralLow 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

  • BehavioralActive Comparison

    Training on data collection and reporting

06

What researchers measure

Primary outcomes

  1. institutional twenty-four hour newborn mortality rate

    death within 24 hours, or before discharge, of a newborn who breathed at birth

    Time frame: 1 day

  2. institutional intrapartum stillbirth rate

    proportion of all facility births that resulted in intrapartum stillbirth

    Time frame: 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

    Time frame: Pre-test (before training) - post-test (immediately after training) - endline (12 months)

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Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2014 to primary completion in Feb 2017, 29 months.

Of 25 interventional studies with no phase under Stillbirth, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 31. This study's 29 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Sep 25, 2017
StartActual
Sep 1, 2014
Primary completionActual
Feb 28, 2017
CompletionActual
Feb 28, 2017
Last update
Sep 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03290924
Lead sponsor
Jhpiego
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Sep 1, 2014
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Sep 25, 2017

Study contacts

Patricia Gomez
principal investigator · Senior Technical Advisor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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