- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290924
Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
|
|
Active Comparator: Comparison
Training on data collection and reporting
|
Training on data collection and reporting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 day
|
|
institutional intrapartum stillbirth rate
Time Frame: 1 day
|
proportion of all facility births that resulted in intrapartum stillbirth
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
skilled birth attendant knowledge and skills
Time Frame: Pre-test (before training) - post-test (immediately after training) - endline (12 months)
|
score on written and practical examinations on routine and emergency obstetric and newborn care
|
Pre-test (before training) - post-test (immediately after training) - endline (12 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Gomez, Senior Technical Advisor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPP1087303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stillbirth
-
Hawler Medical UniversityCompletedUnexplained StillbirthIraq
-
Centre Hospitalier Universitaire de NīmesCompletedCaesarean Section;Stillbirth
-
Acibadem UniversityCompletedBreast Feeding | Caesarean Section;StillbirthTurkey (Türkiye)
-
Università degli Studi dell'InsubriaNot yet recruitingPregnancy Complications | Delivery;Abnormal;Stillbirth
-
Hacettepe UniversityRecruitingPain | Breastfeeding | Caesarean Section;StillbirthTurkey
-
Centre Hospitalier Universitaire de BesanconCompletedTermination of Pregnancy | Neonatal Death | Stillbirth and Fetal DeathFrance
-
Policlinico HospitalUnknownMicrobial Colonization | Caesarean Section;StillbirthItaly
-
NICHD Global Network for Women's and Children's...CompletedMaternal Morbidity and Mortality | Stillbirth and Neonatal MortalityZambia, India, Pakistan, Kenya, Guatemala, Argentina
-
Stanford UniversityInternational Centre for Diarrhoeal Disease Research, Bangladesh; Thrasher... and other collaboratorsNot yet recruitingInfant Mortality | Child Mortality | Perinatal Mortality | Stillbirth and Neonatal MortalityBangladesh
-
Cukurova UniversityEnrolling by invitationCaesarean Section;Stillbirth | Postpartum ComplicationTurkey
Clinical Trials on Low dose high frequency health worker training approach
-
Emergency Medical Services, Capital Region, DenmarkTrygFonden, DenmarkCompletedOut-Of-Hospital Cardiac ArrestDenmark
-
Ankara UniversityNot yet recruitingLow-Dose High-Frequency CPR Training
-
Rigshospitalet, DenmarkPublic Health Laboratory Ivo de CarneriUnknownNeonatal Death
-
Mbarara University of Science and TechnologyThe Hospital for Sick ChildrenUnknownNeonatal Death | Birth AsphyxiaUganda
-
University of CalgaryNatural Sciences and Engineering Research Council, CanadaCompleted
-
Wake Forest University Health SciencesNational Institute on Minority Health and Health Disparities (NIMHD)CompletedWell-child Care VisitsUnited States
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompleted
-
University of UtahBeijing Sport UniversityCompletedChronic Ankle Instability | Chronic Ankle Instability, CAIChina
-
Universidad Complutense de MadridActive, not recruitingFrailty | Electric Stimulation Therapy | WomenSpain