NCT03290924

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

September 19, 2017

Last Update Submit

September 21, 2017

Conditions

StillbirthNeonatal Death

Keywords

institutional delivery

Outcome Measures

Primary Outcomes (2)

  • institutional twenty-four hour newborn mortality rate

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

    1 day

  • institutional intrapartum stillbirth rate

    proportion of all facility births that resulted in intrapartum stillbirth

    1 day

Secondary Outcomes (1)

  • skilled birth attendant knowledge and skills

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

Study Arms (2)

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

Behavioral: Low dose high frequency health worker training approach

Comparison

ACTIVE COMPARATOR

Training on data collection and reporting

Behavioral: Active Comparison

Interventions

Low dose high frequency health worker training approachBEHAVIORAL

* 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

Intervention
Active ComparisonBEHAVIORAL

Training on data collection and reporting

Comparison

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 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
  • \* Health providers who decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29566659DERIVED

MeSH Terms

Conditions

StillbirthPerinatal Death

Condition Hierarchy (Ancestors)

Fetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia Gomez

    Senior Technical Advisor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 25, 2017

Study Start

September 1, 2014

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share