68 At the end of 4 weeks, invitation kits will be mailed out to service users and carers from participating clusters.
All pregnant women and their home- or facility-born live births within participating clusters will be eligible for enrollment in this study.
A declaration will be signed by the representatives of the participating clusters which should be posted in the nursing homes' foyers.
The DCC randomized participating clusters within each country to either the lyophilized meat or cereal intervention using toddler stunting rates as the matching criterion; all clusters had stunting rates greater than 20%.
The primary outcome is the difference in the perinatal mortality rate (fresh stillbirths or neonatal deaths prior to 7 days after birth) among births ≥1500 grams across the three participating clusters pre vs. post intervention.
At the same time, one may argue that in spite of the lack of equipoise all participating clusters will receive the seemingly superior experimental intervention at some point during the study.
The order in which the different surgery wards will receive the program is determined at random, allowing the full implementation of intervention in all participating clusters by the end of the trial [ 24].
This two year prospective pre-post study will evaluate the impact of a package of interventions, including HBB and essential newborn care training [ 18] and provision of equipment, on the perinatal mortality rate (lives saved) in the participating clusters of the Global Network before and after implementation in facilities that serve the clusters.
To enhance comparability, a blinded researcher (NHC) stratified and matched participating clusters according to the following criteria: percentage of patients in practice from ethnic minorities, type of practice (single handed, one or more partner practice, or healthcare centre), practice location (urban/rural), age of general practitioner, and sex of general practitioner.
Using a stepped wedge design also enables all participating clusters to ultimately receive the EBCD intervention, which is an advantage when working with a vulnerable population group where it is not ethical to withhold an intervention that is perceived to be beneficial.
