TY - JOUR
T1 - Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia
T2 - Study protocol for a cluster-randomized controlled trial
AU - Kurji, Jaameeta
AU - Kulkarni, Manisha A.
AU - Gebretsadik, Lakew Abebe
AU - Wordofa, Muluemebet Abera
AU - Morankar, Sudhakar
AU - Bedru, Kunuz Haji
AU - Bulcha, Gebeyehu
AU - Thavorn, Kednapa
AU - Labonte, Ronald
AU - Taljaard, Monica
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/12/4
Y1 - 2019/12/4
N2 - Background: Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Ethiopia in 2016 reported doing so at a health facility. Maternity waiting homes (MWHs) have been introduced to overcome geographical and financial barriers to institutional births but there is no conclusive evidence as to their effectiveness. We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. Methods: A parallel, three-arm, stratified, cluster-randomized controlled trial design is being employed to evaluate intervention effects on institutional births, which is the primary outcome. Trial arms are: (1) upgraded MWH + religious/community leader training; (2) leader training alone; and (3) standard care. Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round. Outcome assessments will be made using repeat cross-sectional surveys at baseline and 24 months postintervention. An intention to treat approach will be used and the primary outcome analysed using generalized linear mixed models with a random effect for cluster and time. A cost-effectiveness analysis will also be conducted from a societal perspective. Discussion: This is one of the first trials to evaluate the effectiveness of upgraded MWHs and will provide much needed evidence to policy makers about aspects of functionality and the community engagement required as they scale-up this programme in Ethiopia. Trial registration: ClinicalTrial.gov, NCT03299491. Retrospectively registered on 3 October 2017.
AB - Background: Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Ethiopia in 2016 reported doing so at a health facility. Maternity waiting homes (MWHs) have been introduced to overcome geographical and financial barriers to institutional births but there is no conclusive evidence as to their effectiveness. We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. Methods: A parallel, three-arm, stratified, cluster-randomized controlled trial design is being employed to evaluate intervention effects on institutional births, which is the primary outcome. Trial arms are: (1) upgraded MWH + religious/community leader training; (2) leader training alone; and (3) standard care. Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round. Outcome assessments will be made using repeat cross-sectional surveys at baseline and 24 months postintervention. An intention to treat approach will be used and the primary outcome analysed using generalized linear mixed models with a random effect for cluster and time. A cost-effectiveness analysis will also be conducted from a societal perspective. Discussion: This is one of the first trials to evaluate the effectiveness of upgraded MWHs and will provide much needed evidence to policy makers about aspects of functionality and the community engagement required as they scale-up this programme in Ethiopia. Trial registration: ClinicalTrial.gov, NCT03299491. Retrospectively registered on 3 October 2017.
KW - Cluster-randomized controlled trial
KW - Community engagement
KW - Complex interventions
KW - Ethiopia
KW - Institutional birth
KW - Maternal health care
KW - Maternity waiting home
KW - RE-AIM framework
KW - Three-Delays model
UR - http://www.scopus.com/inward/record.url?scp=85075998597&partnerID=8YFLogxK
U2 - 10.1186/s13063-019-3755-z
DO - 10.1186/s13063-019-3755-z
M3 - Article
C2 - 31801584
AN - SCOPUS:85075998597
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 671
ER -