Skip to main content
Clinical Trials/NCT03891030
NCT03891030
Unknown
Not Applicable

Effectiveness of Checklist Based Box System Interventions (CBBSI) on Improving Utilization of Maternal Health Service in North West, Ethiopia: a Cluster Randomized Controlled Trial

Jimma University1 site in 1 country1,200 target enrollmentNovember 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Health Service
Sponsor
Jimma University
Enrollment
1200
Locations
1
Primary Endpoint
Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3)
Last Updated
7 years ago

Overview

Brief Summary

Maternal mortality is still high in Ethiopia. Antenatal care (ANC), use of skilled delivery attendants and postnatal care (PNC) services are key maternal health care services that can significantly reduce maternal mortality. However, interventions applied to the continued utilization of these key maternal heath services in a continuum of care approach (i.e. early initiation of ANC and continued utilization up to four plus vists, health facility delivery attended by skilled health care providers and attending three PNC visits) were not well applied and studied.

Hence, the purpose of this study is to test the effectiveness of checklist based box system interventions on improving utilization of maternal health service (Antenatal care, skilled birth attendance and postnatal care) utilization.

Detailed Description

Cluster Randomized controlled trial study design will be employed. The sample size for this study was calculated based on the recommendations for sample size calculations for cluster randomized controlled trials with fixed number of clusters, by using STATA. The following assumptions were considered: to detect an increase of postnatal care three utilization from 16% to 28% from previous study, number of clusters available-30, with 95% confidence interval and 80% power, intra-cluster correlation coefficient of 0.04849 from similar studies, 15 clusters per arm. The sample size was calculated to determine number of observations required per cluster, for two-sample comparison of proportions (using normal approximation), Assuming individual randomization, sample size per arm is 194. Then allowing for cluster randomization, average cluster size required is 40, and the final sample size is 1200 pregnant mothers (600 in intervention, and 600 in control). Data analysis will take place in two levels (cluster and individual). Risk ration will be computed at cluster level, and the results of this cluster summary will be compared using t-test. Primary and secondary outcomes will be compared between intervention and control groups with random effects logistic regression models, taking account of clustering.

Registry
clinicaltrials.gov
Start Date
November 22, 2018
End Date
November 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Netsanet Belete

Msc

Jimma University

Eligibility Criteria

Inclusion Criteria

  • Mothers residing in three of the selected districts Debre-Markos, Gozamin and Machakel districts Mother who are positive for Stanback et al, 1999 pregnancy screening criteria and found HCG positive (confirmed pregnancy) Gestational age of less than 16 weeks Mothers willing to participate in the study

Exclusion Criteria

  • Women who have severe psychological illness, which could interfere with, consent and study participation, Those who have sever clinical complications that need hospitalization Mothers who need special type of ANC follow-up, other than the recommended focused ANC

Outcomes

Primary Outcomes

Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3)

Time Frame: 42 days after delivery

Proportion of mothers receiving continued maternal health service (four ANC, skilled birth attendance and PNC three) in the intervention and control clusters, assessed using standard questionnaire

Secondary Outcomes

  • Institutional delivery attended by skilled Birth attendance(after 40 weeks of gestation)
  • Early Initiation of Antenatal care (Before 16 Weeks of Gestation)(16 weeks of gestation)
  • Postnatal care follow-up (First 6 hours, 6 days and 6 weeks of delivery)(42 days after delivery)
  • Knowledge towards maternal health service(42 days after delivery)
  • Attending four antenatal care follow up, (36-40 weeks of gestation)(40 weeks of gestation)

Study Sites (1)

Loading locations...

Similar Trials