Checklist Based Box System Interventions

Maternal Health Service Clinical Trial

— CBBSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03891030
• Other study ID #: CBBSI/2019
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: November 2019

Study information

• Verified date: March 2019
• Source: Jimma University
• Contact: Netsanet Belete, Msc
• Phone: +25148075941
• Email: netsanetb2009[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Health Service

Intervention

Other:
• Checklist Based Box system intervention
The intervention has both behavioural change and service utilization drop out tracing mechanism. Special type of boxes designed to schedule health educations and continued service utilization monitoring boxes will be placed at health posts and health centers respectively. Community level survey will be conducted to identify suspected pregnant mothers using stanback et al, 1999 checklist, and mothers are linked to health centers. Then, they will be followed for their subsequent attendance of consecutive maternal health services (ANC 2nd-third PNC). Mothers who fail to utilize the service will be traced; will get person-centered health education to continue the service.

Locations

Country	Name	City	State
Ethiopia	East Gojjam zone	Debre Markos	Northwest

Sponsors (2)

Lead Sponsor	Collaborator
Jimma University	Armauer Hansen Research Institute (AHRI)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3)	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	42 days after delivery
Secondary	Early Initiation of Antenatal care (Before 16 Weeks of Gestation)	Proportion of mothers attending ANC before 16 weeks of gestation in the intervention and control clusters, assessed using 4-visit WHO ANC Model	16 weeks of gestation
Secondary	Attending four antenatal care follow up, (36-40 weeks of gestation)	Proportion of mothers attending the fourth ANC in the intervention and control clusters, assessed using 4-visit WHO ANC Model	40 weeks of gestation
Secondary	Institutional delivery attended by skilled Birth attendance	Proportion of mothers attending institutional delivery in the intervention and control clusters, assessed using standard questionnaire	after 40 weeks of gestation
Secondary	Postnatal care follow-up (First 6 hours, 6 days and 6 weeks of delivery)	Proportion of mothers attending the third PNC in the intervention and control clusters: assessed using standard questionnaire	42 days after delivery
Secondary	Knowledge towards maternal health service	Knowledge of mothers towards healthy pregnancy, delivery and the postnatal care period in the intervention and control clusters: assessed using Knowledge questionnaire	42 days after delivery