Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Checklist Based Box System Interventions (CBBSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891030
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Armauer Hansen Research Institute (AHRI)
Information provided by (Responsible Party):
Netsanet Belete, Jimma University

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.


Condition or disease Intervention/treatment Phase
Maternal Health Service Other: Checklist Based Box system intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Checklist Based Box system
Pregnant mothers will receive scheduled person-centered health educations starting from: they are identified as suspected pregnant mother up to attending their third PNC visit. In between the first ANC and the third PNC drop out tracing mechanisms will be applied, for mothers who fail to utilize the recommended maternal health services.
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.

No Intervention: Routine maternal health care
Pregnant mothers in this arm will receive the usual routine maternal health care.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Early Initiation of Antenatal care (Before 16 Weeks of Gestation) [ Time Frame: 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

  2. Attending four antenatal care follow up, (36-40 weeks of gestation) [ Time Frame: 40 weeks of gestation ]
    Proportion of mothers attending the fourth ANC in the intervention and control clusters, assessed using 4-visit WHO ANC Model

  3. Institutional delivery attended by skilled Birth attendance [ Time Frame: after 40 weeks of gestation ]
    Proportion of mothers attending institutional delivery in the intervention and control clusters, assessed using standard questionnaire

  4. Postnatal care follow-up (First 6 hours, 6 days and 6 weeks of delivery) [ Time Frame: 42 days after delivery ]
    Proportion of mothers attending the third PNC in the intervention and control clusters: assessed using standard questionnaire

  5. Knowledge towards maternal health service [ Time Frame: 42 days after delivery ]
    Knowledge of mothers towards healthy pregnancy, delivery and the postnatal care period in the intervention and control clusters: assessed using Knowledge questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891030


Contacts
Layout table for location contacts
Contact: Netsanet Belete, Msc +25148075941 netsanetb2009@gmail.com
Contact: Mulusew Gerbaba, PhD +251940625429 mulusew.gerbaba@gmail.com

Locations
Layout table for location information
Ethiopia
East Gojjam zone Recruiting
Debre Markos, Northwest, Ethiopia
Contact: Aklog Nigussie, Bsc       Aklog.nigussie@gmail.com   
Contact: Feteh Sendek, Bsc         
Sponsors and Collaborators
Jimma University
Armauer Hansen Research Institute (AHRI)
Investigators
Layout table for investigator information
Principal Investigator: Netsanet Belete, Msc Jimma University
Study Director: Mulusew Gerbaba, PhD Jimma University
Study Director: Gurmesa Tura, PhD Jimma University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Netsanet Belete, Msc, Jimma University
ClinicalTrials.gov Identifier: NCT03891030    
Other Study ID Numbers: CBBSI/2019
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant flow, outcome measure statistical analysis

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No