Maternal Health ServiceCBBSINCT03891030
Checklist Based Box System Interventions
A study testing Checklist Based Box system intervention in people with Maternal Health Service, run by Jimma University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health Service
- What is being tested?
- Checklist Based Box system intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteEthiopia
- Study dates
- 22 Nov 2018to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
East Gojjam zone
Debre Markos, Northwest
Aklog Nigussie, Bsc, Aklog.nigussie@gmail.com
Feteh Sendek, Bsc
About this study
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
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.
Read the 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.
- Conditions
- Maternal Health Service
- Being tested
- Checklist Based Box system intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist Based Box system interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Checklist Based Box system | Experimental | 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. Receives: Other: Checklist Based Box system intervention |
| Routine maternal health care | No intervention | Pregnant mothers in this arm will receive the usual routine maternal health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 42 days after delivery
Secondary outcomes (5)
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
Measured: 16 weeks of gestation
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
Measured: 40 weeks of gestation
Institutional delivery attended by skilled Birth attendance
Proportion of mothers attending institutional delivery in the intervention and control clusters, assessed using standard questionnaire
Measured: after 40 weeks of gestation
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
Measured: 42 days after delivery
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
Measured: 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start22 Nov 2018
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal Health ServiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Principal investigator, Netsanet Belete, Jimma University
- Investigators
- Netsanet Belete, Msc, Principal investigator, Jimma UniversityMulusew Gerbaba, PhD, Study director, Jimma UniversityGurmesa Tura, PhD, Study director, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891030
- Sponsor's protocol ID
- CBBSI/2019
- Acronym
- CBBSI
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant flow, outcome measure statistical analysis
Publications
Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving utilization of antenatal care visits in Northwest Ethiopia: a cluster randomized controlled trial. BMC Health Serv Res. 2022 Apr 9;22(1):466. doi: 10.1186/s12913-022-07894-7.
PubMed 35397607Andargie NB, Debelew GT. Effect of checklist based box system interventions on improving institutional delivery among reproductive age women in Northwest Ethiopia: generalized structural equation modeling. Arch Public Health. 2022 Jan 4;80(1):5. doi: 10.1186/s13690-021-00774-2.
PubMed 34983665Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving postnatal care utilization in Northwest Ethiopia: a cluster randomized controlled trial. Reprod Health. 2021 Nov 20;18(1):234. doi: 10.1186/s12978-021-01283-9.
PubMed 34801045Andargie NB, Jebena MG, Debelew GT. Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial. Trials. 2020 Feb 7;21(1):151. doi: 10.1186/s13063-019-4002-3.
PubMed 32033576
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03891030
- Acronym / sponsor ID
- CBBSI / CBBSI/2019
- Conditions
- Maternal Health Service
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Checklist Based Box system | Experimental | Other: Checklist Based Box system interventionPregnant 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. |
| Routine maternal health care | No intervention | –Pregnant mothers in this arm will receive the usual routine maternal health care. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist Based Box system interventionThe 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. | Other | Checklist Based Box system |
Primary outcome
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
5 secondary outcomes
Early Initiation of Antenatal care (Before 16 Weeks of Gestation)
Time frame: 16 weeks of gestation
Attending four antenatal care follow up, (36-40 weeks of gestation)
Time frame: 40 weeks of gestation
Institutional delivery attended by skilled Birth attendance
Time frame: after 40 weeks of gestation
Postnatal care follow-up (First 6 hours, 6 days and 6 weeks of delivery)
Time frame: 42 days after delivery
Knowledge towards maternal health service
Time frame: 42 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 35397607Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving utilization of antenatal care visits in Northwest Ethiopia: a cluster randomized controlled trial. BMC Health Serv Res. 2022 Apr 9;22(1):466. doi: 10.1186/s12913-022-07894-7.
- Derived from this study: PubMed 34983665Andargie NB, Debelew GT. Effect of checklist based box system interventions on improving institutional delivery among reproductive age women in Northwest Ethiopia: generalized structural equation modeling. Arch Public Health. 2022 Jan 4;80(1):5. doi: 10.1186/s13690-021-00774-2.
- Derived from this study: PubMed 34801045Andargie NB, Debelew GT. Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving postnatal care utilization in Northwest Ethiopia: a cluster randomized controlled trial. Reprod Health. 2021 Nov 20;18(1):234. doi: 10.1186/s12978-021-01283-9.
- Derived from this study: PubMed 32033576Andargie NB, Jebena MG, Debelew GT. Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial. Trials. 2020 Feb 7;21(1):151. doi: 10.1186/s13063-019-4002-3.
- Individual participant dataSharing planned: Yes. Participant flow, outcome measure statistical analysis
Related trials for Maternal Health Service
Recruiting
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
Digital Health, Maternal Health Services
Active, not recruiting
Mother and Infant Home Visiting Program Evaluation
Pregnancy, Infant Development
Recruiting
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
Human Immunodeficiency Virus, Mental Disorder
Not yet recruiting
Maternal Oral Health Educational Intervention to Improve Knowledge, Practice and Dental Service Utilization
Oral Health
Recruiting
Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations
Health Care Utilization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Netsanet Belete, Msc principal investigator
Jimma University
Mulusew Gerbaba, PhD study director
Jimma University
Gurmesa Tura, PhD study director
Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist Based Box system intervention in people with Maternal Health Service, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Netsanet Belete, Msc (+25148075941, netsanetb2009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3) (time frame: 42 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03891030, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.