Neonatal CareNCPNCT05666050
Mobile Health Intervention to Improve Neonatal Care Practice
A study testing Mobile health intervention in people with Neonatal Care, run by Wollo University at 1 site in Ethiopia.
Trial summary
Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Care
- What is being tested?
- Mobile health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 Jan 2023to 15 Jun 2023
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.
Who cannot join
- Pregnant women seriously ill and not able to respond.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Interactive Mobile Health Intervention (IMHI) to Improve Neonatal Care Practice Among Postpartum Women in Dessie and Kombolcha Town Zones, North East Ethiopia: Behavioral Cluster Randomized Control Trial
Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.
Read the detailed description
The main aim of this study is to determine effectiveness of mobile health intervention to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new intervention with existed health care practice and the control arm will take the existed current health care practice.
The intervention arm will receive sending message service (SMS) over a four month period (90 days pre-natal and 42 days post-partum) and the control arm will receive the existed health care practice. Participants in the intervention arm will receive mobile based health education and health communication messages as well as messages on neonatal care practice based on national maternal and child health care education and counseling guidelines. Participants in this study will be randomly assigned as intervention will receive sending message service from a trained professional; while participants assigned to control group will not receive phone based interventions but can contact their health care providers as routine health facility activity. Initially, study participants will receive one text message every two weeks with the frequency increasing to messages for 42 days following delivery.
Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post par-tum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.
- Conditions
- Neonatal Care
- Being tested
- Mobile health intervention
- Keywords
- Neonatal care, Dessie, Kombolcha, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health interventionBehavioural
Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and will be continued up to 6 weeks of post partum period for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive mobile health intervention sending message service(SMS) Receives: Behavioral: Mobile health intervention |
| Control group | No intervention | The control group will receive the existed current health delivery approach, no mobile health sending message service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score).
Principal component analysis will be done to create composite index (score) and respondents who will have scored above or equal to the mean/median value will be considered as having good neonatal care, while those who will score below the mean/median value were considered as poor neonatal care.
Measured: Two weeks after intervention the outcome will be measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start15 Jan 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University
- Responsible party
- Principal investigator, Niguss Cherie, Wollo University
- Investigators
- Niguss Cherie, Principal investigator, Wollo Universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666050
- Sponsor's protocol ID
- JUIH/IRB/230/22
- Acronym
- NCP
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from the participants will be confidential.
Publications
Cherie N, Abdulkerim M, Abegaz Z, Walle Baze G. Maternity continuum of care and its determinants among mothers who gave birth in Legambo district, South Wollo, northeast Ethiopia. Health Sci Rep. 2021 Nov 2;4(4):e409. doi: 10.1002/hsr2.409. eCollection 2021 Dec.
PubMed 34754945Cherie N, Wordofa MA, Debelew GT. The effect of an interactive mobile health intervention to improve community-based essential neonatal care practices among postpartum women in northeast Ethiopia: a cluster randomized controlled trial. Int Health. 2025 Sep 3;17(5):820-835. doi: 10.1093/inthealth/ihae080.
PubMed 39789852
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interactive Mobile Health Intervention (IMHI) to Improve Neonatal Care Practice Among Postpartum Women in Dessie and Kombolcha Town Zones, North East Ethiopia: Behavioral Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05666050
- Acronym / sponsor ID
- NCP / JUIH/IRB/230/22
- Conditions
- Neonatal Care
- Keywords
- Neonatal care, Dessie, Kombolcha, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Collaborators
- Jimma University
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 27 Dec 2022 (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.
Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.
Detailed description
The main aim of this study is to determine effectiveness of mobile health intervention to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new intervention with existed health care practice and the control arm will take the existed current health care practice.
The intervention arm will receive sending message service (SMS) over a four month period (90 days pre-natal and 42 days post-partum) and the control arm will receive the existed health care practice. Participants in the intervention arm will receive mobile based health education and health communication messages as well as messages on neonatal care practice based on national maternal and child health care education and counseling guidelines. Participants in this study will be randomly assigned as intervention will receive sending message service from a trained professional; while participants assigned to control group will not receive phone based interventions but can contact their health care providers as routine health facility activity. Initially, study participants will receive one text message every two weeks with the frequency increasing to messages for 42 days following delivery.
Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post par-tum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile health interventionThe intervention group will receive mobile health intervention sending message service(SMS) |
| Control group | No intervention | –The control group will receive the existed current health delivery approach, no mobile health sending message service |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.
Key exclusion criteria (1 listed)
- Pregnant women seriously ill and not able to respond.
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 |
|---|---|---|
| Mobile health interventionPregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and will be continued up to 6 weeks of post partum period for 4 months. | Behavioural | Intervention group |
Primary outcome
Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score).
Time frame: Two weeks after intervention the outcome will be measured.
Principal component analysis will be done to create composite index (score) and respondents who will have scored above or equal to the mean/median value will be considered as having good neonatal care, while those who will score below the mean/median value were considered as poor neonatal care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Results publication: PubMed 34754945Cherie N, Abdulkerim M, Abegaz Z, Walle Baze G. Maternity continuum of care and its determinants among mothers who gave birth in Legambo district, South Wollo, northeast Ethiopia. Health Sci Rep. 2021 Nov 2;4(4):e409. doi: 10.1002/hsr2.409. eCollection 2021 Dec.
- Derived from this study: PubMed 39789852Cherie N, Wordofa MA, Debelew GT. The effect of an interactive mobile health intervention to improve community-based essential neonatal care practices among postpartum women in northeast Ethiopia: a cluster randomized controlled trial. Int Health. 2025 Sep 3;17(5):820-835. doi: 10.1093/inthealth/ihae080.
- Individual participant dataSharing planned: No. The data from the participants will be confidential.
Related trials for Neonatal Care
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingObservational study
Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)
Amyloid Cardiomyopathy
Not yet recruiting
Effect of Gamified Neonatal Initial Care Education on Midwifery Students
Midwifery Education, Neonatal Care Education
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
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.
Niguss Cherie principal investigator
Wollo Universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health intervention in people with Neonatal Care, run by Wollo 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: finished, as of the sponsor's last update on 30 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score). (time frame: Two weeks after intervention the outcome will be measured.). 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 NCT05666050, which also lists 2 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 30 Mar 2025.