Other Cardiovascular Diseases of Mother, PostpartumEPPMCNCT05666037
Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake
A study testing Mobile health intervention(mHealth) in people with Other Cardiovascular Diseases of Mother, Postpartum, run by Wollo University at 1 site in Ethiopia.
Trial summary
The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other Cardiovascular Diseases of Mother, Postpartum
- What is being tested?
- Mobile health intervention(mHealth)
- 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
- 5 Dec 2022to 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All mothers who will be 24-28 week of gestation and have access to mobile phone in the study area will be recruited to this study.
Who cannot join
- Pregnant women, who will be assumed to have serious medical problems, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake Among Women in North East Ethiopia: Community Based Cluster Randomized Control Trial
The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.
Read the detailed description
The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.
Cluster randomized control trial behavioral intervention sampling technique will be deployed. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new mobile health intervention with existed health care practice and the control arm will take the existed current health care practice. Intervention mobile health messages will be developed from family planning behavior change framework and national guidelines. Data will be collected by using pre-tested interviewer administered structured questionnaires. Data will be collected in four different phases. Open data kit (ODK) will be used for data collection. Duration of intervention will be 4 months. Descriptive analyses will be made by computing proportions and summary statistics. Statistical package to social science (SPSS.26) and STATA.15 soft wares will be used to do analysis. Structural Equation Modeling (SEM) or path analysis will be done to identify the fitted components to determine latent variables.
- Being tested
- Mobile health intervention(mHealth)
- Keywords
- Early post partum, Contraceptive method, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health intervention(mHealth)Behavioural
The intervention group will receive mobile health messaging intervention on behavior change to uptake early postpartum modern contraceptive method.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive mobile health intervention. Receives: Behavioral: Mobile health intervention(mHealth) |
| Control group | No intervention | The control arm will be received the existed current health delivery approach, not received mobile health sending message service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postpartum family planning is outlined as women who have will be used any kind of modern birth control technique at intervals the primary six weeks when she gave birth.
If the respondent answers yes it will be coded "1" and if not coded as "0"
Measured: Two weeks after intervention completed 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 start5 Dec 2022
- 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 Other Cardiovascular Diseases of Mother, PostpartumStudies 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
- Masking
- None (open label)
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niguss Cherie, Wollo University
- Investigators
- Niguss Cherie, MPH, Principal investigator, Wollo Universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666037
- Sponsor's protocol ID
- JUIH/IRB/229/22
- Acronym
- EPPMC
- Status last verified
- Dec 2022
- 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 will be kept confidential
Publications
Adane M, Cherie N, Damtie Y, Malde M, Chanie MG. Sexual and reproductive health service needs among youths attending preparatory school in Debre Tabor Town, Northwest Ethiopia. SAGE Open Med. 2022 Jul 24;10:20503121221113667. doi: 10.1177/20503121221113667. eCollection 2022.
PubMed 35910818Cherie N, Wordofa MA, Debelew GT. Effectiveness of an Interactive Mobile Health Intervention (IMHI) to enhance the adoption of modern contraceptive methods during the early postpartum period among women in Northeast Ethiopia: A cluster Randomized Controlled Trial (RCT). PLoS One. 2024 Nov 14;19(11):e0310124. doi: 10.1371/journal.pone.0310124. eCollection 2024.
PubMed 39541340
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 to Improve Early Postpartum Modern Contraceptive Method Uptake Among Women in North East Ethiopia: Community Based Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05666037
- Acronym / sponsor ID
- EPPMC / JUIH/IRB/229/22
- Keywords
- Early post partum, Contraceptive method, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (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.
The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.
Detailed description
The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.
Cluster randomized control trial behavioral intervention sampling technique will be deployed. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new mobile health intervention with existed health care practice and the control arm will take the existed current health care practice. Intervention mobile health messages will be developed from family planning behavior change framework and national guidelines. Data will be collected by using pre-tested interviewer administered structured questionnaires. Data will be collected in four different phases. Open data kit (ODK) will be used for data collection. Duration of intervention will be 4 months. Descriptive analyses will be made by computing proportions and summary statistics. Statistical package to social science (SPSS.26) and STATA.15 soft wares will be used to do analysis. Structural Equation Modeling (SEM) or path analysis will be done to identify the fitted components to determine latent variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile health intervention(mHealth)The intervention group will receive mobile health intervention. |
| Control group | No intervention | –The control arm will be received the existed current health delivery approach, not received mobile health sending message service. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All mothers who will be 24-28 week of gestation and have access to mobile phone in the study area will be recruited to this study.
Key exclusion criteria (1 listed)
- Pregnant women, who will be assumed to have serious medical problems, will be excluded.
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 intervention(mHealth)The intervention group will receive mobile health messaging intervention on behavior change to uptake early postpartum modern contraceptive method. | Behavioural | Intervention group |
Primary outcome
Early postpartum family planning is outlined as women who have will be used any kind of modern birth control technique at intervals the primary six weeks when she gave birth.
Time frame: Two weeks after intervention completed the outcome will be measured.
If the respondent answers yes it will be coded "1" and if not coded as "0"
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 35910818Adane M, Cherie N, Damtie Y, Malde M, Chanie MG. Sexual and reproductive health service needs among youths attending preparatory school in Debre Tabor Town, Northwest Ethiopia. SAGE Open Med. 2022 Jul 24;10:20503121221113667. doi: 10.1177/20503121221113667. eCollection 2022.
- Derived from this study: PubMed 39541340Cherie N, Wordofa MA, Debelew GT. Effectiveness of an Interactive Mobile Health Intervention (IMHI) to enhance the adoption of modern contraceptive methods during the early postpartum period among women in Northeast Ethiopia: A cluster Randomized Controlled Trial (RCT). PLoS One. 2024 Nov 14;19(11):e0310124. doi: 10.1371/journal.pone.0310124. eCollection 2024.
- Individual participant dataSharing planned: No. The data will be kept confidential
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, MPH 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(mHealth) in people with Other Cardiovascular Diseases of Mother, Postpartum, 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?
Early postpartum family planning is outlined as women who have will be used any kind of modern birth control technique at intervals the primary six weeks when she gave birth. (time frame: Two weeks after intervention completed 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 NCT05666037, 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.