- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666037
Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake (EPPMC)
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mulemebet Abera, PhD
- Phone Number: +251985171738
- Email: mulu_abera.ts2009@yahoo.com
Study Contact Backup
- Name: Niguss Cherie, MPH
- Phone Number: +251910749743
- Email: nigucheru@gmail.com
Study Locations
-
-
South Wollo
-
Dessie, South Wollo, Ethiopia, 1145
- Recruiting
- Dessie and Kombolcha
-
Contact:
- Niguss Cherie
- Phone Number: 0910749743
- Email: nigucheru@gmail.com
-
Contact:
- Mulumebet Abera, PhD
- Phone Number: +251985171738
- Email: mulu_abera.ts2009@yahoo.com
-
Sub-Investigator:
- Gurmesa Tura, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Pregnant women, who will be assumed to have serious medical problems, will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
The intervention group will receive mobile health intervention.
|
The intervention group will receive mobile health messaging intervention on behavior change to uptake early postpartum modern contraceptive method.
|
No Intervention: Control group
The control arm will be received the existed current health delivery approach, not received mobile health sending message service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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"
|
Two weeks after intervention completed the outcome will be measured.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niguss Cherie, MPH, Wollo Universirty
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JUIH/IRB/229/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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