Clinical trial NCT05666037: Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Cardiovascular Diseases of Mother, Postpartum
Keywords: Early post partum, Contraceptive method, Ethiopia
Lead sponsor: Wollo University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 784
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Two weeks after intervention completed the outcome will be measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Dessie
country: Ethiopia
facility: Dessie and Kombolcha
state: South Wollo
Study officials:
affiliation: Wollo Universirty
name: Niguss Cherie, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.