Clinical trial NCT05666050: Mobile Health Intervention to Improve Neonatal Care Practice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Care
Keywords: Neonatal care, Dessie, Kombolcha, Ethiopia
Lead sponsor: Wollo University
Sponsor class: OTHER
Collaborators: name: Jimma University
First posted: 2022-12-27
Enrollment: 784
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.

Exclusion Criteria:

* Pregnant women seriously ill and not able to respond.

Primary outcomes:
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).
timeFrame: Two weeks after intervention 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
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.