NCT06431581 Effect of a Mobile Health Intervention on Birth Outcome and Infant Health
| NCT ID | NCT06431581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kathmandu University School of Medical Sciences |
| Condition | Birth Outcomes |
| Study Type | INTERVENTIONAL |
| Enrollment | 494 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 494 participants in total. It began in 2024-09-09 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight, preterm birth, and challenges in child growth and development. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviors for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery. Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes and infant health in Nepal. In the initial phase, a qualitative study will be conducted to explore the enablers and barriers of perinatal care and preferences of pregnant women through focus group discussions. These insights will inform the development of user-centered educational videos and tailored m-Health interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the m-Health intervention's effect on the birth outcomes and infant health of the pregnant women attending the antenatal care clinic of Dhulikhel Hospital. The investigaotors will randomize pregnant women at gestational age 14-22 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up). Follow-up will be done from enrollment until the child reaches one year of age, with a focus on evaluating effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery) and infant health (growth and development of the infant). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential effect of m-Health intervention on birth outcomes and infant health.
Eligibility Criteria
Inclusion Criteria: * Pregnant women of age 18 years and above; * Pregnant with 14 to 22 weeks of gestation; * Planned to deliver a child and come for infant's vaccination at Dhulikhel hospital; * Pregnant women who use smart phone; * Pregnant women who have plan to stay in Dhulikhel thorough out this study period; * Can read and understand Nepali language Exclusion Criteria: * Vision impairment and diagnosed learning difficulties
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06431581 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Birth Outcomes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06431581 currently recruiting?
Yes, NCT06431581 is actively recruiting participants. Contact the research team at bhawanakoju@kusms.edu.np for enrollment information.
Where is the NCT06431581 trial being conducted?
This trial is being conducted at Dhulikhel, Nepal.
Who is sponsoring the NCT06431581 clinical trial?
NCT06431581 is sponsored by Kathmandu University School of Medical Sciences. The trial plans to enroll 494 participants.