Effect of a Mobile Health Intervention on Birth Outcomes

Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. 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 behaviours 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 in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women. A two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 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 the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.

NCT Number	NCT06431581
Lead Sponsor	Kathmandu University School of Medical Sciences
Conditions	Birth Outcomes
Enrollment	494 participants
Start Date	2024-09-09
Primary Completion	2026-12 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-24