NCT06431581 Effect of a Mobile Health Intervention on Birth Outcomes
| 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 | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2026-12.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: * Pregnant women of age 18 years and above; * Pregnant with 13 to 27 weeks of gestation; * Planned to deliver a child at selected hospital; * Pregnant women who use smart phone; * Can read and understand Nepali language Exclusion Criteria: * Pregnant women with 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.