Effect of a Mobile Health Intervention on Birth Outcomes

To evaluate the effect of mobile health intervention on birth outcomes, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher will employ purposive sampling to select pregnant women visiting antenatal care clinic of selected hospital. Written informed consent will be obtained from research participants. Focus group discussions will be conducted with pregnant women to explore their views, informational needs and preferences regarding utilization of mHealth intervention. An educational video will be developed based on the findings of the qualitative study. After the video is developed, it will be validated by both expert and user groups to ensure its relevance, accuracy, and suitability. Additionally, the acceptability of the intervention will be assessed. The researcher will ensure that the educational video is user-centred by involving both experts and end users (pregnant women) throughout the design and development process.

After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD.

Phase 1: Recruitment, baseline data collection and randomization:

The head of the obstetrics and paediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinics, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 13 to 27 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at selected hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "pregnancy care for a healthy birth" from the participants in both the intervention and control groups.

Phase 2: Delivery of the intervention:

Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed.

Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events:

• During the baseline data collection phase, the initial educational video addressing "pregnancy care for a healthy birth" will be viewed by participants via a tablet in a separate designated setting.
• Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy.
• Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic.
• To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrolment as per the reminder schedule.
• Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others.

Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit.

Phase 3: Follow up

Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits.

• Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of pregnancy care for healthy birth will be assessed approximately one month following the participants' initial viewing of the videos.

• Birth outcomes assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes.