Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- Birth weight
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant women with vision impairment and diagnosed learning difficulties
研究组 & 干预措施
Control Group (standard care, control video and reminder phone call for follow up)
A control group will receive standard care along with a control video and reminder phone call for follow-up
结局指标
主要结局
Birth weight
时间窗: 1-1.5 years
The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared.
Gestational age at delivery
时间窗: 1-1.5 years
The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group.
次要结局
- Knowledge on perinatal care(6 months)
- Weight of the infant(2-2.5 years)
- Height/Length of the infant(2-2.5 years)
- Development of an infant(2-2.5 years)
研究者
Bhawana Shrestha
Assistant Professor
Kathmandu University School of Medical Sciences