Effect of Mobile Health Integrated Antenatal Care Intervention in Improving Maternity Continuum of Care, Obstetric Health Literacy, Maternal and Perinatal Outcomes in Public Hospitals, Ethiopia: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Continuum of maternity care
研究概览
简要总结
The World Health Organization (WHO) has released wide-ranging guidelines on antenatal care (ANC) with the aiming to provide ongoing maternity care and "positive pregnancy experience". In this regard, the Safe Delivery App (SDA) and Health for All App provide animated clinical instruction videos in basic emergency obstetric and neonatal care, has been developed and recommended to be implemented in maternity health care. Though mobile health (mHealth) technology shows immense potential in improving healthcare services, evidence of its effectiveness had not been previously seen in Ethiopia.
Objectives: This study aims to assess effect of mHealth integrated ANC intervention in improving maternity continuum of care utilization, obstetric health literacy, and maternal and perinatal outcomes in Public Hospitals in East Gojjam Zone, North-West, Ethiopia, 2024/2025.
Methods: an interventional two-arm pragmatic cluster randomized controlled trial (RCT) will be conducted at six (three for each arm) primary Public Hospitals in East Gojjam Zone, North-West, Ethiopia, from April 1st to December 30th 2024. About 520 (260 for each arm) low-risk pregnant women having an access to smartphones and coming for 1st ANC contact within the first 12 weeks of gestation will be identified, requested and recruited for the study in both arms. Thereafter, those eligible women in the intervention arm will receive the application and practical training of mHealth solution in addition to the routine ANC services. Data will be collected 4 times, just at the baseline, end of ANC contact, at delivery and within 7 days of post natal period through record review, client interview and observation. The quantitative data will be analyzed using a chi-squared test, independent t-test, paired t-test, intention-to-treat (ITT) and per protocol (PP) analysis. Generalized linear mixed effect modeling will be used and the intervention's effect on our pre-specified objectives will be assessed using a relative risk (RR) measure of association along with non-inferior and superior analysis. Qualitative data will be collected from both the healthcare providers and clients to experience about the acceptability, feasibility and sustainability of integrating mHealth interventions.
Expected outcomes: includes maternity continuum of care, obstetric health literacy, birth preparedness and complication readiness plan and satisfaction, maternal and perinatal outcomes
详细描述
Background: Maintaining the best possible health for the mother and newborns is still a challenge in Sub-Saharan Africa (SSA), including Ethiopia (1). The high toll of maternal and child mortalities remains the single most important challenge to the health sector (2). In low-income countries, hypertensive disorders of pregnancy (HDP), obstetric hemorrhage (OH), and sepsis are the most common drivers of maternal morbidity and mortality (3). Preventive measures that are straightforward and evidence-based are likely to prevent catastrophic morbidity and mortality during pregnancy (4). ANC is crucial for ensuring positive maternal and perinatal outcomes (5).
The WHO recommends establishing a broader package of interventions to increase individual, family, and community capacity to contribute to maternal and newborn health improvements and to increase use of skilled care during pregnancy, for childbirth, and after birth (5,6). The Health for All application is developed by scholars from the University of Gondar and granted by the International Institute for Primary Health Care - Ethiopia and the Ethiopian Ministry of Health. The Health for All app contains detailed information on family planning packages, ANC packages (updated 8 contacts), birth preparedness and complication readiness, skilled delivery, maternal nutrition, danger signs during ANC, perinatal periods, post-partum family planning, and postnatal care, but has not yet been implemented in Ethiopia. Therefore, this study will implement integrated services during ANC that may contribute to changes in healthcare-seeking during the perinatal period, ensure ongoing maternity care, and provide a positive pregnancy experience.
Even though maternal and neonatal health has received significant attention during the present Sustainable Development Goal (SDG) period, maintaining the best possible health for both the mother and newborns is still a challenge in Sub-Saharan Africa (SSA) (7). Ethiopia is one of the sub-Saharan countries with the highest toll of maternal and child mortalities; it remains the single most important challenge to the health sector (i.e., 401 MMR per 100,000 live births,and the perinatal mortality rate is 33 deaths per 1000 (8). The continuum of maternal care completion rate was extremely low (2). According to the 2019 Ethiopian mini demographic health survey report, about 57% of pregnant women didn't get optimum antenatal care (14), 69.1% of women dropped out of the maternity continuum of care (9). To increase pregnant women's adherence to the continuum of care, thereby reducing morbidity and mortality, mobile Health (mHealth) Apps are essential tools accessible through smartphones, empowering women with the health information they need to take control of their well-being like never before (10). These innovations are essential to improve women's limited understanding of the need for maternal health services, and harmful cultural norms pose obstacles to women's healthcare service utilization (11). Moreover, mHealth innovative applications enable users to learn about their conditions, promote lifestyle modifications during pregnancy, treatment options, and preventive measures, promoting informed decision making, access health information, and seek care (7,12-15). However, there is limited integrated uptake of this digital health solution in the maternal and child healthcare service delivery processes due to a lack of adequate information about the presence of these updated and evidence-based mHealth Apps (i.e., Safe Delivery and Health for All). Moreover, the lack of practical implementation experience is limiting Ethiopia's ability to move toward maturing its digital healthcare. Hence, healthcare providers and women's engagement are key components of effective healthcare, and mHealth apps have emerged as a game-changer in this domain.
Evidence revealed that mHealth interventions have emerged as a promising solution to improve maternal and child health outcomes. Despite the acceptance and effectiveness of mHealth being widely documented in literature, little to no research has been done in Ethiopia.
Research question: Does implementation of the mHealth integrated antenatal care intervention have a significant effect on improving maternity continuum of care, obstetric health literacy, and maternal and perinatal outcomes? Research hypothesis: Implementation of the mHealth integrated antenatal care intervention will improve maternity continuum of care, obstetric health literacy, and maternal and perinatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low-risk pregnant women
- •Pregnant women having access to a smartphone
- •Coming for the 1st ANC contact within the first 12 weeks of gestation
- •Willing to participate in the study
排除标准
- •High-risk pregnant women
- •Pregnant women who have no access to a smartphone
- •Those pregnant women coming for the 1st ANC contact after 12 weeks of gestation
- •Unwilling to participate in the study
研究组 & 干预措施
two arms
This is a Two arm pragmatic RCT study( one intervention and one control group). The intervention group was pregnant women who assigned to use Health for all mobile health application in addition to the routine ANC contact and the control group was those pregnant women allowed to continue only the routine ANC contact.
干预措施: Health for All Mobile health application (Device)
Control arm
pregnant women in the control arm were those who took the routine ANC follow up without additional intervention
结局指标
主要结局
Continuum of maternity care
时间窗: Up to seven days of the postnatal period
Percent of pregnant women who utilize maternal health services continuously (adherence to the 8 ANC contacts or six uninterrupted ANC but give birth before the next contact + institutional delivery + at least one postnatal care utilization after discharge within 7 days), which was measured using a structured questionnaire
Obstetric Health Literacy
时间窗: 40 weeks of pregnancy
Obstetric Health Literacy about pregnancy danger signs, birth preparedness, and complication readiness plan was measured with knowledge-related questions and categorized as good or poor based on the mean score of the questions.
Maternal health outcomes
时间窗: Up to seven days of post postpartum period
The percentage (%) of pregnant women who have good or bad maternal health outcomes, considering major pregnancy, childbirth, and early postnatal complications, measured via a structured questionnaire.
Perinatal outcomes
时间窗: Up to seven days of post postpartum period
The percentage (%) of pregnant women who have good or bad perinatal outcomes, considering gestational age during delivery, stillbirth, birth weight, perinatal Birth asphyxia, Neonatal Intensive Care unit admission, and early neonatal deaths, measured by a structured questionnaire
次要结局
未报告次要终点
研究者
Yibelu Bazezew Bitewa
Assistant professor
Debre Markos University
