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Maternal healthcare utilization is crucial for reducing maternal mortality, yet remains low in many underserved regions. The CALCIUM intervention, a culturally tailored, digital platform-integrated intervention, was developed to promote antenatal care (ANC) and institutional deliveries in Liangshan Yi Autonomous Prefecture, an ethnic minority community in China. The CALCIUM intervention was developed to address barriers including limited healthcare awareness, traditional norms and low-quality services. This intervention will evaluate the effectiveness, and cost-effectiveness of improving maternal healthcare utilization and pregnancy outcomes in an ethnic minority community.
A cluster quasi-randomised control trial will be conducted in two counties, Xide and Yuexi, in Liangshan Yi Autonomous Prefecture, Sichuan province, China. In total, 12 towns will be randomly selected from each of the two counties (i.e., Yuexi and Xide). Within each county, the selected towns will be randomly and evenly assigned to the intervention and control groups. In each town, 80 newly pregnant women will be invited to participate. The comprehensive intervention was designed based on the Behaviour Change Wheel (BCW) including digital health education via social media platform, capacity building for healthcare providers and economic incentives for village doctors. Primary outcomes include the rates of hospital delivery and ANC utilization. Secondary outcomes include participants' pregnancy-related diseases and pregnancy outcomes. Primary and secondary outcomes will be collected through the local maternal and newborn health monitoring system. Sociodemographic and process information will be gathered through postpartum interviews. A logistic mixed model with an intention-to-treat approach will be used to evaluate the effectiveness of the intervention. Additionally, intervention costs and cost-effectiveness will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Interventions including digital health education via social media platform, capacity building for healthcare providers and economic incentives for village doctors will be applied |
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| Control group | No Intervention | No intervention will be applied |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health education, capacity building and economic incentives | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of Hospital Deliveries and Completion of Five Antenatal Care Visits | The primary outcome includes the rate of maternal care utilization, including the rate of hospital delivery and ANC utilization. According to the National Basic Public Health Service Specifications, pregnant women are advised to have their first ANC visit by the 13th week of gestation, with subsequent visits recommended during the 16-20, 21-24, 28-36, and 37-40 week periods. Timely initiation of ANC is defined as pregnant women completing their first ANC visit by the 13th week of gestation. Timely completion of five ANC visits is defined as pregnant women completing all five recommended ANC visits within the specified timeline. ANC utilization is measured by the completion of five ANC visits, the timely completion of five ANC visits, and timely initiation of ANC. The maternal and newborn health monitoring system collects routine information related to ANC utilization, place of delivery, maternal outcomes, and birth outcomes. Data will be sourced from this system. | Data will be collected at the end of the pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Negative Pregnancy Outcomes | Participants' negative pregnancy outcomes, such as maternal death, neonatal death, postpartum haemorrhage, perinatal asphyxia, preterm birth (PTB), large for gestational age (LGA), small-for-gestational age (SGA), congenital malformations and neonatal intensive care unit admission. | Data will be collected at the end of the pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr | Contact | 8657188208221 | xujiayao@zju.edu.cn |
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IPD will not be shared due to privacy considerations and data minimization principles.
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| ID | Term |
|---|---|
| D057191 | Capacity Building |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D000096763 | Pandemic Preparedness |
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| Rate of Pregnancy-Related Diseases | Pregnancy-related disorders, such as gestational anaemia, gestational hypertension, preeclampsia and gestational hyperglycaemia will be recorded. | Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year |
| Number of Tests Conducted | The number of tests conducted for full blood count, blood pressure measurement, Down Syndrome screening, Nuchal Translucency screening, and 3D/4D ultrasound during ANC will be collected. | Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004189 | Disaster Planning |
| D004190 | Disasters |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |