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NCT Number: NCT07091188

A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches

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.

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Key information

Conditions

Antenatal Care Adherence Interventions Behavior Female Urogenital Diseases and Pregnancy Complications Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Pregnancy Complications Pregnancy Outcomes Treatment Adherence and Compliance Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women

Exclusion criteria

  • Not pregnant women

Treatment and study plan

Health education, capacity building and economic incentives

Behavioral
  • Social media platform-based for health education. Pregnant women in the same gestational month will be invited to join specific WeChat group chats tailored to their similar health education and management needs.
  • Capacity building. ANC providers at township hospitals will participate in short-term, small-class training courses designed to cover essential aspects of antenatal care prior to the intervention with the pregnant women.
  • Economic incentives. To encourage ANC attendance, a monetary reward system will be implemented for village doctors every time they successfully identify and invite a newly pregnant woman to initiate her ANC visit.

Primary outcomes

  1. Rates of Hospital Deliveries and Completion of Five Antenatal Care Visits

    Time frame: Data will be collected at the end of the pregnancy

    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.

Secondary outcomes

  1. Rate of Negative Pregnancy Outcomes

    Time frame: Data will be collected at the end of the pregnancy

    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.

  2. Rate of Pregnancy-Related Diseases

    Time frame: Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year

    Pregnancy-related disorders, such as gestational anaemia, gestational hypertension, preeclampsia and gestational hyperglycaemia will be recorded.

  3. Number of Tests Conducted

    Time frame: Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr

CONTACT

[email protected]

8657188208221

Sponsors and collaborators

Lead sponsor

Jiayao Xu

Other

Registry information

Official study title

A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches (CALCIUM) Among an Ethnic Minority Community in China

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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