Antenatal CareNCT07091188
A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches
A study testing Health education, capacity building and economic incentives in people with Antenatal Care and Pregnancy Complications, run by Jiayao Xu.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Care, Pregnancy Complications, Pregnancy Outcomes
- What is being tested?
- Health education, capacity building and economic incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women
Who cannot join
- Not pregnant women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches (CALCIUM) Among an Ethnic Minority Community in China
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.
Read the detailed description
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.
- Conditions
- Antenatal Care, Pregnancy Complications, Pregnancy Outcomes
- Being tested
- Health education, capacity building and economic incentives
- Keywords
- antenatal care, ethnic minority, digital health, health education
- Medical subject headings
- Pregnancy Complications, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education, capacity building and economic incentivesBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Health education, capacity building and economic incentives |
| Control group | No intervention | No intervention will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected at the end of the pregnancy
Secondary outcomes (3)
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.
Measured: Data will be collected at the end of the pregnancy
Rate of Pregnancy-Related Diseases
Pregnancy-related disorders, such as gestational anaemia, gestational hypertension, preeclampsia and gestational hyperglycaemia will be recorded.
Measured: 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.
Measured: Data will be collected from pregnancy through the end of the study, with an average follow-up duration of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiayao Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiayao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091188
- Sponsor's protocol ID
- ZGL202408-7
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy considerations and data minimization principles.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Adapted Digital Intervention to Promote Maternal Care Utilization Using Multifaceted Approaches (CALCIUM) Among an Ethnic Minority Community in China
- ClinicalTrials.gov ID
- NCT07091188
- Acronym / sponsor ID
- ZGL202408-7
- Conditions
- Antenatal Care, Pregnancy Complications, Pregnancy Outcomes
- Keywords
- antenatal care, ethnic minority, digital health, health education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Jiayao XuUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health education, capacity building and economic incentivesInterventions including digital health education via social media platform, capacity building for healthcare providers and economic incentives for village doctors will be applied |
| Control group | No intervention | –No intervention will be applied |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women
Key exclusion criteria (1 listed)
- Not pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education, capacity building and economic incentives1. 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. 2. 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. 3. 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. | Behavioural | Intervention group |
Primary outcome
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.
3 secondary outcomes
Rate of Negative Pregnancy Outcomes
Time frame: Data will be collected at the end of the pregnancy
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy considerations and data minimization principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Health education, capacity building and economic incentives in people with Antenatal Care and Pregnancy Complications, run by Jiayao Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr (8657188208221, xujiayao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Hospital Deliveries and Completion of Five Antenatal Care Visits (time frame: Data will be collected at the end of the pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.