NCT07091188

Brief 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 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,920

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

July 6, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 6, 2025

Last Update Submit

July 25, 2025

Conditions

Keywords

antenatal careethnic minoritydigital healthhealth education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Rate of Negative Pregnancy Outcomes

    Data will be collected at the end of the pregnancy

  • Rate of Pregnancy-Related Diseases

    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

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

Study Arms (2)

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

Behavioral: Health education, capacity building and economic incentives

Control group

NO INTERVENTION

No intervention will be applied

Interventions

1. 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.

Intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women

You may not qualify if:

  • Not pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pregnancy ComplicationsHealth Education

Interventions

Capacity Building

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and ServicesOrganization and AdministrationHealth Services AdministrationPandemic PreparednessDisaster PlanningDisastersEnvironmentEnvironment and Public HealthCommunicable Disease ControlPublic Health PracticePublic Health

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 29, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to privacy considerations and data minimization principles.